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March 12
mikehavRx.com News Bytes: $DCTH, $TRA, $POT, $SUPG, $ACCP.OB, $AMLN
This pick is about: Potash Corp. of Saskatchewan Inc. (POT)
| Rating: |
$126.04 (03/12/10)
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-67.95%
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1193 days
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HavRx Global Crop Science Index: Potash (NYSE: POT) is poised to open trading at new highs after posting strong earnings and upping its guidance. Meanwhile, Yara International (OTC: YARIY.PK) has withdrawn its bid for Terra Industries (NYSE: TRA), which will be acquired by CF Industries (NYSE: CF). In addition, Agrium (NYSE: AGU) has dropped its hostile bid for CF. <font> Delcath Systems (NASDAQ: DCTH) is an emerging, small-cap medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath's Percutaneous Hepatic Perfusion (PHP) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient's entire body to the anti-cancer drugs, representing an elegant solution that promises to increase the effectiveness of approved anti-cancer drugs while reducing systemic side effects. </font> <font> DCTH conducted an update conference call today and still expects pivotal study results in April. The pending FDA filing will be based on these results with Fast Track status and rolling submission to expedite the process while a filing for CE Mark (Europe) clearance as a Class III medical device is now expected by year-end. </font> <font> Amylin Pharma (NASDAQ: AMLN), Eli Lilly (NYSE: LLY), and Alkermes (NASDAQ: ALKS) have a financial stake in a pending FDA decision that is expected today for a new once-weekly formulation of diabetes drug Byetta (exenatide LAR). </font> <font> Access Pharma (OTC: ACCP.OB) has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone or hGH, erythropoietin or EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics (sRNAi), and monoclonal antibodies). On Thursday, Access announced that it received reports from its two bio-pharmaceutical collaborators for oral insulin, which independently confirmed previous results by the Company for oral bio-availability in preclinical animal models of greater than 80% as compared to subcutaneous injections of insulin. </font> <font> Access reported several ongoing negotiations with additional companies that are interested in its Cobalamin Oral Drug Delivery Technology while simultaneously evaluating options for advancing oral insulin to proof-of-concept studies in humans as soon as possible. Based upon previous guidance, Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000). </font> <font> Earlier this morning, Eisai Inc. (OTC: ESALY.PK) announced FDA approval for a five-day dosing regimen for anti-cancer drug Dacogen (decitabine) to treat patients with myelodysplastic syndromes (MDS). Dacogen was approved by FDA in May 2006 for a three-day regimen and developed by SuperGen (NASDAQ: SUPG) and MGI Pharma (which was since acquired by Eisai). </font> <font> mikehavRx.com Index Updates is a premium service that provides investors with time-saving information and updates on unique global baskets of stocks that are organized and managed within the 18 HavRx Stock Indexes outlined below that are being tracked at the Investars YOU website since June 2009. Please visit </font> <font> www.mikehavRx.com </font> <font> for more details on my new publishing company, website, and premium service. </font> <font> Disclosure: Long ACCP.OB, DCTH </font>
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March 10
mikehavRx.com Index Updates Service Debut
This pick is about: SPDRs (SPY)
| Rating: |
$114.46 (03/10/10)
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| Gain/Loss: |
+41.32%
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1195 days
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mikehavRx.com Index Updates is a premium service that provides investors with time-saving information and updates on unique global baskets of stocks, including the actively managed Regulatory Catalyst Index that includes daily updates on select pending binary events within the healthcare sector such as FDA decisions and clinical trials.
www.mikehavRx.com
The actively managed HavRx Regulatory Catalyst Index tracks the performance of select companies which meet any of the following requirements: (1) pending new drug, biological agent, medical device, or diagnostic product applications at the FDA; (2) pending pivotal clinical trial results that are designed to support a new filing or resubmission for FDA marketing clearance; and (3) pending early stage clinical study results. Categories (1) and (2) will comprise two-third (67%) or greater of all index components while companies with pending early stage clinical trial results will comprise one-third (33%) or less of all index components.
The service is provided in the form of PDF files at the subscriber home page which can be accessed upon successful log-in. Currently, 20 PDFs are available to premium subscribers, including 17 files for each of the passively managed index components and three files for the Regulatory Catalyst Index, including one sorted by company name, one sorted by catalyst date, and one sorted by stock price that will updated daily on regular business / market days.
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March 05
$CLSN: Griffin Rates Celsion Buy, $10 Price Target
This pick is about: Celsion Corp (CLSN)
| Rating: |
$3.7999 (03/05/10)
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-62.89%
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1200 days
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Griffin Securities issued an update research report for Celsion (NASDAQ: CLSN) earlier this week with a buy rating and raised its 12-month price target to $10 per share, compared to an intra-day stock price of $3.80 per share today for the Company. Celsion is an active component in the HavRx Regulatory Catalyst and Emerging Cancer Dx / Tx Indexes . Below is a summary of the mid to late-stage clinical development programs for ThermoDox (Lyso-Thermosensitive Liposomal Doxorubicin): http://www.mikehavrx.com/blog/bid/17378/CLSN-Griffin-Rates-Ce... Global Phase 3 HEAT Study under SPA: for treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer under SPA, expects to complete enrollment 3Q10, interim efficacy data 2H10 (upon 190 events), NDA filing 1Q11 First Stage (Phase I/II) of Pivotal DIGNITY Clinical Trial: Expects data from first stage of recurrent chest wall (RCW) breast cancer 4Q10, expected completion of patient enrollment in the pivotal RCW study during 2H11 Pending Phase 2 Clinical Trial: Expects to begin Phase 2 study 2H10 in combo with Radio-frequency Ablation (RFA) for treatment of Colorectal Liver Metastases Disclosure: No positions. mikehavRx.com Publishing, LLC is not compensated or incentivized in any way to write about, feature, or distribute reports and other information about public-traded companies. Please contact me if you would like to submit reports for possible distribution at http://www.mikehavrx.com/
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March 04
mikehavRx.com Index Updates Service
This pick is about: Pharmaceutical HOLDRs Trust Pharmaceutical HOLDRs Trust (PPH)
| Rating: |
$64.94 (03/04/10)
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-28.32%
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1201 days
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This is a new premium service that will provide investors with time-saving research, information, and updates on unique global baskets of stocks that are organized and managed within my 18 HavRx Stock Indexes -
Regular pricing for the service is $300 per year, including a special introductory price of $200 per year through May 31, 2010 (which includes an average of less than $1 per business day update for the Regulatory Catalyst Index update reports over one year) -
This service is offered by mikehavRx.com Publishing, LLC and was created by Mike Havrilla , who will continue to manage the service as his exclusive focus in the future, in addition to writing related articles and commentaries at this website -
This new service is unrelated to any of my previous website affiliations and has been created to integrate daily updates for the actively managed Regulatory Catalyst Index with select updates in a unique, executive summary format for pending binary events such as FDA decisions and clinical trial results -
These indexes can be used as the basis for macro investing strategies (e.g. air transport index bullish / bearish based on global economic outlook), healthcare niche / sub-sector investing strategies (e.g. stem cells, Health IT, generic drugs), and niche industry group investing strategies (e.g. railroads, trucking / logistics, tobacco) which are not currently available through exchange-traded funds (ETFs), mutual funds, etc. -
Daily updates will be posted by 830pm (ET) on regular business days (when U.S. stock markets open for full day of trading, excluding holidays, weekends, and partial market days) for the Regulatory Catalyst Index Updates in the format illustrated below -
Some foreign-listed, ADRs, Pink Sheet stocks, etc. may not have complete data available for all categories as shown in sample below, but this service will include at least the company name, stock ticker, and market cap data for all index component stocks -
Investars YOU is an independent, third-party website which provides tracking data and performance statistics for my indexes since June 2009 at starting values of $1,000 at the dates indicated for each index -
Common Abbreviations : RegCat = Regulatory Catalyst Index Status, NDA = New Drug Application, BLA = Therapeutic Biologic Application, sNDA / sBLA = supplemental NDA / BLA, ANDA = Abbreviated NDA (Generic Drugs), SPA = Special Protocol Assessment, K = thousand M = million, B = billion, CRL = Complete Response Letter, PMA = Pre-Market Approval (Medical Devices / Diagnostics) -
Active vs. Passive Index Management : For the purposes of this premium service and my index management, passively managed indexes will be defined as 10% or fewer changes per month, which is based on the total number of stocks in each index (e.g. a 50-stock passively managed index would have five or fewer changes per month). The actively managed Regulatory Catalyst Index will have more frequent changes to index components, defined as greater than 10% changes to the component stocks in this index per month (i.e. this would currently equate to nine or more changes to the index per month based on 85 component stocks that are included in the index).
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Bullish on ZIOP ...
This pick is about: ZIOPHARM Oncology Inc (ZIOP)
| Rating: |
$3.53 (03/04/10)
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| Gain/Loss: |
-41.08%
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1201 days
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$ZIOP Griffin Securities Rates Ziopharm Oncology ($ZIOP) Buy with $8 Price Target http://bit.ly/avypBX
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February 05
Updated Executive Summary for Access Pharma (OTC: ACCP.OB)
This pick is about: Access Pharmaceuticals Inc. (ACCP)
| Rating: |
$0.0 (02/05/10)
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n/a
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1228 days
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 Access Pharma (OTC: ACCP.OB) is an emerging bio-pharmaceutical company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to a treatment called MuGard that is cleared for marketing in the U.S., Europe, and other key global markets for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). In addition, the Company is developing earlier stage compounds in its pipeline and has an oral cobalamin nanopolymer drug delivery technology which has demonstrated positive results for the delivery of insulin by mouth in preclinical animal models. Access expects to maintain a low cash burn rate of approximately $5 million during 2010, as compared to an operating budget of approximately $35 million - reflecting the significant benefit provided by partner funding such as the clinical development of ProLindac in the Asia-Pacific region. In addition, the current cash and expected milestone payments this year provides adequate funding for all development and commercialization plans through at least mid-2011, which does not take into account MuGard royalties from SpePharm in Europe and pending sales of the product in North America. Last December, ACCP.OB provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. MuGard is commercially launched by Access' partner, SpePharm, in six European countries, including the UK, Germany, Italy, Norway, Greece and Sweden. Access is conducting pre-marketing activities, including ramping of commercial production, with the goal of a commercial launch during March / April 2010 in U.S. Over 15,000 bottles of MuGard have been used by over 2,000 patients since launch. SpePharm is currently gathering feedback from clinicians in the UK, Germany and Italy that are participating in a patient assessment project and expects that out of a total of approximately 1,500 patients who will be given MuGard in this project, a consistent number of patient forms will be collected by year end, and the information will be quality checked for potential presentation at a scientific or medical conference or meeting during 1H10, such as the Multinational Association of Supportive Care in Cancer (MASCC) that will be held June 24-26 in Vancouver. Thiarabine is ACCP's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Access is currently working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and B-Cell lymphomas. These pilot studies are expected to begin during 2Q10 and will seek to determine the optimal dosage regimen and most susceptible malignancies for future trials to serve as the basis for partnership discussions for further development and commercialization. In early January, Access announced successful results in a small, pilot study that validates the new, scalable manufacturing process for ProLindac that is a key component for partnership discussions and large-scale production of the drug for late-stage / pivotal studies and potential commercialization. ProLindac is a next-generation DACH platinum anti-cancer compound which includes a proprietary nano-polymer drug delivery vehicle that allows for over 10X the dose of platinum to be delivered in a targeted manner to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. Access will also conduct a combination study evaluating ProLindac plus Taxol (paclitaxel) for second-line treatment of platinum pre-treated patients with advanced ovarian cancer. This is a multi-center study being conducted in Europe in up to 25 evaluable patients with primary efficacy endpoint goal of achieving at least a 63% response rate and expects to begin patient dosing by March-April 2010. The initial cohort of about 10 patients will begin the study as an open-label, dose-escalation study that is expected to provide initial results during 3Q09 and a possible partnership or larger pivotal Phase 3 trial could begin during 2H10. Access has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone/hGH, erythropoietin/EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics, monoclonal antibodies). This drug delivery technology involves coating a nano-particle with a vitamin B-12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in exponential increases in absorption through the gut of large molecule drugs / hormones typically administered by injection. In June 2009, Access announced that two bio-pharmaceutical companies (one North American, one European) would conduct preclinical, proof-of-concept studies in animals (rat and dog models of diabetes) before proceeding to more formal negotiations for the Company's oral, long-acting (basal) insulin product candidate, seeking to validate the greater than 80% oral insulin bioavailability results achieved by Access in preclinical studies for its oral insulin formulation. Final results from the non-exclusive collaborators are possible during 1Q10 while Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000), and also plans to file an additional patent application reflecting improvements to the technology. With the recently announced financing that included the sale of common stock / warrants at $3 per share, Access will have approximately $7 million in cash / equivalents and 25 million shares of common stock outstanding on a fully diluted basis (up to 30 million shares taking into account outstanding warrants, etc.) plus a $5.5 million note outstanding which is due at the end of 2011. The outstanding note is expected to be paid in part or full by possible upfront payments as part of co-promotion licensing deal(s) for MuGard in North America which could be combined with a reset of the current $27.50 conversion price. Additional analyst coverage is also possible throughout 2010, including firms such as Rodman & Renshaw (NASDAQ: RODM), which served as the sole lead placement agent in the recently closed financing. Also, listing of Access shares is anticipated on the AMEX, which should provide greater liquidity and improved bid / ask spreads for trading of the stock. Finally, MuGard sales projections at 12-months post-launch include annualized revenue run rates of $30 million for Europe at 20-25% royalties (i.e. $2.5 million per month) and $50 million for North America (i.e. approximately $4 million per month. Disclosure: Long ACCP.OB
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January 27
This pick is about: AETERNA ZENTARIS (AEZS)
| Rating: |
$0.87 (01/27/10)
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| Gain/Loss: |
+117.24%
in
1237 days
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Keryx / Aeterna Drug Shows Promise in Late-Stage Colon Cancer Patients
This pick is about: Keryx Biopharmaceuticals Inc. (KERX)
| Rating: |
$2.75 (01/27/10)
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| Gain/Loss: |
+153.82%
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1237 days
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The ProActive News Room website for Keryx Biopharma (NASDAQ: KERX) has been updated to include the Company’s most recent corporate presentation and the GI-ASCO 2010 poster presentation from last weekend. In the randomized Phase 2 trial, perifosine + capecitabine (P-CAP) demonstrated a statistically significant improvement in TTP (time to progression) and OS (overall survival) compared to placebo + capecitabine (CAP) in patients with second or third-line mCRC (metastatic colorectal cancer). ORR (overall response rate) was also improved for P-CAP over CAP. <o:p> </o:p> Perifosine is in-licensed by KERX from Aeterna Zentaris (NASDAQ: AEZS). During 2010, KERX expects to report updated data from its Phase 2 colon cancer study, conduct / update additional earlier stage Phase I/II studies, finalize late-stage trial protocol for colon cancer study, and begin a late-stage study for colon cancer patients in addition to the ongoing pivotal Phase 3 study for multiple myeloma under a Special Protocol Assessment (SPA) with the FDA. KERX is preparing to begin a pivotal Phase 3 trial of perifosine in patients with mCRC and an additional SPA with the FDA for this indication is expected within the next three months. <o:p> </o:p> Below are some highlights from the GI-ASCO poster presentation: <o:p> </o:p> 1.) The improvements in TTP and OS with P-CAP compared to CAP are also seen in patients with 5-FU refractory disease. One patient with 5-FU refractory disease had a PR on P-CAP. <o:p> </o:p> 2.) P-CAP was well tolerated compared to CAP alone. <o:p> </o:p> <o:p> </o:p> 3.) A Phase I study to evaluate the combination of perifosine + capecitabine using a higher dose of capecitabine at 1000 mg/m2PO BID days 1 –14 is underway. PK of perifosine and capecitabine are being examined. <o:p> </o:p> <o:p> </o:p> 4.) Given the improved clinical efficacy of P-CAP compared to CAP in 5-FU refractory patients, a randomized Phase III study comparing P-CAP to CAP in patients with refractory mCRC is planned. <o:p> </o:p> Below is a summary of additional expected catalysts and milestones for KERX: <o:p> </o:p> On 12/16/09, KERX announced the initiation of a Phase 3 pivotal study of perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in multiple myeloma patients. It is structured as a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade) and dexamethasone and will enroll 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data. KERX expects a patient recruitment period of approximately 16-18 months and expects to report data from this study during 2H11. <o:p> </o:p> On 1/5/10, KERX announced that it has reached agreement with the FDA regarding a SPA on the design of a Phase 3 clinical program for Zerenex (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD). In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex will consist of two clinical studies, including (1) a short-term efficacy study that is expected to commence by the end of 1Q10 with date expected during 2H10; and (2) a long-term safety and efficacy study that is expected to begin mid-2010 with data expected and a NDA filing expected during 1H12. <o:p> </o:p> KERX also has a partnership in Japan with JT Torii that includes over $100 million in potential milestone payments. The ongoing Phase 2 study in Japan is near completion and KERX expects the Phase 3 trial to begin during 2H10, which will trigger a development milestone payment that is in the mid single digit million dollar range. An additional $15 million milestone is possible upon regulatory approval in Japan, with approximately $55 million in remaining milestone payments based on the achievement of sales targets upon commercialization. <o:p> </o:p> Disclosure: Long KERX
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January 17
Healthcare Conference Update: A New Strategy for ImmunoCellular (OTC: IMUC.OB)
This pick is about: Dendreon Corp (DNDN)
| Rating: |
$29.05 (01/17/10)
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| Gain/Loss: |
-85.44%
in
1247 days
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I had the opportunity last week to discuss the updated strategy and expected milestones for ImmunoCellular Therapeutics (OTC: IMUC.OB) in 2010 and beyond with CEO, Manish Singh, following the conclusion of the OneMed, JP Morgan, and other healthcare conferences in San Francisco. IMUC is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells, based on two technology platforms that include active (therapeutic cancer vaccines) and passive (monoclonal antibodies) approaches. <o:p> </o:p> The ProActive News Room website for IMUC contains an updated compilation of digital media coverage links, an embedded video of IMUC’s OneMed presentation last week, news feeds, market data, and report / presentation downloads that include research reports published by Griffin Securities for IMUC plus the cancer stem cell industry along with IMUC’s Oct. 2009 study update presentation for ICT-107. The reports and presentations are available to view / download in PDF format for more details and information on the science behind IMUC and the overall cancer stem cell approach to the disease. <o:p> </o:p> IMUC has adopted a new strategy for 2010, including plans to conduct a Phase 2b trial of ICT-107 as the best way to increase shareholder value based on the impressive Phase I survival data in brain cancer patients that was updated last fall. Previously, IMUC planned to seek a licensing deal for further development of ICT-107 while retaining ICT-121 for in-house development as an off-the-shelf therapeutic cancer vaccine that has not yet entered clinical trials. <o:p> </o:p> ICT?107 is an autologous (patient-derived) dendritic cell (DC) therapeutic cancer vaccine that has been evaluated in a Phase I clinical trial initiated in May 2007 with a goal of determining the safety and immune response of patients with glioblastoma multiforme (GBM is the most aggressive and common form of primary brain cancer). ICT-107 targets six cancer-specific peptide antigens (a multi-epitope cancer vaccine targeting the following: HER2, TRP-2, gp100, MAGE-1, IL13R alpha, and AIM-3), including targets that are highly expressed on cancer stem cells. <o:p> </o:p> ICT-107 will be evaluated in a randomized, controlled Phase 2b study (there is no need for a dose-ranging Phase 2a component in this study since dosing of ICT-107 is already established) that is structured to compare treatment groups receiving the standard of care (SOC) for GBM (radiation therapy plus temozolomide / Temodar) versus patients receiving SOC + ICT-107. This study is expected to begin during 2H10 with similar inclusion / exclusion criteria to the previous Phase I open-label study in patients with GBM. <o:p> </o:p> In addition, IMUC has recently initiated the process to obtain Orphan Drug status in the U.S. and Europe for ICT-107 for GBM and expects to file and obtain this designation during 1H10. Last October, IMUC presented new data for its therapeutic cancer vaccine product candidate ICT-107 that included a median PFS survival time in the 16 newly diagnosed patients enrolled in the trial of 19 months, which is over 12 months longer than the historical PFS of just 6.9 months. <o:p> </o:p> According to NCI/NIH statistics , approximately 19,000 people in the U.S. (plus a similar estimated incidence in Europe) are diagnosed with primary brain cancers each year, representing an unmet medical need that afflicts less than 200,000 people annually, which is the cut-off for Orphan Drug designation. <o:p> </o:p> If later stage clinical trials confirm the impressive Phase 1 brain cancer survival data, ICT-107 has the potential to emerge as a leading, next-generation DC-based therapeutic cancer vaccine because of an excellent safety profile and several unique features that are outlined below, which differentiate IMUC’s approach to cancer immunotherapy from that of Dendreon (NASDAQ: DNDN) and other companies in the space. <o:p> </o:p> 1.) multi-epitope (targeting epitopes / specific peptide regions of six tumor-associated antigens) rather than targeting a single cancer-related antigen that results in ICT-107 targeting BOTH cancer cells that comprise the bulk of tumors (daughter cells) AND the much less prevalent / residual cancer stem cell population thought to be responsible for the recurrence and spread of the disease; <o:p> </o:p> 2.) highly expressed cancer stem cell antigen components of ICT-107 are also present in other forms of the disease such as ovarian, pancreatic, and breast cancers plus melanoma (with a possible Phase I/II trial in ovarian cancer patients being initiated in 2011 since this would likely result in the shortest time frame to generate data); <o:p> </o:p> 3.) impressive early-stage, Phase 1 survival results for GBM that provides the rationale for the upcoming Phase 2b randomized / controlled study; and <o:p> </o:p> 4.) manufacturing benefits include the ability to produce 5-10 doses of ICT-107 from a single production run at an estimated cost of goods sold (COGS) of $15,000; <o:p> </o:p> 5.) favorable economics / business model based on a low COGS and a projected dosing regimen that includes an initial dose, followed by maintenance doses administered every 3-6 months for estimated revenue of $100,000 per patient treated each year; and <o:p> </o:p> 6.) R&D / formulation activities are underway to develop an off-the-shelf product based on the six cancer-specific peptide antigens present in ICT-107 combined with an immune system adjuvant (e.g. GM-CSF) with the goal of developing a sustained-release depot that is administered by subcutaneous injection and packaged in a single ready-to-use vial (with a Phase 1 study for this formulation possible by late 2010). <o:p> </o:p> IMUC is also developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, therapeutic cancer vaccine (ICT-121) which targets a protein marker called CD133 that is over-expressed on cancer stem cells. An IND filing / clearance with the FDA would be required prior to initiation of clinical studies, but IMUC is now shifting its focusing on the clinical stage development (Phase 2b) of ICT-107 rather than starting the entire clinical testing process over for ICT-121. <o:p> </o:p> In addition, IMUC previously acquired a platform technology to create cancer monoclonal antibodies (mAbs) based on a differential immune response (DIAAD) methodology. IMUC is developing cancer?specific mAb candidates targeting small cell lung cancer, pancreatic, ovarian, colon cancers and multiple myelomas. ICT?69 is being developed for multiple myeloma / ovarian cancer with a previously announced option license agreement with Roche (OTC: RHHBY.PK) that includes up to $32 million in payments and royalties. <o:p> </o:p> Last September, IMUC announced promising results from a pilot study evaluating the ability of the mAb (ICT-109) to distinguish between inflammatory conditions, cancerous, and non-cancerous tissue among pancreatic and lung cancer samples in the blood. ICT-109 was able to detect the pancreatic and lung cancer samples by binding to specific regions (glycosylated epitopes) of two common, over-expressed markers (CEA-CAM6 and CEA-CAM5) in a wide range of cancers. <o:p> </o:p> In addition, glycosylated CEA is over-expressed in patients with pancreatic / lung cancers and can be used to detect these cancers using a direct blood test. IMUC has guided for a potential partnering of ICT-109 during 2010 and will also continue to develop additional mAbs targeting cancer stem cells (CSCs). <o:p> </o:p> The combination of existing cash / equivalents ($1.4 million at year-end), a low cash burn rate (approximately $600,000 per quarter), and the previously announced $10 million financing commitment provides IMUC with adequate resources to fund operations / development over the next 2.5–3 years, including the new strategy to conduct a randomized / controlled Phase 2b trial of ICT-107 as the best way to increase shareholder value based on the impressive open-label Phase I survival data in brain cancer patients. <o:p> </o:p> IMUC is currently trading at 90 cents with a three-month average daily trading volume of 40,000 shares, which represent significant percentage increases for both metrics since I first wrote about the Company in early April 2009 while it was trading at 25 cents per share with an average daily trading volume below 5,000 shares. Despite these impressive gains, IMUC currently trades at a market cap of approximately $15 million with no debt – leaving plenty of room for upside gains if the Company successfully executes on its new strategy for advancing ICT-107 through Phase 2b clinical trials, with additional catalysts and news flow also expected from its monoclonal antibody technology platform and ICT-121. <o:p> </o:p> Disclosure: Long IMUC.OB
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January 12
Unilife Medical (UNIFF.PK) (UNI.AX) Poised for NASDAQ: UNIS Trading Debut
This pick is about: SanofiAventis (SNY)
| Rating: |
$40.55 (01/12/10)
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| Gain/Loss: |
+31.99%
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1252 days
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During the second week of January, Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) shareholders overwhelmingly voted in favor of the Company’s U.S. relocation. Unilife is now in the final stages of preparation for a NASDAQ: UNIS stock market trading debut, which is expected to occur by the end of February in conjunction with the Company’s re-domiciliation to Central Pennsylvania. Unilife is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injected medications, sharps safety devices for healthcare facilities, and contract manufacturing services. Unilife USA will replace Unilife Australia as the entity which is listed on the ASX. Unilife Australia shareholders will receive common stock or CHESS Depositary Interests (CDIs) in Unilife USA. The CDIs will trade on the ASX and are analogous to American Depository Receipts (ADRs), which represent ownership stakes in foreign companies that trade on U.S. financial exchanges. Unilife USA will trade on the NASDAQ with ticker ‘UNIS’ and six CDIs will be equivalent to one ordinary share in Unilife USA. Last December, Unilife announced the construction of a 165,000 square foot development that will house the Company’s new global headquarters and a commercial production facility at 250 Cross Farm Lane in York, PA. The new facility will also include a 54,000 square foot office space for administrative, marketing, research / development, and quality control. The first stage of the new manufacturing facility will include automated assembly lines with annual capacity of 360 million units per year for Unifill, in addition to other assembly lines for Unitract 1mL safety syringes and other medical device contract manufacturing systems. There is a built-in option and strategy to allow for future expansion, including an additional 100,000 square foot in connected production space that would provide Unifill manufacturing capacity of 1 billion syringes per year. The new facility is expected to be operational by late 2010 and is being developed on a 38 acre parcel of land at a projected cost of $26 million, which included favorable terms for Unilife in terms of acquiring the land and the project development / contractor expense because of the overall economic conditions in the region which make this situation a buyer’s market (construction costs are down an estimated 25-30% from two years ago). However, Unilife has contracted with Keystone Redevelopment Group and HSC Builders and Constructions Managers, which are top tier organizations that serve Fortune 500 companies for economic development projects and specialize in the construction of customized facilities for leading life science / healthcare companies, respectively. The projected timeline for construction of the new facility includes the following milestones: 1.) the completion of clean rooms for equipment installation and a temporary occupancy permit for manufacturing / warehouse by the end of October 2010; 2.) an unrestricted occupancy permits for manufacturing / warehouse and office space by the end of December 2010; 3.) transfer and consolidation of all US-based staff / manufacturing systems from Lewisberry facilities (approximately five miles apart) beginning in early 2011. In addition, the centralization of production activities within Central PA will reduce the Company's operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply its safety syringes to all of its anticipated customers while leveraging upon the Company's strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs. In late October, Unilife announced the acceptance of a US$5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County as part of the Company's relocation of its global headquarters and manufacturing facilities to Central PA. Unilife plans to finance development of the new facility from a combination of existing cash reserves ($9 million) and external financing ($17 million), which may include a commercial bank loan, government agencies, and / or other lending institutions. The Company estimates that it saved $2-3 million in upfront development costs and will save approximately $400,000 annually in estimated loan financing payments for the new facility compared to lease payments at the current facility. The following are some key milestones that Unilife expects to achieve during 2010: 1.) the commercial release of Unitract 1mL plastic safety syringes in early 2010; 2.) complete negotiations with Sanofi-Aventis (NYSE: SNY) by end of February for Unifill therapeutic class exclusivity; 3.) subject to the SEC declaring registration statement effective and NASDAQ approval for listing application, Unilife expects NASDAQ: UNIS trading to begin in mid-February 4.) complete the Unifill industrialization program by the end of 2010 (one year ahead of original plan) with initial production goal of 60 million units per year and a projected increases to approximately 150 million units annually by 2012; and 5.) agreement(s) are possible as early as mid-2010 with additional pharmaceutical companies for Unifill pre-filled syringes outside of the exclusive therapeutic categories that are pending final negotiations with SNY. More than 2 billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000) in the U.S. (enforced by OSHA) with Europe expected to follow with similar regulations by 2012 based on the model that is currently enforced in Germany. The Unitract product line-up includes plastic safety syringes as 1mL fixed-needle + 3mL and 5mL attachable needles while the Unifill product line-up includes a glass ready-to-fill solution with both fixed needle and attachable options for medications delivered by pre-filled syringes. A strong resistance to change and high barrier to entry exists for competitors in the medical device / safety syringe market because once supply contracts are agreed upon and products receive marketing clearance; there is little incentive to change components (e.g. a pre-filled syringe) since this would require a new approval process to certify the new components being utilized. The unique features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes are outlined below and the Company has a major advantage and pending customer in the form of SNY along with a strategic plan that targets companies with new products in development that are designed for delivery through pre-filled syringes. 1.) a passive needle retraction system that is activated inside the body 2.) healthcare providers / shot administrators control the speed of needle retraction 3.) auto-disabling prevents the re-use or tampering of used syringes The market opportunity for prefilled syringes includes over 50 medications (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including a projected 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features, adding to the manufacturing and shipping costs while significantly increasing the overall packaging size (i.e. Unifill reduces packaging volume for drug products by 60% without the need for ancillary safety instruments that must be attached / assembled as with standard prefilled syringes), resulting in both waste disposal and marketing issues. The key strategic business partner for Unilife is Sanofi-Aventis, which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company (Griffin Securities estimates that SNY purchases 40% of all pre-filled syringes on a global basis). This key partnership provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of initial commercial demand for Unifill in 2011 with an initial production target of 60 million units per year. In July, Unilife and SNY agreed to a five-year exclusive licensing agreement for Unifill. SNY is paying A$46M for the right to negotiate purchase of the Unifill RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class. While the therapeutic exclusivity agreement (expected by February) will not be disclosed to the public to protect Sanofi's R&D pipeline; blood thinners and vaccines are two major product segments for SNY that are obvious inclusions and agreements that are announced with other companies will provide this information over time. The industrialization program was originally intended to be completed by the end of 2011, but it is proceeding ahead of schedule so that both parties have agreed to bring its scheduled completion date forward to the end of 2010 (an entire year ahead of schedule). Unilife is scheduled to commence supply of Unifill RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system, and the design of this first line will also be used to develop a higher-volume automated assembly system scheduled to be completed by the end of 2011. Given the current foreign exchange ratio for the Australian / U.S. dollar, a share price of $1 for the ASX stock listing ‘UNI’ would correspond to roughly $5.50 per share for Unilife USA when it begins trading on the NASDAQ. The share price above $5 and NASDAQ listing will be key elements to increasing the Company’s U.S. shareholder base and attracting institutional investors. In addition, the strong commitment to building a new facility in Central PA and over-delivering on strategic objectives adds to the bullish case for Unilife in 2010 and beyond. <font> Click here for the ProActive News Room website for Unilife </font> , which includes an updated compilation of digital media coverage links for the Company such as a recent CNBC video interview with CEO Alan Shortall, research reports (including an update report published yesterday by Crystal Research Associates), corporate presentations, news feeds, market data, and more. Disclosure: No positions
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January 11
Waste2Energy (OTC: WTEZE.OB) Announces Contract in Italy
This pick is about: Covanta Holding Corp. (CVA)
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$19.36 (01/11/10)
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Waste2Energy, Inc. (OTC: WTEZE.OB) designs, builds and installs waste-to-energy (W2e) plants that generate a source of clean and renewable energy by converting biomass or other solid waste that typically heads to the landfill. Click here to visit W2e’s ProActive News Room website for report / presentation downloads, videos, news feeds, and other info. This morning, W2e announced that it has received a contract from TBF + Partners AG for a Preliminary Engineering Design Study (PEDS) for a waste-to-energy plant in Italy, and the Company’s UK subsidiary will perform preliminary design work and pricing for the project. <o:p> </o:p> W2e is the process of creating energy in the form of electricity or heat from the incineration of waste source and represents a form of energy recovery. Most W2e processes produce electricity directly through combustion or produce a combustible fuel such as methane, methanol, ethanol or synthetic fuels. Once processed, the energy by product is electricity (from heat) and steam (also from heat generated during processing. <o:p> </o:p> There is a growing need on a worldwide basis to shift away from the landfill model of waste disposal due to the unsustainable growth rates (landfill creep) combined with rapidly growing populations, urbanization, and limited real estate / land availability in densely populated cities. The initial market opportunity for Waste2Energy lies in Europe, which is an estimated 2-3 years ahead of the U.S. in terms of dealing with waste disposal in an environmentally friendly manner on a local basis. <o:p> </o:p> The landfill model is limited and nearing end of life cycle with little incentive for innovation due to high tipping fees from distant cities that may send their trash via rail / truck transport for remote disposal, resulting in the waste of energy for transport, expanding landfills, and the generation of greenhouse gas emissions. W2e offers a local, community-based solution for waste with useful by-products in the form of steam to generate electricity, clean water (desalinization), and local jobs while simultaneously solving the problem of waste disposal. <o:p> </o:p> Larger players in the space such as Covanta (NYSE: CVA) and Waste Management (NYSE: WM) (Wheelabrator subsidiary) are not focused on the highly customizable, small-scale installations that W2e plans to offer, providing a large market niche on a global basis that has the potential to become very profitable for W2e once it secures funding. Covanta estimates that 14% (37 million people) of municipal solid waste in the U.S. is processed at waste-to-energy facilities, which produces enough electricity for 2.8 million homes. In addition, waste-to-energy facilities are more widespread in Europe (where W2e will focus its initial efforts) and Covanta estimates a total of 600 such facilities worldwide. <o:p> </o:p> Based on some quick calculations and estimates, a small town / region such as where I live in Western Pennsylvania presents a significant opportunity for installing and implementing a local, community-based W2e solution for trash. For example, an independent trash hauler could save nearly $1 million in tipping fees (which represent a significant operating cost) with the potential for add-on revenue by charging 50% of landfill tipping fees to accept municipal waste from other local / regional independent trash haulers. <o:p> </o:p> In addition, at a level of 200 tons per day of municipal solid waste, approximately 6 MW (megawatt) of power could be generated from municipal solid waste on a daily basis that could be put back into the electric grid. This compares to approximately 2 MW of power on a daily basis from each of the Gamesa (OTC: GCTAF.PK) windmills that line the mountaintops in Western PA. <o:p> </o:p> However, since no W2e facilities are currently in operation in the continental U.S., many independent trash haulers and communities such as mine are currently unaware that such technology exists. The challenge going forward will be to get a pilot facility up and running in the mainland U.S. that can serve as a model for hundreds of communities and independent trash haulers across the country to begin implementing. <o:p> </o:p> W2e's units are currently used at a number of locations such as the Ronald Reagan Strategic Missile Base, Kwajalein Atoll for mixed and hazmat wastes, Husavik, Iceland-mixed municipal wastes, BP/ARCO - Alaska for drilling camp wastes, Pogo Gold Mine, Philippines for mining camp wastes, Cayman Islands - hospital wastes and Conoco-Philips for use in Alaskan drilling camp waste disposal. <o:p> </o:p> In addition, W2e designed, built, and installed a cBOS system in Scotland for Scotgen, which represents a $35 million facility that will officially open after commissioning and will continuously produce 6 MW of electric grid power from both unsorted municipal and hazardous waste sources as a three acre permitted site for cBOS that processes 180 metric tons per day. W2e’s two?stage process of gasification and then oxidation is inherently cleaner than most other thermal processes for the conversion of waste to energy and the systems meet EU standards, which are more stringed than the U.S. EPA standards for air quality. <o:p> </o:p> Other commercial opportunities lie in developing countries, desalinization for clean water, islands / cruise ship waste disposal, military camps, oil / gas exploration, metals / mining sites, and hospitals (this a near-term opportunity in the U.S. market). W2e offers a scalable, community-based solution that is customizable and easier to implement from the budgetary / financing perspective for local governments since it offers the flexibility to start out on a small scale. <o:p> </o:p> Disclosure: No positions
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December 23
Mentor Capital / QI, Cancer Vaccine Investing Update Report
This pick is about: Mentor Capital Inc. (MNTR)
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$0.0 (12/23/09)
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The <font> BioMedReports.com stock research download section </font> has been updated today to reflect my new 22-page PDF report and overview of Mentor Capital (OTC: MNTR.PK), Quantum Immunologics (QI) (privately held), and clinical / regulatory updates for several other companies in the cancer vaccine that are outlined below and summarized in the report. Mentor Capital is a public-traded, private equity firm that specializes in acquisitions. The Company provides passive equity funding and liquidity to smaller companies and owners by investing in select shelf IPOs, public, and private companies to provide public market access to owners of small private companies. In early July 2009, as the first of four steps leading to a potential merger and name change, MNTR.PK acquired a 20% ownership stake in the privately-held cancer vaccine company, QI. In mid-December, Mentor Capital announced plans to launch an actively managed <font> Cancer Immunotherapy (CI) Index </font> fund shortly after New Year's Day that will be based on the underlying Mentor Capital CI Index, which has gained 45% on an equal-weight basis since its inception on 7/10/09. MNTR.PK intends to invest a significant portion of the cash proceeds from the exercise of warrants which are currently outstanding on a stepped-price basis at $1, $3, $5, and $7 per share. The Company also announced that $1.2 million each in initial seed funding for the CI Index will be provided in approximately equal parts by Mentor Capital management, WellCap Partners (fund administrator) , and MNTR.PK Series C (previously at $5) warrant holders. Mentor Capital currently has about 900,000 shares outstanding and the Series C warrants were called last week at $0.65 (for a period of 45 days) to provide approximately one-third of the initial seed funding for the CI Index fund. QI's approach to cancer immunotherapy involves sensitizing the dendritic cells (which present foreign antigens to the immune system) from a patient's blood to educate and direct the immune system to attack malignant tumor cells in a targeted effort to eradicate or stabilize the disease. This integrated approach to the treatment, diagnosis, and monitoring of cancer is being developed to create novel, individualized products and services that offer a high rate of efficacy and minimal side effects by harnessing the innate power of the immune system in a targeted manner against the disease. Ø QI expects to complete enrollment of all 27 patients in the ongoing Phase I/II trial for metastatic breast cancer by the end of 1Q10, at which time preliminary data is expected from the initial cohort of patients that will be discussed with the FDA to design a pivotal, Phase IIb/III clinical trial that could begin in late 2010. Ø QI is the exclusive licensee of various patent rights in the U.S., Europe, and other countries for the use of OFA to diagnose, monitor, and treat multiple types of cancer. The OFA-iLRP patents are the by-product of 20 years and $30 million of research primarily funded by the National Institute of Health / National Cancer Institute. In addition, QI has filed two provisional patents related to OFA peptides, further expanding QI’s patent estate. Dendreon (NASDAQ: DNDN) follows a similar approach to QI, except that Dendreon is initially focused on the treatment of prostate cancer as it prepares to become a commercial-stage company with the possible early to mid 2010 launch of Provenge (sipuleucel-T). Provenge is derived from a patient's own immune system (dendritic cells, hence the name Dendreon) and is poised (upon FDA approval) to become the first of a new class of therapeutics called active cellular immunotherapies (ACI) which are also referred to as therapeutic cancer vaccines. In November 2009, Dendreon announced that it completed the submission of an amended Biologics License Application (BLA) for Provenge, seeking FDA approval for men with metastatic castrate-resistant prostate cancer (CRPC). The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment (SPA) with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. Provenge is currently available through several ongoing clinical trials, including OpenACT (an open label trial enrolling men with metastatic CRPC), ProACT, and NeoACT. In late April 2009, Dendreon announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011. On 11/20/09, the FDA accepted Dendreon’s amended BLA as a complete response and set a PDUFA action date of 5/1/10 for an expected FDA decision for Provenge. In mid-November, Oncothyreon (NASDAQ: ONTY) reported its quarterly results and provided a development pipeline update. Stimuvax (BLP25 liposome vaccine, L-BLP25) is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, which is a glycoprotein antigen widely expressed on common cancers, including lung cancer, breast cancer, prostate cancer and colorectal cancer. ONTY’s partner for the development of Stimuvax, Merck KGaA / Serono (OTC: MKGAY.PK), is actively enrolling patients in two global Phase 3 trials. Initiated in February 2007, START is a randomized, double-blind, placebo-controlled study in patients with documented unresectable stage III non-small cell lung cancer who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. NCT00409188 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of December 2010 for final data collection of the primary outcome measure with an estimated enrollment of 1,322 patients. STRIDE is a randomized, double-blind, placebo-controlled study in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer, initiated in June 2009 with a primary endpoint of progression-free survival (PFS). NCT00925548 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of September 2012 for final data collection of the primary outcome measure with an estimated enrollment of 909 patients. ONTY is also developing BGLP40 as a completely synthetic MUC1-based liposomal glycolipopeptide cancer vaccine for potential use in several cancer indications. The antigen incorporated in BGLP40 combines carbohydrate and peptide determinates in a multi-epitope vaccine that evokes both cell- and antibody-mediated immune responses against major cancer-associated targets expressed on adenocarcinomas. The vaccine also includes the fully synthetic PET-lipid A adjuvant which is proprietary to ONTY, which currently intends to substantially complete the pre-clinical development of BGLP40 in 2010, with the goal of initiating clinical development in 2011. Merck KGaA / Serono has a right of first negotiation with respect to the development or marketing of BGLP40. Celldex Therapeutics (NASDAQ: CLDX) is developing CDX-110 (PF-04948568) along with Pfizer (NYSE: PFE) as a cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). CDX-110 is currently being evaluated in a Phase 2 study (ACT III) of CDX-110 in patients with newly diagnosed GBM. NCT00458601 is the ClinicalTrials.gov entry for this study (last updated on 11/20/09) and April 2010 is the estimated date for data collection for the primary outcome of progression-free survival status at 5.5 months from the date of first dose. The estimated study completion date is Nov 2010. ImmunoCellular Therapeutics (IMUC.OB) is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, therapeutic cancer stem cell vaccine (ICT-121) that targets a protein marker called CD133 that is over-expressed on cancer stem cells. The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months. ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers. IND Filings for ICT?121 are expected for brain tumors in during 1Q10 while IND Filings for ICT?121 for pancreatic cancer are expected during 3Q10. In late October, IMUC presented new data for its therapeutic cancer vaccine product candidate ICT-107 as an update to preliminary data that was presented at ASCO 2009 in late May and included a median PFS survival time (defined as the time between surgical tumor removal and tumor recurrence) in the 16 newly diagnosed patients enrolled in the trial was 19 months, which is over 12 months longer than the historical PFS of just 6.9 months. In addition, seven of the 16 patients continue to show no signs of tumor recurrence while three of the patients have gone more than two years without disease progression. ICT-107 targets six glioma-specific peptides, including targets that are highly expressed on cancer stem cells and IMUC expects to sign a licensing deal to fund further clinical development of ICT-107 during 2010. In early October, Inovio Biomedical (AMEX: INO) announced interim safety / immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. The vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered. The vaccine is delivered using Inovio’s proprietary CELLECTRA intramuscular electroporation delivery device. Inovio expects to report interim data relating to safety and levels of immune responses (immunogenicity) from the second and third dose groups during 1H10 and plans to initiate a Phase 2 trial in late 2010. This Phase I clinical trial is designed to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer. This dose-escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose. Northwest Biotherapeutics (OTC: NWBO.OB ) is developing DCVax-Brain as a personalized therapeutic cancer vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax-Brain is comprised of a patient's own dendritic cells that have been activated to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells. The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells in order to activate the patient's dendritic cells, which are subsequently injected back into the patient under the skin in the upper arm. The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax-Brain an off-the-shelf product for that patient throughout the treatment period, following the initial collection, preparation, and manufacturing process. NCT00045968 is the ClinicalTrials.gov identifier for a Phase 2 study evaluating DCVax-Brain in GBM patients which currently has an estimated date of December 2011 for final data collection for the primary outcome measure. On 10/21/09, NWBO.OB reported that DCVax-Brain has begun a 240-patient Phase 2 clinical trial with 13 trial sites at medical centers across the U.S. and stated that the trial is not currently enrolling patients, but expects to resume doing so soon. In late October, MannKind Corp. (NASDAQ: MNKD) announced that results of two Phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for Phase 2 studies. MKC1106-MT is an active cancer immunotherapy product candidate consisting of three components, a DNA plasmid and two synthetic peptides, each of which is administered separately by the unique route of intranodal injection and together are designed to target two tumor-specific antigens that are commonly expressed by melanoma tumor cells. Findings reveal an immune response rate of greater than 40%, defined as the percentage of patients who showed elevated numbers of antigen specific T cells in the blood upon immunization, and preliminary evidence of clinical benefit. Of the 18 patients treated, 14 had visceral metastases and the remaining four had metastases confined to the lymphatic system. MKC1106-PP is a similar agent being developed by MNKD that is designed to target two specific tumor antigens commonly expressed by various solid tumor cells. An immune response rate of 60% was observed and, of the 26 patients treated, seven patients achieved clinical responses defined as partial response (RECIST), change in PSA doubling time or stable disease for at least six months. In late October, Antigenics (NASDAQ: AGEN) announced updated Phase 2 data for Oncophage (vitespen) for recurrent high grade glioma (brain cancer) for the first 20 patients treated, demonstrating a median survival of 10.1 months. Survival data continues to accrue on all patients in the study and thus far, six patients (30%) have survived at or beyond 12 months. The Phase 2 single-arm trial is designed to enroll about 50 patients with recurrent high-grade glioma. Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines and then receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. The Brain Tumor Research Center at the University of California, San Francisco (UCSF), has initiated an additional Phase 2 clinical trial of Oncophage in combination with the standard of care (radiation + Temodar) for newly diagnosed glioma patients to evaluate median overall survival, progression-free survival and immune response. CEL-SCI Corp. (AMEX: CVM) is awaiting validation of its cold fill contract manufacturing facility (which will also manufacture Multikine) before initiating a pivotal Phase 3 clinical trial of Multikine. The pivotal Phase 3 study is designed as an open-label, randomized, global multi-center trial to evaluate the effects of Multikine plus standard of care (SOC) therapy (surgery + radiation or surgery + concurrent chemo / radiation) in subjects with advanced primary squamous cell carcinoma of the oral cavity versus the SOC therapy only. The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to SOC as measured by overall survival with secondary objectives that include evaluating the effects of Multikine on the cumulative incidence of local / regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, and confirming safety of the treatment. About 800 patients are expected to be enrolled in the study on a global basis that includes North / South America, Europe, and Asia. In late May, Biovest (OTC: BVTI.PK) announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase 3 clinical study has shown that BiovaxID (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin’s lymphoma. The study found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of 47%. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. In late June, Biovest announced that BiovaxID is available on a named-patient (compassionate-use) basis in Europe and will be supplied by Idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin’s lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Omnimmune (OTC: OMMH.OB) has licensed rights to platform monoclonal antibody (MAb) technologies and a multivalent cancer vaccine targeting two epitopes of HER-2 (Human Epidermal Growth Factor Receptor-2) (HER-2 is found in about 15-20% of breast cancers and is associated with increased disease recurrence and a worse prognosis). The cancer vaccine has completed a Phase 1 NCI-sponsored clinical trial. Omnimmune plans to sponsor Phase 2 and 3 trials and market the vaccine in collaboration with others. Omnimmune plans to develop prophylactic and therapeutic vaccines, monoclonal antibodies, and gene-based products, which target a hormone called human chorionic gonadotropin (hCG). On 12/9/09, Immunovaccine (TVE: IMV.V) announced FDA clearance for its Investigational New Drug (IND) application to begin human studies of its therapeutic cancer vaccine (DPX-0907). DPX-0907 is the Company’s lead therapeutic cancer vaccine candidate which uses the DepoVax platform to deliver tumor specific antigens. DPX-0907 is designed to cause a depot effect that has the potential to stimulate the immune system to seek out and destroy cancer cells in patients with breast, ovarian and prostate cancer. The Phase 1 clinical trial for DPX-0907 will be conducted at five sites in the US and is on track to begin enrolling patients with breast, ovarian, and prostate cancers by the end of 1Q10. The Phase 1 clinical trial will evaluate the safety and tolerability of the DepoVax delivery system and seven tumor-associated antigens. The activity of DPX-0907 has been demonstrated in preclinical models whereby the vaccine produced a specific cellular immune response that was superior to immune responses achieved with other oil depot vaccines. Preclinical research also reveals DPX-0907 does not induce regulatory T-cell immune suppression, therefore enabling a longer lasting anti-tumor immune response. Disclosure: Long CLDX, IMUC.OB, MNTR.PK, QI
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December 16
New Era Begins for NeoStem (AMEX: NBS) Following China Acquisition
This pick is about: Neostem Inc. (NBS)
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$1.6 (12/16/09)
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-66.25%
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<font> NeoStem (AMEX: NBS) </font> [click on preceding link for the Company’ s News Room website] is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications that is expanding into research, medical tourism, and China for the commercialization of regenerative medicine and other stem cell applicatons. In late October, NeoStem completed its acquisition of China Biopharmaceuticals, which resulted in a controlling 51% interest in Suzhou Erye Pharmaceuticals (Erye) and established three business segments for the Company (US + China stem cells and China pharmaceuticals focused on antibiotics and active pharmaceutical ingredients). 1.) NeoStem (US) includes an exclusive worldwide license to VSELs, a strong IP sourcing network for innovative stem cell / pharmaceutical products and AMEX listing for the stock in addition to its position in the domestic market as a leading adult stem cell banking network. 2.) Erye is a high-growth pharmaceutical manufacturer in China with a strong core business / profitable revenue base amidst booming demand and growth in the Chinese market. 3.) NeoStem (China) has strong support from the Chinese government for commercialization of cosmetic / regenerative medicine applications which will also expedite the process of US development as the Company becomes a vertically integrated stem cell operation in a permissive regulatory environment that includes strong government support. NeoStem plans to leverage the R&D conducted in China to fast-track the U.S. FDA approval process. Erye is a China-based pharmaceutical company that is expected to record revenue exceeding US$60 million in 2009. Since closing the merger, the market cap of NeoStem has more than tripled to about $60 million, which reflects additional shares of common stock issued as part of the merger and also approximates the projected revenue for Erye during 2009. Erye is a vertically integrated bio-pharmaceutical company in China focused on intermediate API / antibiotics which also includes a R&D team focused on drug discovery, improving existing drugs, and traditional Chinese medicine products plus a strong distribution network covering 30 provinces in China. The Company currently has 7 SFDA approved / certified production lines that are compliant with China GMP standards and is also in the process of a three-year expansion / relocation program that is expected to be completed by 2011. NeoStem has embarked upon several stem cell initiatives in China this year, including the creation of a separate stem cell operation in China, the construction of a stem cell R&D facility in Beijing, the establishment of relationships with hospitals to provide stem cell therapies, and the licensing of stem cell therapeutics focused on regenerative medicine applications. During 2010, NeoStem plans to begin offering stem cell banking services and therapies in China, in addition to medical tourism initiatives that will offer these services to those living in developed countries such as the US where such treatments are either unavailable or unaffordable. In addition, the current network of US adult stem cell banking facilities is focused on Southern California and the Northeast region with a goal of expanding coverage to include 10 markets by the end of 2010. NeoStem has also expanded into stem cell research as part of an exclusive licensing agreement with the University of Louisville for the identification and isolation of rare stem cells found in adult bone marrow called VSEL for short (very small embryonic-like). As the name suggests, VSELs share traits with embryonic stem cells (ESCs), including the ability to differentiate into a wide variety of cells (pluripotency) found throughout the body for many potential medical applications. NBS China plans to maximize its pre-therapeutic / R&D revenue by the supply of VSELs for clinical trials in China which will be provided exclusively through its subsidiary, Beijing RuiJieAo. NeoStem will also exploit the easier regulatory path to commercialization in China for near-term revenue potential while leveraging mature therapies / technology from NeoStem’s extensive U.S. network and collaboration agreements. NeoStem is targeting the introduction of highly mature U.S.-based therapies that lack FDA approval which is necessary for widespread use in the domestic market. NBS China intends to commercialize its first stem cell therapy for orthopedic indications in 2009 while developing a pipeline of additional therapies for CNS (central nervous system) disease, wound healing, and heart disease. The initial orthopedic market will target 80-100 million arthritis sufferers in China, while future applications will be aimed at over 25 million individuals with long-term CNS conditions and heart disease (the third largest killer in China with 1.5 million deaths per year). NeoStem will also offer medical tourism service centers to serve patients from affluent countries that have more restrictive regulatory processes such as US and Europe. The Company’s medical tourism initiatives in China will offer world class SOPs (standard operating procedures), standards of care, and facilities. An estimated 7,000 patients have been treated in China’s medical tourism industry since 2001, but current offerings lack the rigorous SOPs / facilities and do not include the world class standard of care that NeoStem can offer. NBS China will coordinate the launch of anti-aging / cosmetic medicine applications with its major principal in China while simultaneously launching its legacy adult stem cell banking business. A strong pipeline of innovative stem cell based therapies has been sourced from the Company’s network of partners in the U.S. NeoStem has assembled an experienced team of executives and scientific / medical advisors to implement its strategy in China to best capitalize on the opportunity, which includes both a rapidly growing middle class in China with increased spending power and a medical tourism business for those located outside of China. Disclosure: No positions.
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December 13
Unilife Medical (ASX: UNI.AX) (UNIFF.PK): Recent Sell-Off Unwarranted, Quick Rebound Likely
This pick is about: Unilife Medical Solutions Ltd (UNIFF)
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$0.0 (12/13/09)
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Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing services. Last Thursday afternoon, a large block of stock (over 1 million shares) hit the tape, sending Unilife’s primary ASX stock listing from around $1 to 87 cents before recovering about half of this loss and settling back to the mid 90 cent range. While there is no fundamental reason for the initial 13% plunge given all of the positive developments at the Company, a large holder of Unilife’s stock apparently had another, unrelated reason to unload the stock before year-end ahead of the holidays and expected slowdown in trading volume from the current average of about 1.5 million shares per day on the ASX. The following are some key milestones that Unilife expects to achieve over the next year: 1.) the commercial release of Unitract 1mL plastic safety syringes in early 2010; 2.) complete negotiations with Sanofi-Aventis (NYSE: SNY) by end of February for Unifill therapeutic class exclusivity; 3.) redomiciliation to the U.S. (Central Pennsylvania) and NASDAQ stock listing (ticker will be UNIS) expected by end of February; 4.) complete the Unifill industrialization program by the end of 2010 (one year ahead of original plan) with initial production goal of 60 million units per year and projected increases to approximately 150 million units annually by 2012, and over 400 million units annually by 2014 and beyond; and 5.) agreement(s) are possible as early as mid-2010 with additional pharmaceutical companies for Unifill pre-filled syringes outside of the exclusive therapeutic categories agreed upon with SNY. More than 2 billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000) in the U.S. (enforced by OSHA) with Europe expected to follow with similar regulations by 2012 based on the model that is currently enforced in Germany. The Unitract product line-up includes plastic safety syringes as 1mL fixed-needle + 3mL and 5mL attachable needles while the Unifill product line-up includes a glass ready-to-fill solution with both fixed needle and attachable options for medications delivered by pre-filled syringes. A strong resistance to change and high barrier to entry exists for competitors in the medical device / safety syringe market because once supply contracts are agreed upon and products receive marketing clearance; there is little incentive to change components (e.g. a pre-filled syringe) since this would require a new approval process to certify the new components being utilized. The unique features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes are outlined below and the Company has a major advantage and pending customer in the form of SNY along with a strategic plan that targets companies with new products in development that are designed for delivery through pre-filled syringes. 1.) a passive needle retraction system that is activated inside the body 2.) healthcare providers / shot administrators control the speed of needle retraction 3.) auto-disabling prevents the re-use or tampering of used syringes The market opportunity for prefilled syringes includes over 50 medications (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including a projected 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features, adding to the manufacturing and shipping costs while significantly increasing the overall packaging size (i.e. Unifill reduces packaging volume for drug products by 60% without the need for ancillary safety instruments that must be attached / assembled as with standard prefilled syringes), resulting in both waste disposal and marketing issues. In mid-August, Unilife announced that it has commenced U.S. production of the Unitract 1mL Insulin Syringe at its FDA-registered manufacturing facility in Pennsylvania. The Company's automated assembly system is now rated at up to 90% of efficiency and Unilife will continue to work towards achieving the optimum productivity rate for this assembly system of about 40 million units per year. Unilife is building inventory to fulfill current and anticipated orders for the Unitract 1mL Syringes, which has already received key regulatory certifications for use in major markets such as the U.S., Canada, Europe, and Australia. The Company's strategic partner for exclusive manufacturing and distribution of sharps safety products is Shanghai Kindly Enterprise Development Group (KDL). This facility currently produces Unitract 1mL syringes and blood collection safety devices using semi-automated assembly systems developed and qualified by Unilife. KDL is the second largest medical device manufacturer in China and has two-thirds market share of the Chinese needle market, manufacturing over 5 billion needles and 600 million syringes per year while serving as a key partner for the Asia-Pacific region. The key strategic business partner for Unilife is Sanofi-Aventis, which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company (Griffin Securities estimates that SNY purchases 40% of all pre-filled syringes on a global basis). This key partnership provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of initial commercial demand for Unifill in 2011 with an initial production target of 60 million units per year. In July, Unilife and SNY agreed to a five-year exclusive licensing agreement for Unifill. SNY is paying A$46M for the right to negotiate purchase of the Unifill RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class. While the therapeutic exclusivity agreement (expected by February) will not be disclosed to the public to protect Sanofi’s R&D pipeline; blood thinners and vaccines are two major product segments for SNY that are obvious inclusions and agreements that are announced with other companies will provide this information over time. The industrialization program was originally intended to be completed by the end of 2011, but it is proceeding ahead of schedule so that both parties have agreed to bring its scheduled completion date forward to the end of 2010 (an entire year ahead of schedule). Unilife is scheduled to commence supply of Unifill RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system, and the design of this first line will also be used to develop a higher-volume automated assembly system scheduled to be completed by the end of 2011. In November, Unilife announced the appointment of Mikron Group as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill ready-to-fill syringe. This high-volume automated assembly system is anticipated to have an annual production capacity greater than 100 million units and Unilife has a target production plan for the RTFS of about 400 million units per year beyond 2014. Mikron was chosen after an extensive due diligence process by Unilife that began with the evaluation of 30 automated assembly partner candidates. The initial list was narrowed down to five suppliers that were each visited and asked to submit proof of principle samples for their high-volume, automated manufacturing systems before Mikron was ultimately chosen by Unilife. The high-volume manufacturing system is scheduled for delivery by October 2010 as part of finalizing the industrialization agreement between Unilife and SNY that is targeted for the end of next year. In addition, the centralization of RTFS production activities within Central PA will reduce the Company's operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply the RTFS to all of its anticipated customers while leveraging the Company's strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs. In late October, Unilife announced the acceptance of a US$5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County as part of the Company’s relocation of its global headquarters and manufacturing facilities to Central PA. In late October Unilife also announced that CEO Alan Shortall purchased 479,800 shares of the Company's stock on the open market at an average price of A$1.026 per share and the CEO has authorized his broker to purchase additional shares that will bring the total number of shares purchased to over 500,000. Mr. Shortall commented that he elected to purchase the shares in the open market rather than participate in the Company's private placement from earlier in the month (conducted at a 7.7% discount to the market price at the time) as a sign of confidence to shareholders by purchasing at regular market prices. Unilife announced a A$42.1M capital raise to accelerate the expansion of its operational capabilities, production facilities, and equipment requirements in the U.S., in addition to completing the industrialization program for Unifill. Unilife also plans to expedite the commercialization of additional pipeline products with other interested major pharmaceutical companies with whom the Company is currently in discussions. Finally, the proceeds of the capital raise will ensure adequate cash reserves leading to the U.S. relocation and planned NASDAQ listing for the stock. The expected NASDAQ primary stock listing by February as ticker ‘UNIS’ is not a capital raising event as Unilife already enjoys a strong balance sheet with A$55.7 million in cash and additional sources of revenue such as pending milestone payments from SNY, commercial release of Unitract syringes, and the pending sale of Unifill to SNY starting in 2011. Unilife has been listed on the Australian Stock Exchange (ASX) since 2002 with approximately 310 million shares outstanding and 8,000 shareholders at this time. A shareholder meeting and vote will be conducted on 1/8/10 to approve a proposed transaction whereby Unilife USA will replace Unilife Australia as the entity which is listed on the ASX. Unilife Australia shareholders will receive common stock or CHESS Depositary Interests (CDIs) in Unilife USA. The CDIs will trade on ASX and are analogous to American Depository Receipts (ADRs), which represent ownership stakes in foreign companies that trade on U.S. financial exchanges. Unilife USA will seek a NASDAQ listing under ticker ‘UNIS’ and six CDIs will be equivalent to one ordinary share in Unilife USA. Given the current foreign exchange ratio of approximately A$1 to US$0.91, a share price of $1 for the ASX stock listing would translate into $5.46 per share for Unilife USA when it begins trading on the NASDAQ (= $1 share price for CDIs on ASX * 6 * 0.91 for-ex ratio). Disclosure: No positions
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November 26
BioMed Research Reports: Clinical Data (NASDAQ: CLDA), Lpath (OTC: LPTN.OB)
This pick is about: Clinical Data Inc (CLDA)
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$15.96 (11/26/09)
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The BioMedReports.com research download section has been updated to include PDFs for two recent research reports written by Griffin Securities for Clinical Data (NASDAQ: CLDA) and Lpath, Inc. (OTC: LPTN.OB). Lpath received a buy rating with a $5 per share 12-month price target while CLDA was rated a buy with a 12-month price target of $38 per share. Below is a summary of both companies from their respective reports. Lpath, Inc. is a biotechnology company focused on lipidomics-based therapeutics that target bioactive signaling lipids for treating a wide range of human disease and is the only company to have developed monoclonal antibodies against bioactive lipids. The Company is currently advancing three early-stage (poised to enter Phase 2 clinical studies) drug candidates (ASONEP TM ; iSONEP TM ; and Lpathomab TM ) in addition to a drug-discovery platform known as ImmuneY2 TM which Lpath is leveraging to further expand its pipeline. In early June, Clinical Data announced positive top-line results from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase 3 trial. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the FDA for vilazodone for the treatment of MDD during 1Q10. CLDA is also evaluating Stedivaze (apadenoson) in an ongoing Phase 3 clinical trial as a cardiac stress imaging agent. Stedivaze is used to identify the symptoms of coronary artery disease (CAD) with patent protection through 2027 and estimated peak sales potential of $523 million. On 11/18/09, CLDA announced the start of the Phase 3 trial of Stedivaze, which is a selective A2A receptor agonist, in development for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) scans (aka cardiac stress tests), which are used to identify symptoms of CAD. Stedivaze is a highly selective, high affinity agonist of the adenosine A2A receptor. The initiation of the trial followed a meeting with the FDA that reviewed Phase 2 data showing a rapid onset and offset of action following bolus dosing and improved tolerability over marketed products, such as Adenoscan (adenosine) by Astellas Pharma. The trial is expected to enroll approximately 750 patients over an 18-24 month period with an estimated date of 11/30/11 to complete this process. The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Disclosure: No positions.
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November 24
Under the Radar Healthcare Stocks: Protox, Pressure BioSciences, Unilife
This pick is about: Pressure BioSciences Inc. (PBIO)
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$1.675 (11/24/09)
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-81.49%
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Below are three under the radar stocks from the healthcare sector that I have been following for the past 3-6 months which have upcoming catalysts in the form of expected strategic deals, clinical trial results, and other corporate developments. Click here to check out my <font> kaChing.com virtual investing portfolio </font> , strategy, long / short virtual stock picks, and statistics since I started using the site in mid-April. <font> Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) </font> (click on preceding link for the Company’s ProActive News Room landing page) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. The Company's clinical-stage pipeline is based on the PORxin and INxin technology platforms. Lead drugs in clinical development include PRX302 for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate) and localized prostate cancer as well as PRX321 for primary brain cancer (glioblastoma multiforme / GBM and astrocytoma). In early September 2009, Protox announced that it completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study. The Company expects to report top-line results from the TRIUMPH study during late 2009 or early 2010. PRX302 is the lead drug in the company's PORxin technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death. <font> Pressure BioSciences (NASDAQ: PBIO) </font> (click on preceding link for the Company’s ProActive News Room landing page) is a life science research tools company that is commercializing and developing its innovative core technology platform known as pressure cycling technology (PCT). PCT uses cycles of hydrostatic (water-based) pressure between ambient and ultra-high levels (up to 45,000 PSI) at controlled temperatures to rapidly and repeatedly control interactions at the molecular level. The Company sells and installs pressure-generating instruments (Barocyclers), and its internally developed consumables product line includes PULSE (Pressure Used to Lyse Samples for Extraction) Tubes as well as application specific kits which include consumable products and reagents (ProteoSolve kits) which together make up the PCT Sample Preparation System. In mid-November, PBIO announced 3Q09 results, which included a record number of Barocycler instrument installations (20 versus 17 in the year-ago period), revenue of $317,427 (+19% from the year-ago period), an operating loss of $754,180 (reduced 32% from the year-ago period), and cash burn for the quarter of approximately $597,000 (down 39% from the year-ago period). Last week, PBIO announced that it received over $1.1 million from an initial tranche of a $2.5 million private placement after closing 3Q09 with approximately $1.4 million in cash / equivalents and 2.2 million shares of common stock outstanding. In addition, PBIO expects to announce a strategic marketing / distribution agreement with at least one large, multi-national life sciences company in late 2009 or early 2010, following a previously announced deal in mid-October with Protein Forest, Inc. that is designed to increase market share / sales, partner on new product development, and and achieve co-marketing synergies due to the common end-market shared by the companies that includes research labs utilizing mass spectrometry for biomarker analysis. <font> Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) </font> (click on preceding link for the Company’s ProActive News Room landing page) is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices. More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000). Key differentiating features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes include the following: 1.) a passive needle retraction system that is activated inside the body 2.) healthcare providers / shot administrators control the speed of needle retraction 3.) auto-disabling prevents re-use or tampering with used syringes. The market opportunity for prefilled syringes includes 50 drugs (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including an estimated 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features - which adds to production / shipping costs and increases the overall packaging size by up to 60%, resulting in both waste disposal and marketing issues. Unilife is targeting initial annual commercial production of about 60 million units of the Unifill syringe with development expected to begin next month for installation in the Company's Central Pennsylvania manufacturing facility slated for 4Q10 in conjunction with industrialization partner Sanofi-Aventis (NYSE: SNY), which is a major customer for safety syringes to deliver injectable products such as the flu vaccine and blood thinner Lovenox. Earlier this month, Unilife announced the filing of an Information Memorandum with respect to its proposed relocation to the US and primary stock listing on the NASDAQ with a shareholder meeting / vote scheduled for 2010. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my <font> 23 ProActive HavRx stock indexes </font> . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes. The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Disclosure: Long PTXRF.PK
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November 23
BioMed News Bytes: Transcept, SciClone, ProUroCare, ABIO
This pick is about: Prourocare Medical Inc. (PUMD)
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$0.0 (11/23/09)
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n/a
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On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects. Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo NDA resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million. On 11/23/09, ProUroCare (OTC: PUMD.OB) announced that a 510(k) submission for U.S. market clearance of a prostate mechanical imaging system has been filed with the FDA, seeking a labeling claim for the device as an aid to visualize and document abnormalities of the prostate detected and/or monitored by digital rectal examination (DRE). The system incorporates the company’s unique and patented tactile elasticity imaging technology that creates a “map” of the prostate and an electronic record that can be stored for future analysis. On 10/8/09, announced the completion of a National Institute of Health and National Cancer Institute-supported clinical study. The study's purpose was to evaluate the ability of the company's ProUroScan imaging system to visualize and document abnormalities in the prostate detected or monitored by the DRE. The ProUroScan imaging system is designed to complement the DRE, and to provide patients with potential prostate abnormalities the ability to have their prostates imaged in real time with records electronically stored for later comparison. On 11/23/09, SciClone Pharma (NASDAQ: SCLN) announced that patient enrollment is complete ahead of schedule for its Phase 2 trial of SCV-07, which is a small molecule synthetic peptide with immune-modulating properties, for the treatment of severe oral mucositis (OM) in patients with head and neck cancer. Top-line results of the oral mucositis trial are expected to be announced during 1H10. The multi-center, randomized, double-blind, placebo-controlled, dose ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of OM in patients receiving standard chemo-radiation therapy for treatment of cancers of the head and neck. SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. On 11/23/09, ARCA biopharma (NASDAQ: ABIO) announced that the FDA has designated as a Fast Track development program the investigation of Gencaro, the Company’s experimental, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. Last week, ABIO stated that it intends to submit a study protocol during 4Q09 for review under the FDA’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. ARCA anticipates that the proposed trial protocol will be a superiority comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. Subject to the timing and outcome of the Agency’s review of the SPA submission, and subject to the Company’s ability to obtain sufficient funding, the Company currently expects it could begin the proposed trial in late 2010 or 1H11. On 6/1/09, ABIO announced that it received a CRL from the FDA for the Gencaro NDA for the treatment of patients with chronic heart failure. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my <font> 23 ProActive HavRx stock indexes </font> . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes. The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Disclosure: No positions
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BioMed News Bytes: Transcept, SciClone, ProUroCare, ABIO
This pick is about: SciClone Pharmaceuticals Inc. (SCLN)
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$2.59 (11/23/09)
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+89.19%
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1302 days
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On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects. Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo NDA resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million. On 11/23/09, ProUroCare (OTC: PUMD.OB) announced that a 510(k) submission for U.S. market clearance of a prostate mechanical imaging system has been filed with the FDA, seeking a labeling claim for the device as an aid to visualize and document abnormalities of the prostate detected and/or monitored by digital rectal examination (DRE). The system incorporates the company’s unique and patented tactile elasticity imaging technology that creates a “map” of the prostate and an electronic record that can be stored for future analysis. On 10/8/09, announced the completion of a National Institute of Health and National Cancer Institute-supported clinical study. The study's purpose was to evaluate the ability of the company's ProUroScan imaging system to visualize and document abnormalities in the prostate detected or monitored by the DRE. The ProUroScan imaging system is designed to complement the DRE, and to provide patients with potential prostate abnormalities the ability to have their prostates imaged in real time with records electronically stored for later comparison. On 11/23/09, SciClone Pharma (NASDAQ: SCLN) announced that patient enrollment is complete ahead of schedule for its Phase 2 trial of SCV-07, which is a small molecule synthetic peptide with immune-modulating properties, for the treatment of severe oral mucositis (OM) in patients with head and neck cancer. Top-line results of the oral mucositis trial are expected to be announced during 1H10. The multi-center, randomized, double-blind, placebo-controlled, dose ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of OM in patients receiving standard chemo-radiation therapy for treatment of cancers of the head and neck. SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. On 11/23/09, ARCA biopharma (NASDAQ: ABIO) announced that the FDA has designated as a Fast Track development program the investigation of Gencaro, the Company’s experimental, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. Last week, ABIO stated that it intends to submit a study protocol during 4Q09 for review under the FDA’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. ARCA anticipates that the proposed trial protocol will be a superiority comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. Subject to the timing and outcome of the Agency’s review of the SPA submission, and subject to the Company’s ability to obtain sufficient funding, the Company currently expects it could begin the proposed trial in late 2010 or 1H11. On 6/1/09, ABIO announced that it received a CRL from the FDA for the Gencaro NDA for the treatment of patients with chronic heart failure. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my <font> 23 ProActive HavRx stock indexes </font> . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes. The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Disclosure: No positions
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BioMed News Bytes: Transcept, SciClone, ProUroCare, ABIO
This pick is about: Transcept Pharmaceuticals Inc. (TSPT)
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$5.21 (11/23/09)
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+42.99%
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1302 days
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On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects. Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo NDA resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million. On 11/23/09, ProUroCare (OTC: PUMD.OB) announced that a 510(k) submission for U.S. market clearance of a prostate mechanical imaging system has been filed with the FDA, seeking a labeling claim for the device as an aid to visualize and document abnormalities of the prostate detected and/or monitored by digital rectal examination (DRE). The system incorporates the company’s unique and patented tactile elasticity imaging technology that creates a “map” of the prostate and an electronic record that can be stored for future analysis. On 10/8/09, announced the completion of a National Institute of Health and National Cancer Institute-supported clinical study. The study's purpose was to evaluate the ability of the company's ProUroScan imaging system to visualize and document abnormalities in the prostate detected or monitored by the DRE. The ProUroScan imaging system is designed to complement the DRE, and to provide patients with potential prostate abnormalities the ability to have their prostates imaged in real time with records electronically stored for later comparison. On 11/23/09, SciClone Pharma (NASDAQ: SCLN) announced that patient enrollment is complete ahead of schedule for its Phase 2 trial of SCV-07, which is a small molecule synthetic peptide with immune-modulating properties, for the treatment of severe oral mucositis (OM) in patients with head and neck cancer. Top-line results of the oral mucositis trial are expected to be announced during 1H10. The multi-center, randomized, double-blind, placebo-controlled, dose ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of OM in patients receiving standard chemo-radiation therapy for treatment of cancers of the head and neck. SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. On 11/23/09, ARCA biopharma (NASDAQ: ABIO) announced that the FDA has designated as a Fast Track development program the investigation of Gencaro, the Company’s experimental, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. Last week, ABIO stated that it intends to submit a study protocol during 4Q09 for review under the FDA’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. ARCA anticipates that the proposed trial protocol will be a superiority comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. Subject to the timing and outcome of the Agency’s review of the SPA submission, and subject to the Company’s ability to obtain sufficient funding, the Company currently expects it could begin the proposed trial in late 2010 or 1H11. On 6/1/09, ABIO announced that it received a CRL from the FDA for the Gencaro NDA for the treatment of patients with chronic heart failure. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my <font> 23 ProActive HavRx stock indexes </font> . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes. The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Disclosure: No positions
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November 22
Diabetes Care: Global Investing Opportunities
This pick is about: NovoNordisk A/S (NVO)
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$66.15 (11/22/09)
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+153.59%
in
1303 days
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The <font> American Diabetes Association estimates </font> that there are currently 23.6 million diabetics in the U.S. (7.8% of the total population, including 17.9 million diagnosed cases, 5.7 million undiagnosed, and 57 million pre-diabetics. Diabetes results in an estimated $174 billion in costs from diagnosed cases of diabetes in the U.S. (2007). On a global scale, the <font> International Diabetes Federation (IDF) estimates </font> 285 million diabetics worldwide in 2010. I have outlined some investing opportunities in this article, with a focus on emerging small / micro-cap companies from across the world which are developing innovative therapeutics, diagnostics, and monitoring products to improve the treatment outcomes for the growing, global diabetes epidemic. Epinex Diagnostics, Inc. (privately held) is dedicated to the development of innovative point-of-care technologies using rapid diagnostic tests. Epinex has developed a proprietary platform for rapid tests that apply existing immunoassay strips and biosensors to create unique quantitative diagnostic tests, focused on a significant initial market opportunity for a new type of diabetes monitoring test that measures glycated albumin (G1a), with an expected FDA 510(k) filing in early 2010 seeking marketing clearance as a Class 2 medical device for an expected review period of 90 days. My 13-page profile report and the most recent corporate profile for Epinex are available to view or download at the <font> BioMedReports.com research downloads section </font> or at the <font> ProActive News Room landing page for Epinex </font> . Novo Nordisk (NYSE: NVO) is based in Denmark and represents the largest (market cap of US$39.5 billion), globally diversified play on diabetes care, deriving over 73% of total revenue (US$5.6 million / US$7.6 million) during the first nine months of 2009 from this business segment. During the first three quarters of 2009, NVO posed total and diabetes care segment sales growth of 15% (Danish kroner) and 11% (local currencies). NVO expects to receive formal feedback from the FDA during 4Q09 for its pending Victoza (liraglutide is a once-daily human GLP-1 analogue) New Drug Application (NDA) seeking U.S. marketing approval for the treatment of type 2 diabetes in adults. In early July, the European Commission granted marketing authorization for liraglutide. Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. Another company awaiting a FDA decision for a new diabetes care product is MannKind Corp. (NASDAQ: MNKD), which submitted its NDA in mid-March that is seeking FDA approval of Afresa (insulin monomer human rDNA origin) Inhalation Powder and the AFRESA Inhaler for the treatment of adults with type 1 or type 2 diabetes. The FDA issued a standard, 10-month review for the NDA, with a decision expected in mid-January 2010. Afresa is an ultra rapid-acting form of insulin (achieving peak levels within 12-14 minutes to mimic the normal physiological release of insulin in healthy individuals) that is delivered through an inhaler rather than the typical route of injection by a syringe. In early October, MNKD announced that it would not be able to sign a partnership deal for Afresa by year-end as it awaits the pending FDA decision, stating that the Company and potential partners will be better able to address appropriate deal terms and structure once the label for Afresa is clarified. In November 2007, Pfizer (NYSE: PFE) agreed to a settlement with Nektar Therapeutics (NASDAQ: NKTR) that included a one-time payment of $135 million to the latter after Exubera (the first FDA-approved inhaled insulin product) failed to generate meaningful sales despite a significant investment by Pfizer. In early May, Amylin Pharma (NASDAQ: AMLN), Eli Lilly (NYSE: LLY), and Alkermes (NASDAQ: ALKS) announced that a NDA was filed seeking FDA approval of exenatide (Byetta LAR) as a once-weekly formulation for type 2 diabetes which is administered by subcutaneous injection, with a FDA decision expected in early 2010. Byetta is currently approved for use as a twice-daily injection for patients with Type 2 diabetes and is classified as an incretin that exhibits many of the same actions as GLP-1 (glucagon-like peptide-1) which act by stimulating insulin release when glucose levels become high. Diabetes care companies in the Asia /Pacific region include Terumo Corp. (TYO: 4543) (OTC: TRUMY.PK) and Takeda Pharma (TYO: 4502) (OTC: TKPHY.PK). Terumo manufacturers medical devices / equipment such as insulin syringes while Takeda markets diabetes drug Actos with continued development of alogliptin as an experimental drug for Type 2 diabetes as both a single agent and in combination with Actos. In late June, Takeda received a Complete Response Letter (CRL) from the FDA for alogliptin, which is a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise that will require a cardiovascular safety study prior to possible FDA approval. In September, Vivus Inc. (NASDAQ: VVUS) announced positive results from two final, Phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa (phentermine + topiramate) in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and Type 2 diabetes. Vivus expects to file a NDA before year-end and has an <font> ongoing Phase 2 study </font> evaluating Qnexa in Type 2 diabetics. Access Pharma (OTC: ACCP.OB) has developed a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This drug delivery technology involves coating a nano-particle with a B12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package, resulting in 1,000 to 1,000,000-fold increases in absorption through the gut of large molecule drugs typically administered by injection. Licensing discussions are expected to formalize for the Company’s basal (long-acting) oral insulin product following the mid-June announcement that two bio-pharmaceutical companies will conduct preclinical, animal studies before proceeding to more formal negotiations. The results of these preclinical studies will be made public, including one North American biotech company and one European biotech company. Access is providing the oral insulin while the two interested companies will conduct one animal study each (including a rat and dog model) with data expected before year-end. Other investment opportunities related to diabetes care include (1) Unilife Medical Solutions (OTC: UNIFF.PK) (ASX: UNI.AX) (Unitract safety syringes, contract medical device manufacturing); (2) West Pharmaceutical Services (NYSE: WST) (syringe component manufacturer); (3) Retractable Technologies (AMEX: RVP) (VanishPoint safety syringes); (4) CPEX Pharma (NASDAQ: CPEX) (Nasulin is an experimental intranasal insulin product candidate); (5) Emisphere (OTC: EMIS.OB) (plans to change development focus to an oral formulation of a GLP-1 analog rather than continuing to pursue development of oral insulin). The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market includes diversified, global healthcare giants and smaller niche players, including those outlined below. Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Becton Dickinson (NYSE: BDX) (BD Diagnostics), Roche (OTC: RHHBY.PK) (Accu-Chek), Bayer (OTC: BAYRY.PK) (Ascenscia), Bio-Rad Labs (NYSE: BIO), Home Diagnostics (NASDAQ: HDIX), Insulet Corp. (NASDAQ: PODD), Echo Therapeutics (OTC: ECTE.OB), Trinity Biotech (NASDAQ: TRIB), and DexCom (NASDAQ: DXCM). <font> As I wrote last week </font> , Echo Therapeutics announced positive results in a pilot clinical study for its needle-free Symphony Transdermal Continuous Glucose Monitoring (tCGM) System as a non-invasive, wireless, transdermal solution for monitoring blood sugar levels when used in conjunction with the needle-free Prelude SkinPrep System. The Prelude SkinPrep has been licensed to Ferndale Pharma in North America + UK for the enhanced delivery of its topical lidocaine skin-numbing agent (LMX4), with a FDA 510(k) submission expected during 1Q10 for potential marketing clearance while the Symphony tCGM will be evaluated in a pivotal trial that is expected to begin by late February 2010 with a FDA PMA submission expected to follow. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my <font> 23 ProActive HavRx stock indexes </font> . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes. The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Disclosure: Long ACCP.OB, Epinex Diagnostics (privately held)
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January 26
Claymore's Airline ETF (FAA) Takes Flight
This pick is about: FAA (FAA)
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$0.0 (01/26/09)
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| Closed: |
04/14/2010
@ $37.39
(n/a
in
443 days)
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Claymore announced today that it has launched the first exchange-traded product for the global passenger airline industry in the form of an ETF with ticker 'FAA' , which is summarized below by the President of Claymore Securities, Christian Magoon, below: “Passenger airlines make up the vital networks by which the world connects itself, and we are happy to be the first ETF provider to offer investors access to a portfolio of some of the most actively traded global passenger airline stocks,” . . . “FAA is an industry first and yet another example of the innovation and insight Claymore strives to deliver to the marketplace.” The ETF will seek to replicate the NYSE Arca Global Airline Index (AXGAL), which is an index that tracks the performance of selected securities of passenger airlines from around the world. At each rebalance, the index will contain about 70% U.S. passenger airline companies, with the remaining weight allocated to international passenger airlines. The companies included in the Index must derive at least 50% of their revenue from passenger airline operations. Additionally, constituents must have a market capitalization of at least $100M and a 100-day average daily trading volume of at least $1M. As of December 31, 2008, the top five index constituents were AMR Corp (AMR), Continental Airlines Inc (CAL), Southwest Airlines Co (LUV), JetBlue Airways Corp (JBLU) and Delta Airlines Inc (DAL). While passenger airlines face obvious headwinds associated with the global economic slowdown, positive trends include sharply lower jet fuel costs and reduced capacity through M&A + grounded planes. Since the airline stocks offer tremendous volatility, FAA should be extremely popular with traders by providing a cost-efficient vehicle to trade the entire industry rather than taking on the added risk of investing in the individual companies.
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March 28
Near-Term Extreme FDA, Clinical Trial Trades: $DCTH, $CTIC, $ANX
This pick is about: Delcath Systems Inc (DCTH)
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$7.26 (03/28/10)
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| Closed: |
04/13/2010
@ $9.45
(+30.17%
in
16 days)
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The Regulatory Catalyst Index Update report is currently tracking 313 total entries that include select pending binary event data (FDA decisions, clinical trials) with 206 companies tracked, 155 companies under $10 per share, and 117 companies under $5 per share. Below is a sample of some companies with stock prices under $10, market caps below $500 million, and expected FDA and/or clinical trial catalysts within the next two months. <font> <font> 1.) Delcath Systems (NASDAQ:DCTH) ($7.26) (market cap = $264 million) </font> </font> <font> Delcath Percutaneous Hepatic Perfusion (PHP) System </font> <font> Pivotal Phase 3 Clinical Trial, FDA New Filing (Rolling NDA Submission) </font> <font> DCTH expects to report pivotal study results in April for the regional delivery of high-dose melphalan via the Delcath PHP System to the liver for metastatic melanoma patients with un-removable tumors. Based on these results, DCTH expects a pending FDA new filing based on Fast Track status and a rolling submission to expedite the NDA process and expects to file for a CE Mark (Europe) as a Class III Medical Device by year-end. </font> <font> <font> 2.) Cell Therapeutics (NASDAQ:CTIC) ($0.64) ($394 million) </font> </font> <font> Pending FDA Decision for Pixuvri (pixantrone) Injection </font> <font> The PDUFA action goal date is 4/23/10, seeking approval to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). The NerPharMa manufacturing facility was approved by FDA 3/8/10, but the ODAC FDA Advisory Panel voted unanimously on 3/22/10 that trial data was not adequate to support approval of pixantrone. The risk / reward trade on CTIC has changed drastically </font> <font> since I wrote about the Company as a high-risk, speculative trade </font> <font> on a comeback from the brink while trading at 8 cents in February 2009. </font> <font> Shares of CTIC have been on a wild ride since that time, trading as high as the $2 per share mark for an astounding 25X return in the interim and highlights the importance of taking profits when you have them in the hyper-volatile, small/micro-cap bio-medical space - especially if this opportunity presents itself ahead of the expected binary event. Also, the experience with CTIC highlights the fact that momentum trading in stocks with major pending FDA decisions and/or clinical trial results takes on a life of its own as the big date approaches that is often separated from the underlying science, potential market opportunity, and other rationale attempts to place a fair value on such stocks. </font> <font> <font> 3.) ADVENTRX Pharma (AMEX:ANX) ($0.226) ($35 million) </font> </font> <font> ANX-530 (vinorelbine injectable emulsion) </font> <font> ANX received a Refusal to file (RTF) letter on 3/1/10 from FDA, which cited one chemistry, manufacturing and controls (CMC) issue related to product stability / expiration dating period. ANX plans to meet with FDA to discuss the NDA resubmission during the last week of April. </font> <font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed HavRx Regulatory Catalyst Index. </font> <font> Disclosure: Long DCTH </font>
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January 21
Calendar of 163 FDA Decisions and Clinical Trials
This pick is about: ChemGenex Pharmaceuticals Ltd Sponsored ADR (CXSP)
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$11.25 (01/21/09)
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| Closed: |
04/13/2010
@ $0.0
( n/a)
in
447 days)
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The tables at my web link below include an updated calendar of 80 expected FDA new product decisions and 83 pending clinical trial result estimates + pending FDA re-submissions. Click here for a link to my previous FDA calendars and the below is a summary of new entries and updates on the calendars. 1.) Genentech (DNA) expects to report results in mid-April in its Avastin colon cancer adjuvant trial, in addition to pending FDA decisions to expand product labels for Avastin in relapsed brain cancer (gliobalstoma) by 5/5/09, Avastin in combination with interferon alfa-2a for the treatment of metastatic renal cell (kidney) carcinoma by 8/1/09, and Xolair (omalizumab) to extend its use in asthma therapy to kids age 6 and older by the end of October. 2.) Takeda Pharma (TKPHY) announced that the FDA would miss the 1/18/09 PDUFA date for its Febuxostat NDA in the treatment of hyperuricemia (once-daily oral treatment of high uric acid levels in gout patients). The FDA is simply behind schedule on pending inspection of clinical trial sites and Febuxostat previously was recommended for approval by an advisory panel. 3.) Dendreon (DNDN) moved up the timeline from mid-year to April for the release of Provenge clinical trial results for prostate cancer as part of its rolling BLA submission. 4.) Genzyme (GENZ) should hear back from the FDA on its sNDA to expand the label for Clolar (clofarabine) in the treatment of adult acute myeloid leukemia - AML). The 1/24/09 date is for the agency to accept the filing and decide if a six-month, priority review will be granted. 5.) ChemGenex Pharma (CXSP) received Orphan Drug status for Omacetaxine in the treatment of Myelodysplastic Syndromes and expected to complete its rolling NDA submission by mid-year.
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March 27
Single Digit FDA, Clinical Trial Stocks: $GNVC, $ACUR, $CADX, $CYTX
This pick is about: Cytori Therapeutics Inc (CYTX)
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$4.59 (03/27/10)
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| Closed: |
04/11/2010
@ $4.66
(+1.53%
in
15 days)
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The HavRx Regulatory Catalyst Index Update report is currently tracking 313 total entries that include select pending binary event data (FDA decisions, clinical trials) with 206 companies tracked, 155 companies under $10 per share, and 117 companies under $5 per share. <font> <font> 1.) GenVec (NASDAQ:GNVC) ($2.90) (market cap = $362 million) </font> </font> <font> TNFerade (DNA carrier, adenovector with gene for TNF-alpha) </font> <font> Phase 3 Pancreatic Cancer Clinical Trial (PACT) </font> <font> GNVC announced on 1/15/10 the 184th death in PACT study and guided for 10-12 weeks at the time for interim data to be reported while the final data analysis will occur after 276 deaths are reached. More recently, GNVC reported earnings and provided guidance for expected interim results in March or April 2010. </font> <font> <font> 2.) Acura Pharma (NASDAQ:ACUR) ($5.16) (market cap = $226 million) </font> </font> <font> Acurox (oxycodone and niacin) Tablets </font> <font> FDA Advisory Panel Meeting, 505(b)(2) NDA Resubmission </font> <font> Acurox is partnered with King Pharma (NYSE:KG) and both companies reported results to support the abuse-deterrant potential of this pain drug candidate on 3/8/10. A Complete Response Letter (CRL) was received from FDA in June 2009 and a joint meeting of the Anesthetic / Life Support Drugs and Drug Safety / Risk Management Advisory Committees of the FDA is scheduled for 4/22/10. </font> <font> <font> 3.) Cadence Pharma (NASDAQ:CADX) ($9.26) (market cap = $468 million) </font> </font> <font> Ofirmev (intravenous or IV formulation of acetaminophen) </font> <font> The FDA issued a CRL on 2/11/10 that noted third-party manufacturer deficiencies (with a submitted response to FDA on 2/18/10) and indicated that no additional clinical studies are required required. CADX is seeking approval of Ofirmev for the treatment of pain and the reduction of fever in adults and children and expects to resubmit the NDA once all inspection-related issues are resolved. </font> <font> <font> 4.) Cytori Therapeutics (NASDAQ:CYTX) ($4.59) (market cap = $196 million) - Celution System </font> </font> <font> CYTX is scheduled to report full six-month results from the APOLLO trial (heart attack) and preliminary six-month results from the PRECISE trial (chronic ischemia on 5/7/10 at the Stem Cell Therapy and Cardiovascular Innovation conference in Madrid, Spain. These safety and feasibility studies will evaluate the potential of autologous (patient-derived) adipose (fat tissue) derived stem and regenerative cells in the acute and chronic cardiac disease settings based on output from the Company's Celution System. </font> <font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed HavRx Regulatory Catalyst Index. </font> <font> Disclosure: Long CYTX </font>
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June 26
Investars YOU: New Site for Index Tracking and Investing
This pick is about: Biotech HOLDRs Trust Biotech HOLDRs Trust (BBH)
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$94.21 (06/26/09)
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| Closed: |
04/09/2010
@ $104.26
(+10.67%
in
287 days)
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Below are 20 new stock indexes I have created, revised, and tracked over the past few years which are now featured at a new website called Investars YOU. The new site includes automated index tracking and allows investors to create custom stock portfolios based on their individual preferences. <o:p> </o:p> http://biomedreports.com/articles/most-popular/1630-investars... <o:p> </o:p> Cosmetic & Restorative Medicine Index http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Cosmetic and Restorative Medicine Index passively tracks the performance of companies that derive over 50% of revenue from any of the following activities: (1) prescription skin care therapeutics; (2) medical devices, products, services, OR equipment for procedures which are intended to enhance appearance; (3) medical devices, products, services, OR equipment for use as joint replacements, tissue repair agents, tissue reconstruction agents, surgical adhesives, and cardiovascular procedures; and (4) regenerative medicine products, services, and/or an active clinical pipeline which seeks to restore or repair the functionality of lost or damaged organ, tissue, cellular, and genetic material. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> BioMedReports.com Select Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The BioMedReports.com Select Index is an actively managed model portfolio of 30-40 stocks that will maintain at least a 90% sector weighting in healthcare with a focus on emerging small and micro-cap bio-pharmaceutical companies with market caps below $1 billion. Mid and large-cap stocks with market caps over $1 billion will typically account for about one-third to one-half of the index components. The selections will be made based on my research, experience, and activities as Managing editor of the website to identify companies which appear as either undervalued or those which are likely to benefit from upcoming binary event catalysts in the form of FDA decisions or key clinical trial results. <o:p> </o:p> Cancer Dx/Tx Micro-Cap Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The passively managed Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index constituents reflect a cross-section of emerging cancer companies with market caps below $250 million at the inception date of 4/12/09, including (1) diagnostics (molecular diagnostics and device-based diagnostics), (2) lab services (personalized medicine applications to guide and track the effectiveness of cancer treatments), (3) drug discovery (screening and modifying compounds to achieve anti-cancer effects during the early stages of preclinical and Phase 1 clinical studies), (4) immunotherapy (a.k.a. cancer vaccines which are designed to stimulate the immune system to eradicate cancer), and (5) commercial or late-stage (Phase 2-3) clinical development. Components will only be removed from the index due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company`s stock. <o:p> </o:p> Emerging Diagnostics Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Emerging Diagnostics Index is passively managed and tracks the performance of companies with market caps below $250 million at the time of inclusion. The index includes diabetes monitoring device makers, laboratory services, clinical diagnostics, diagnostic imaging, diagnostic equipment makers, and molecular diagnostics. The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company’s stock. <o:p> </o:p> Global Airline Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Airline Index passively tracks the performance of companies with market caps over $200 million at the inception date of 7/16/08 which derive over 50% of revenue from passenger airline services. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Carbon Trading Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The passively managed Global Carbon Trading Index tracks the performance of companies which generate carbon credits through their business operations and/or are involved with the trading of carbon credits. Examples of these activities include the following: waste-to-energy, landfill or methane gas collection, financial exchanges for carbon credits, carbon credit investment firms, and renewable energy projects that result in the generation of carbon credits (e.g. hydro-power, farming, industrial). The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company`s stock. <o:p> </o:p> Global Generic Drug Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Generic Drug Index passively tracks the performance of companies which meet any of the following three requirements: (1) Derive either $500 million (USD) OR more than 50% of trailing 12-month revenues from the manufacture and sale of any type of generic (off-patent) prescription or over-the-counter (OTC) drug product intended for use by humans, including contract manufacturing services for drug products and biological agents; (2) Have one or more compound(s) in active clinical development OR have a pending ANDA with the FDA for a generic drug candidate; (3) As an alternative to the revenue requirement, companies may also qualify by receiving FDA approval for an abbreviated new drug application (ANDA) within the past 12 months. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Health IT Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Health Information Technology (Health IT) Index passively tracks the performance of companies with market caps below $10 billion that derive over either $50 million or 50% of their trailing 12-month revenue from products and services for the following activities: (1) electronic transmission, storage, and processing of prescriptions; (2) secure e-mail transmission for healthcare facilities; (3) electronic transmission, storage, and processing of medical imaging and diagnostic information; (4) electronic storage and systems for administrative functions of healthcare facilities and medical records; (5) electronic transmission, storage, and systems for healthcare market data and clinical trial data; (6) electronic systems, devices, and services for remote, real-time monitoring of patient health parameters; (7) medical transcription services, products, and systems for conversion into electronic medical records. <o:p> </o:p> Global Metal Mining Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Metal Mining Index passively tracks the top-rated companies with market caps over $1 billion at the inception date of 7/22/08 that derive over 50% of revenue from the exploration, mining, extraction, processing, and sale of all types of precious metals, minerals, and industrial metals. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and net income weighting. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Railroad Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Railroad Index passively tracks the performance of companies that derive either more than 50% OR $100 million of trailing 12-month revenue from any of the following activities: (1) passenger or freight rail transport services; (2) railcar and locomotive leasing; (3) railcar and locomotive fleet management; (4) rail infrastructure, railcar, locomotive, and railcar/locomotive component parts manufacturing; (5) railcar, locomotive, and component parts repair or refurbishment. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Stem Cell Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Stem Cell Index is passively managed to track the performance of regenerative medicine companies (with stock prices of at least 15 cents at the time of inclusion) which derive over 50% of revenue or have compound(s) in active pre-clinical or clinical development which are designed to restore, replace, repair, or enhance the functionality or appearance of tissue and organ systems, including all types of embryonic and adult stem cell therapeutics. In addition, all types of products and services for stem cell banking are included in this index. The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company’s stock. <o:p> </o:p> Global Telecom Services Dividend Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Telecom Services Dividend Index passively tracks the performance of companies with market caps over $1 billion at the time of inclusion that meet the following requirements: (1) All such companies must derive at least 50% of their trailing 12-month revenue from any types of voice and data telecom services such as fixed line communications, wireless communications, and internet access provider services and (2) All such companies must have a trailing 12-month dividend yield of at least 1.5%. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Tobacco Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Tobacco Index tracks the performance of companies which derive over 50% of their revenue from the distribution or manufacturing of any type of tobacco product (e.g. cigarettes, cigars, chewing tobacco) or any related tobacco supplies (e.g. wrapping papers, tobacco leafs, filters). The index is passively managed with updates only as needed to reflect mergers, bankruptcies, and other corporate events which affect the component stocks. <o:p> </o:p> Global Trucking & Logistics Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Trucking & Logistics Index passively tracks the performance of companies with market caps over $100 million at the time of inclusion that derive at least 50% of trailing 12-month revenue from any of the following activities: logistics and management support services for all types of transportation companies; all types of land-based, roadway freight forwarding freight transportation services; mail package delivery, transportation, and logistics services; and logistics management support services for roadway transportation companies. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Health Benefit Providers Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Health Benefit Providers Index is passively managed to track the performance of retail pharmacies, pharmacy benefit managers, managed care companies, health insurers, hospital pharmacy operators, workers compensation insurers, and specialty health benefit providers. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in the de-listing of the Company`s stock. <o:p> </o:p> Highly Defensive Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Highly Defensive Index passively tracks the performance of 35 companies based in the Americas, Canada, and Europe with the largest market caps from the following industry groups: (A) Mass Merchant Discount Retailer (1); (B) Consumer Staples (11); (C) Telecom Services (3); (D) At-Home Services (2): Cable TV/Internet Provider (1), Internet Portal/Search Provider (1); (E) Electric Utilities – Domestic (U.S. based) (2); (F) Fast Food Restaurants (1); (G) Commodities (2): Gold Mining (1) Agri-Biotech (Seeds & Fertilizers) (1); (H) Healthcare (11); (I) Aerospace (Non-Commercial) & Defense (1); (J) Energy (1). Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Nation Cap Leaders Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Nation Cap Leaders Index passively tracks the performance of companies with market caps over $5 billion at the inception date of 8/11/08 which represent the market cap leaders from each nation, spanning developed, emerging, and frontier markets. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> NordiCaps Region Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The NordiCaps Region Index passively tracks the top-rated companies with market caps over $1 billion at the inception date of 7/21/08 that are based in the Nordic Region countries of Sweden, Denmark, Finland, Iceland, and Norway. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and revenue weighting. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Preventive Medicine Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Preventive Medicine Index passively tracks the performance of companies with market caps over $100 million at the time of inclusion that derive over either 50% or $100 million in trailing 12-month revenue from any of the following activities: (1) human vaccines which are already on the market or in active clinical development; (2) diagnostics and lab services; (3) diabetes care; and (4) vitamins, health supplements, functional foods, and weight loss products or services. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Regulatory Catalyst Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Regulatory Catalyst Index tracks the performance of healthcare companies with pending new drug, biological agent, or medical device product decisions at the FDA. The index is actively managed and derived from the BioMedReports.com FDA Calendar database.
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Investars YOU: New Site for Index Tracking and Investing
This pick is about: SPDR S&P Biotech ETF (XBI)
| Rating: |
$50.54 (06/26/09)
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| Closed: |
04/09/2010
@ $60.99
(+20.68%
in
287 days)
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Below are 20 new stock indexes I have created, revised, and tracked over the past few years which are now featured at a new website called Investars YOU. The new site includes automated index tracking and allows investors to create custom stock portfolios based on their individual preferences. <o:p> </o:p> http://biomedreports.com/articles/most-popular/1630-investars... <o:p> </o:p> Cosmetic & Restorative Medicine Index http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Cosmetic and Restorative Medicine Index passively tracks the performance of companies that derive over 50% of revenue from any of the following activities: (1) prescription skin care therapeutics; (2) medical devices, products, services, OR equipment for procedures which are intended to enhance appearance; (3) medical devices, products, services, OR equipment for use as joint replacements, tissue repair agents, tissue reconstruction agents, surgical adhesives, and cardiovascular procedures; and (4) regenerative medicine products, services, and/or an active clinical pipeline which seeks to restore or repair the functionality of lost or damaged organ, tissue, cellular, and genetic material. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> BioMedReports.com Select Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The BioMedReports.com Select Index is an actively managed model portfolio of 30-40 stocks that will maintain at least a 90% sector weighting in healthcare with a focus on emerging small and micro-cap bio-pharmaceutical companies with market caps below $1 billion. Mid and large-cap stocks with market caps over $1 billion will typically account for about one-third to one-half of the index components. The selections will be made based on my research, experience, and activities as Managing editor of the website to identify companies which appear as either undervalued or those which are likely to benefit from upcoming binary event catalysts in the form of FDA decisions or key clinical trial results. <o:p> </o:p> Cancer Dx/Tx Micro-Cap Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The passively managed Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index constituents reflect a cross-section of emerging cancer companies with market caps below $250 million at the inception date of 4/12/09, including (1) diagnostics (molecular diagnostics and device-based diagnostics), (2) lab services (personalized medicine applications to guide and track the effectiveness of cancer treatments), (3) drug discovery (screening and modifying compounds to achieve anti-cancer effects during the early stages of preclinical and Phase 1 clinical studies), (4) immunotherapy (a.k.a. cancer vaccines which are designed to stimulate the immune system to eradicate cancer), and (5) commercial or late-stage (Phase 2-3) clinical development. Components will only be removed from the index due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company`s stock. <o:p> </o:p> Emerging Diagnostics Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Emerging Diagnostics Index is passively managed and tracks the performance of companies with market caps below $250 million at the time of inclusion. The index includes diabetes monitoring device makers, laboratory services, clinical diagnostics, diagnostic imaging, diagnostic equipment makers, and molecular diagnostics. The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company’s stock. <o:p> </o:p> Global Airline Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Airline Index passively tracks the performance of companies with market caps over $200 million at the inception date of 7/16/08 which derive over 50% of revenue from passenger airline services. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Carbon Trading Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The passively managed Global Carbon Trading Index tracks the performance of companies which generate carbon credits through their business operations and/or are involved with the trading of carbon credits. Examples of these activities include the following: waste-to-energy, landfill or methane gas collection, financial exchanges for carbon credits, carbon credit investment firms, and renewable energy projects that result in the generation of carbon credits (e.g. hydro-power, farming, industrial). The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company`s stock. <o:p> </o:p> Global Generic Drug Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Generic Drug Index passively tracks the performance of companies which meet any of the following three requirements: (1) Derive either $500 million (USD) OR more than 50% of trailing 12-month revenues from the manufacture and sale of any type of generic (off-patent) prescription or over-the-counter (OTC) drug product intended for use by humans, including contract manufacturing services for drug products and biological agents; (2) Have one or more compound(s) in active clinical development OR have a pending ANDA with the FDA for a generic drug candidate; (3) As an alternative to the revenue requirement, companies may also qualify by receiving FDA approval for an abbreviated new drug application (ANDA) within the past 12 months. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Health IT Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Health Information Technology (Health IT) Index passively tracks the performance of companies with market caps below $10 billion that derive over either $50 million or 50% of their trailing 12-month revenue from products and services for the following activities: (1) electronic transmission, storage, and processing of prescriptions; (2) secure e-mail transmission for healthcare facilities; (3) electronic transmission, storage, and processing of medical imaging and diagnostic information; (4) electronic storage and systems for administrative functions of healthcare facilities and medical records; (5) electronic transmission, storage, and systems for healthcare market data and clinical trial data; (6) electronic systems, devices, and services for remote, real-time monitoring of patient health parameters; (7) medical transcription services, products, and systems for conversion into electronic medical records. <o:p> </o:p> Global Metal Mining Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Metal Mining Index passively tracks the top-rated companies with market caps over $1 billion at the inception date of 7/22/08 that derive over 50% of revenue from the exploration, mining, extraction, processing, and sale of all types of precious metals, minerals, and industrial metals. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and net income weighting. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Railroad Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Railroad Index passively tracks the performance of companies that derive either more than 50% OR $100 million of trailing 12-month revenue from any of the following activities: (1) passenger or freight rail transport services; (2) railcar and locomotive leasing; (3) railcar and locomotive fleet management; (4) rail infrastructure, railcar, locomotive, and railcar/locomotive component parts manufacturing; (5) railcar, locomotive, and component parts repair or refurbishment. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Stem Cell Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Stem Cell Index is passively managed to track the performance of regenerative medicine companies (with stock prices of at least 15 cents at the time of inclusion) which derive over 50% of revenue or have compound(s) in active pre-clinical or clinical development which are designed to restore, replace, repair, or enhance the functionality or appearance of tissue and organ systems, including all types of embryonic and adult stem cell therapeutics. In addition, all types of products and services for stem cell banking are included in this index. The index will only be updated to remove components which are no longer trading due to mergers, bankruptcies, or other corporate events that result in de-listing of the Company’s stock. <o:p> </o:p> Global Telecom Services Dividend Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Telecom Services Dividend Index passively tracks the performance of companies with market caps over $1 billion at the time of inclusion that meet the following requirements: (1) All such companies must derive at least 50% of their trailing 12-month revenue from any types of voice and data telecom services such as fixed line communications, wireless communications, and internet access provider services and (2) All such companies must have a trailing 12-month dividend yield of at least 1.5%. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Global Tobacco Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Tobacco Index tracks the performance of companies which derive over 50% of their revenue from the distribution or manufacturing of any type of tobacco product (e.g. cigarettes, cigars, chewing tobacco) or any related tobacco supplies (e.g. wrapping papers, tobacco leafs, filters). The index is passively managed with updates only as needed to reflect mergers, bankruptcies, and other corporate events which affect the component stocks. <o:p> </o:p> Global Trucking & Logistics Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Global Trucking & Logistics Index passively tracks the performance of companies with market caps over $100 million at the time of inclusion that derive at least 50% of trailing 12-month revenue from any of the following activities: logistics and management support services for all types of transportation companies; all types of land-based, roadway freight forwarding freight transportation services; mail package delivery, transportation, and logistics services; and logistics management support services for roadway transportation companies. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Health Benefit Providers Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Health Benefit Providers Index is passively managed to track the performance of retail pharmacies, pharmacy benefit managers, managed care companies, health insurers, hospital pharmacy operators, workers compensation insurers, and specialty health benefit providers. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in the de-listing of the Company`s stock. <o:p> </o:p> Highly Defensive Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Highly Defensive Index passively tracks the performance of 35 companies based in the Americas, Canada, and Europe with the largest market caps from the following industry groups: (A) Mass Merchant Discount Retailer (1); (B) Consumer Staples (11); (C) Telecom Services (3); (D) At-Home Services (2): Cable TV/Internet Provider (1), Internet Portal/Search Provider (1); (E) Electric Utilities – Domestic (U.S. based) (2); (F) Fast Food Restaurants (1); (G) Commodities (2): Gold Mining (1) Agri-Biotech (Seeds & Fertilizers) (1); (H) Healthcare (11); (I) Aerospace (Non-Commercial) & Defense (1); (J) Energy (1). Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Nation Cap Leaders Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Nation Cap Leaders Index passively tracks the performance of companies with market caps over $5 billion at the inception date of 8/11/08 which represent the market cap leaders from each nation, spanning developed, emerging, and frontier markets. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> NordiCaps Region Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The NordiCaps Region Index passively tracks the top-rated companies with market caps over $1 billion at the inception date of 7/21/08 that are based in the Nordic Region countries of Sweden, Denmark, Finland, Iceland, and Norway. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and revenue weighting. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Preventive Medicine Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Preventive Medicine Index passively tracks the performance of companies with market caps over $100 million at the time of inclusion that derive over either 50% or $100 million in trailing 12-month revenue from any of the following activities: (1) human vaccines which are already on the market or in active clinical development; (2) diagnostics and lab services; (3) diabetes care; and (4) vitamins, health supplements, functional foods, and weight loss products or services. Index components will be removed to reflect corporate events such as mergers and bankruptcies which result in de-listing of the underlying stocks. <o:p> </o:p> Regulatory Catalyst Index: http://www.investinwhoyouare.com/iip_you_profiles.aspx?Portfo... <o:p> </o:p> The Regulatory Catalyst Index tracks the performance of healthcare companies with pending new drug, biological agent, or medical device product decisions at the FDA. The index is actively managed and derived from the BioMedReports.com FDA Calendar database.
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March 19
HavRx Regulatory Catalyst Index up 80% since June 2009
This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
| Rating: |
$91.48 (03/19/10)
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| Closed: |
04/09/2010
@ $91.9
(+0.46%
in
21 days)
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The actively managed <font> HavRx Regulatory Catalyst Index </font> <font> tracks the performance of select companies which meet any of the following requirements: (1) pending new drug, biological agent, medical device, or diagnostic product applications at the FDA; (2) pending pivotal clinical trial results that are designed to support a new filing or resubmission for FDA marketing clearance; and (3) pending early stage clinical study results. Categories (1) and (2) will comprise two-third (67%) or greater of all index components while companies with pending early stage clinical trial results will comprise one-third (33%) or less of all index components. </font> <font> </font>  <font> </font> <font> <font> mikehavRx.com Index Updates </font> <font> is a premium service that provides investors with time-saving information and updates on unique global baskets of stocks that are organized and managed within the 18 HavRx Stock Indexes outlined below <font> that are being tracked at the Investars YOU website since June 2009. <font> Regulatory Catalyst Index Updates include daily updates on regular market trading days for active index components, watch list stocks, and binary event (FDA, clinical trials) summary information. </font> </font> </font> </font> <font> </font> <font> Regulatory Catalyst Index Update Statistics (as of 3/19/10 market close) </font> - <font> 284 total entries to track select pending binary event data (FDA decisions, clinical trials) </font>
- <font> 186 companies tracked, including 95 active index components </font>
- <font> 143 companies under $10 per share, 107 companies under $5 per share </font>
<font> </font> <font> mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed Regulatory Catalyst Index. Please visit </font> <font> www.mikehavRx.com </font> <font> for more details on my new publishing company, website, and premium service. </font>
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April 06
FDA, Clinical Trial News: $FRX $IMGG $RPRX
This pick is about: Forest Laboratories Inc (FRX)
| Rating: |
$30.96 (04/06/10)
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| Closed: |
04/08/2010
@ $32.46
(+4.84%
in
2 days)
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Forest Labs (NYSE:FRX) Daxas (roflumilast) (a once-daily oral treatment) An FDA Advisory Panel meeting is scheduled for Wednesday and FRX is seeking approval for symptomatic COPD (chronic obstructive pulmonary disease) to reduce exacerbations. Briefing documents filed ahead of the advisory panel meeting noted proposed label changes were submitted by FRX in late January (less than two months ahead of panel review) and the incidence of psychiatric side effects. Imaging3 (OTCBB:IMGG) Dominion Volumetric Imaging Scanner (DViS) Technolgy for three-dimensional (3D) medical imaging IMGG announced late on 4/5/10 that it submitted the Company’s latest response to FDA, which was previously described as additional imaging data that was pending review and processing by radiologists in support of its FDA 510(k) submission. Repros Therapeutics (NASDAQ:RPRX) Proellex (telapristone acetate) On 4/5/10, RPRX requested a lift of the full FDA clinical hold (Aug. 2009 due to liver toxicity), for the experimental treatment of uterine fibroids and endometriosis, and the Company proposed a single study to determine the potential for developing a low-dose (12 mg or lower) oral anti-progestin therapy. <font> www.mikehavRx.com </font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials (currently tracking over 230 companies and 360 entries), which are tracked in the actively managed HavRx Regulatory Catalyst Index. NEW! 50% discount promo codes are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. Disclosure: No positions
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December 09
Trading the Trials: Cytori and Cypress Bio
This pick is about: Forest Laboratories Inc (FRX)
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$23.45 (12/09/08)
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04/06/2010
@ $30.96
(+32.03%
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482 days)
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 Cytori Therapeutics (CYTX) reported preclinical study results in large animals which demonstrated the ability of adipose-derived stem and regenerative cells [ADRCs] to repair and increase the tissue density of damaged spinal discs, which was retained at both six and 12-month follow-up assessments. The study demonstrates the potential for a patient's own ADRCs to heal injured spinal discs in a safe manner (as no inflammation was present within the disc space), with results expected to be reported in full next spring. Cytori has rebounded nicely since briefly falling below two bucks and traded up today by nearly 13% to $2.90 per share. CYTX is also a component in the ETF Innovators [ETFI] Cosmetic & Reconstructive Medicine Index, which includes other commercial-stage stem cell and regenerative medicine companies such as Osiris Therapeutics (OSIR), RTI Biologics (RTIX), and Integra LifeSciences (IART). Regenerative medicine represents the next frontier for big pharma R&D with companies such as Pfizer (PFE) and Johnson & Johnson (JNJ) entering the space through partnerships and investments. Forest Labs (FRX) and Cypress Bioscience (CYPB) announced positive Phase 3 results for milnacipran in the treatment of fibromyalgia, which was statistically significant compared to placebo. More detailed results are expected next year as the data is analyzed is further. Both companies are still awaiting a missed FDA decision deadline from mid-October, with today's data confirming the efficacy of milnacipran with a separate cardiovascular study undertaken to address any possible concerns by the agency with regard to increased blood pressure or heart rate. Despite the good news today, CYPB is still trading below 6 bucks despite having no debt and about 4 bucks per share in cash – making the stock a buy ahead of a likely FDA approval for milnacipran.
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April 03
Immune-Based Treatments for Brain Cancer Post Impressive Early-Stage Results
This pick is about: Celldex Therapeutics Inc (CLDX)
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$6.17 (04/03/10)
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04/06/2010
@ $6.03
(-2.27%
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3 days)
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According to NCI/NIH statistics <font> , approximately 19,000 individuals in the US are diagnosed with primary brain cancers each year (with a similar number estimated to occur in Europe) with Temodar (temozolomide or TMZ) given to nearly every patient with a diagnosis of GBM, which is the most common and aggressive form of primary brain cancer. Newly diagnosed individuals with GBM typically undergo surgery to remove the tumor, followed by radiation (RT) and chemotherapy (TMZ). </font> <font> In May 2009, Roche (OTC:RHHBY) announced that the FDA granted accelerated approval (based on Phase 2 data, including OS of 9.2 months for recurrent GBM) of Avastin (bevacizumab) for the treatment of patients with GBM that have progressive disease following prior therapy. In March 2010, </font> <font> Health Canada also approved Avastin </font> <font> for use as a single agent for the treatment of patients with GBM after relapse or disease progression following prior therapy. Avastin is not yet approved in Europe for GBM and Roche is currently conducting a Phase 3 AVAGLIO study for this indication. </font> <font> In addition, Eisai (OTC:ESALY) markets the Gliadel Wafer (polifeprosan 20 with carmustine implant), which is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation as well as in patients with recurrent GBM as an adjunct to surgery. </font> <font> Below is a summary analysis of published data for the treatment of GBM, with the following abbreviations used throughout: RT=radiation therapy, TMZ=Temodar (chemotherapy), n=number of patients evaluated, PFS=progression free survival (listed in months), OS=overall survival (listed in months), 1Y=one-year, 2Y=two-year. </font> <font> 1.) </font> <font> Stupp et al. New England Journal of Medicine (NEJM), March 2005 </font> <font> (historical control) </font> <font> a.) RT+TMZ </font> <font> n=287 PFS=6.9 OS=14.6 1Y-OS=61.1% 2Y-OS=26.5% </font> <font> 2.) </font> <font> Grossman et al. ASCO 2009 </font> <font> . Summary data presented below for three novel agents + RT + TMZ evaluated in single-arm Phase 2 studies with the same eligibility criteria. </font> <font> a.) Talampanel (no PFS data) </font> <font> n=60 OS=20.3 1Y-OS=78% 2Y-OS=42% </font> <font> b.) Poly ICLC (no PFS data) </font> <font> n=85 OS=18.3 1Y-OS=79% </font> <font> c.) Celingitide (no PFS data) (Merck KGaA, OTC:MKGAY) </font> <font> n-102 OS=21.9 1Y-OS=82% </font> <font> 3.) </font> <font> Sampson et al. ASCO 2009 Poster Presentation </font> <font> (CDX-110, Celldex/Pfizer) </font> <font> a.) ACTIVATE study: RT+TMZ+CDX-110 </font> <font> n=18 PFS=14.2 OS=26 1Y-OS=94% 2Y-OS=53% </font> <font> b.) ACT II study: RT+TMZ+CDX-110 </font> <font> n=22 PFS=15.2 OS=23.6 1Y-OS=100% 2Y-OS=50% </font> <font> c.) Matched historical control: RT+TMZ </font> <font> n=17 PFS=6.3 OS=15 1Y-OS=70% 2Y-OS=6% </font> <font> 4.) </font> <font> Yu et al. 2009 </font> <font> . A phase I trial of tumor associated antigen-pulsed dendritic cell immunotherapy for patients with glioblastoma. </font> <font> Presented at the Congress of Neurological Surgeons Annual Meeting on October 26, 2009. (ICT-107, IMUC) </font> <font> a.) RT+TMZ+ICT-107 (median OS data not yet reached, estimated at 36 months) </font> <font> n=16 PFS=17.7 1Y-OS=100% 2Y-OS=75% </font> <font> ImmunoCellular Therapeutics (OTCBB:IMUC) - $1.10, market cap = $18 million </font> <font> ICT?107 autologous (patient-derived) dendritic cell (DC) therapeutic cancer vaccine candidate </font> <font> IMUC expects to apply for Orphan Drug status 2Q10 and expects to begin a Phase 2 study during 4Q10. As previously reported, a Phase I study showed median progression-free survival (PFS) of 19 months in GBM patients. ICT-107 targets six cancer-specific peptide antigens (a multi-epitope cancer vaccine targeting the following: HER2, TRP-2, gp100, MAGE-1, IL13R alpha, and AIM-3), including targets that are highly expressed on cancer stem cells. </font> <font> ICT-121 (off-the-shelf + adjuvant therapeutic cancer stem cell or CSC vaccine candidate) </font> <font> IMUC has identified novel peptides to broaden the potential use and has filed for a provisional US patent. IMUC expects an IND filing for GBM during 2H10 and may begin a Phase I study for this indication by year-end 2010 while also exploring the possibility of a licensing / development agreement as it focuses its resources on the Phase 2 development of ICT-107 as a priority for in-house development. </font> <font> Peregrine Pharma (NASDAQ:PPHM) - $3.15, market cap = $162 million </font> <font> Cotara (a targeted, anti-cancer monoclonal antibody, radio-isotope combo) </font> <font> PPHM has expanded its Phase 2 brain cancer program into the US and expects to complete patient enrollment in the 40-patient study during 2010. In addition, PPHM previously announced published long-term data from prior studies with 25% (7 of 28) GBM patients surviving over 1 year and 3 of 28 (10.7%) patients surviving after five years of treatment </font> <font> Exelixis (NASDAQ:EXEL) - $6.66, market cap = $719 million </font> <font> XL765 (anti-cancer agent that inhibits PI3K and mTOR or mammalian target of rapamycin) </font> <font> Phase 1b/2 study with Temodar for GBM </font> <font> XL184 (anti-cancer agent that inhibits MET, VEGFR2, and RET) </font> <font> Phase 2 study for GBM </font> <font> Curis Inc. (NASDAQ:CRIS) - $3.04, market cap = $230 million </font> <font> GDC-0449 (Hedgehog pathway inhibitor, anti-cancer agent) </font> <font> The National Cancer Institute (NCI) is currently sponsoring a Phase I study in young patients (age 3-21) with medulloblastoma that is recurrent or did not respond to previous treatment, a Phase 2 study in adult patients with recurrent or refractory medulloblastoma, and a Phase 2 study in patients with recurrent GBM that can be removed by surgery. </font> <font> Celldex Therapeutics (NASDAQ:CLDX) - $6.17, market cap = $196 million </font> <font> CDX-110 (EGFRvIII therapeutic cancer vaccine) (variant of epidermal growth factor receptor, EGFR) </font> <font> Co-developed with Pfizer (NYSE:PFE) with an ongoing Phase 2 study (ACT III) in patients with newly diagnosed GBM (brain cancer) that is fully enrolled (60 patients). </font> <font> YM BioSciences (AMEX:YMI) - $1.19, market cap = $78 million </font> <font> Nimotuzumab (nimo) (a humanized epidermal growth factor or EGFR-targeting monoclonal antibody, mAb) </font> <font> The following are brain cancer related studies for nimo that have expected data in 2010: Phase 3 adult glioma (2Q10), Phase 2 pediatric glioma (3Q10), and Phase 2 brain mets (spread) from lung cancer (4Q10) </font> <font> In addition, YMI has acquired CYT997 (a small molecule vascular disrupting agent or VDA) with results expected 2Q10 for a Phase I/II study in patients with GBM. </font> <font> Northwest Biotherapeutics (OTCBB:NWBO) - $0.83, market cap = $48 million </font> <font> NWBO is developing DCVax-Brain as a personalized, active immunotherapy for brain cancer that utilizes a patient's own dendritic cells loaded with their tumor-associated antigens with the goal of achieving a targeted immune response against the tumor with a low incidence of side effects. Last October, NWBO </font> <font> announced long-term follow-up data </font> <font> for DCVax-Brain from previously conducted studies and NCT00045968 is the ClinicalTrials.gov identifier for a Phase 2 study in patients with GBM that is not yet recruiting patients. </font> <font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials (currently tracking over 225 companies and 350 entries), which are tracked in the actively managed HavRx Regulatory Catalyst Index. NEW! 50% discount promo codes are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font> <font> Disclosure: Long CLDX, IMUC </font>
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November 09
ImmunoCellular (OTC: IMUC.OB): Griffin Maintains Buy Rating with $3.25 Target
This pick is about: ImmunoCellular Therapeutics Ltd. (IMUC)
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$0.0 (11/09/09)
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| Closed: |
04/03/2010
@ $0.0
( n/a)
in
145 days)
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IMUC is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs). 1.) The Phase I trial of ICT-107 yields tantalizing efficacy data against glioblastoma and with no safety issues. 2.) Roche (OTC: RHHBY.PK) licenses ICT-69 antibody therapy for multiple myeloma and ovarian cancer; more deals in the making. 3.) Therapies advance in the R&D pipeline, and the Company is preparing for new clinical trials. 4.) We reiterate our BUY recommendation and maintain our target price of $3.25 per share. Early next year (1Q10 which ends 3/31/10), IMUC expects to make an IND filing with the FDA for permission to begin human clinical trials for a Phase 1 study of its off-the-shelf cancer stem cell vaccine candidate (ICT-121). IND Filings for ICT?121 are expected for Brain Tumors in US or Europe during 1Q10 while IND Filings for ICT?121 for Pancreatic Cancer are expected in the US or Europe during 3Q10. The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my <font> 22 ProActive HavRx stock indexes </font> . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes. Disclosure: Long IMUC.OB
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December 23
Mentor Capital / QI, Cancer Vaccine Investing Update Report
This pick is about: Celldex Therapeutics Inc (CLDX)
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$4.41 (12/23/09)
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04/03/2010
@ $6.17
(+39.91%
in
101 days)
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The <font> BioMedReports.com stock research download section </font> has been updated today to reflect my new 22-page PDF report and overview of Mentor Capital (OTC: MNTR.PK), Quantum Immunologics (QI) (privately held), and clinical / regulatory updates for several other companies in the cancer vaccine that are outlined below and summarized in the report. Mentor Capital is a public-traded, private equity firm that specializes in acquisitions. The Company provides passive equity funding and liquidity to smaller companies and owners by investing in select shelf IPOs, public, and private companies to provide public market access to owners of small private companies. In early July 2009, as the first of four steps leading to a potential merger and name change, MNTR.PK acquired a 20% ownership stake in the privately-held cancer vaccine company, QI. In mid-December, Mentor Capital announced plans to launch an actively managed <font> Cancer Immunotherapy (CI) Index </font> fund shortly after New Year's Day that will be based on the underlying Mentor Capital CI Index, which has gained 45% on an equal-weight basis since its inception on 7/10/09. MNTR.PK intends to invest a significant portion of the cash proceeds from the exercise of warrants which are currently outstanding on a stepped-price basis at $1, $3, $5, and $7 per share. The Company also announced that $1.2 million each in initial seed funding for the CI Index will be provided in approximately equal parts by Mentor Capital management, WellCap Partners (fund administrator) , and MNTR.PK Series C (previously at $5) warrant holders. Mentor Capital currently has about 900,000 shares outstanding and the Series C warrants were called last week at $0.65 (for a period of 45 days) to provide approximately one-third of the initial seed funding for the CI Index fund. QI's approach to cancer immunotherapy involves sensitizing the dendritic cells (which present foreign antigens to the immune system) from a patient's blood to educate and direct the immune system to attack malignant tumor cells in a targeted effort to eradicate or stabilize the disease. This integrated approach to the treatment, diagnosis, and monitoring of cancer is being developed to create novel, individualized products and services that offer a high rate of efficacy and minimal side effects by harnessing the innate power of the immune system in a targeted manner against the disease. Ø QI expects to complete enrollment of all 27 patients in the ongoing Phase I/II trial for metastatic breast cancer by the end of 1Q10, at which time preliminary data is expected from the initial cohort of patients that will be discussed with the FDA to design a pivotal, Phase IIb/III clinical trial that could begin in late 2010. Ø QI is the exclusive licensee of various patent rights in the U.S., Europe, and other countries for the use of OFA to diagnose, monitor, and treat multiple types of cancer. The OFA-iLRP patents are the by-product of 20 years and $30 million of research primarily funded by the National Institute of Health / National Cancer Institute. In addition, QI has filed two provisional patents related to OFA peptides, further expanding QI’s patent estate. Dendreon (NASDAQ: DNDN) follows a similar approach to QI, except that Dendreon is initially focused on the treatment of prostate cancer as it prepares to become a commercial-stage company with the possible early to mid 2010 launch of Provenge (sipuleucel-T). Provenge is derived from a patient's own immune system (dendritic cells, hence the name Dendreon) and is poised (upon FDA approval) to become the first of a new class of therapeutics called active cellular immunotherapies (ACI) which are also referred to as therapeutic cancer vaccines. In November 2009, Dendreon announced that it completed the submission of an amended Biologics License Application (BLA) for Provenge, seeking FDA approval for men with metastatic castrate-resistant prostate cancer (CRPC). The amended BLA includes data from the IMPACT trial, which was conducted under a Special Protocol Assessment (SPA) with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC. Provenge is currently available through several ongoing clinical trials, including OpenACT (an open label trial enrolling men with metastatic CRPC), ProACT, and NeoACT. In late April 2009, Dendreon announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011. On 11/20/09, the FDA accepted Dendreon’s amended BLA as a complete response and set a PDUFA action date of 5/1/10 for an expected FDA decision for Provenge. In mid-November, Oncothyreon (NASDAQ: ONTY) reported its quarterly results and provided a development pipeline update. Stimuvax (BLP25 liposome vaccine, L-BLP25) is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, which is a glycoprotein antigen widely expressed on common cancers, including lung cancer, breast cancer, prostate cancer and colorectal cancer. ONTY’s partner for the development of Stimuvax, Merck KGaA / Serono (OTC: MKGAY.PK), is actively enrolling patients in two global Phase 3 trials. Initiated in February 2007, START is a randomized, double-blind, placebo-controlled study in patients with documented unresectable stage III non-small cell lung cancer who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. NCT00409188 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of December 2010 for final data collection of the primary outcome measure with an estimated enrollment of 1,322 patients. STRIDE is a randomized, double-blind, placebo-controlled study in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer, initiated in June 2009 with a primary endpoint of progression-free survival (PFS). NCT00925548 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of September 2012 for final data collection of the primary outcome measure with an estimated enrollment of 909 patients. ONTY is also developing BGLP40 as a completely synthetic MUC1-based liposomal glycolipopeptide cancer vaccine for potential use in several cancer indications. The antigen incorporated in BGLP40 combines carbohydrate and peptide determinates in a multi-epitope vaccine that evokes both cell- and antibody-mediated immune responses against major cancer-associated targets expressed on adenocarcinomas. The vaccine also includes the fully synthetic PET-lipid A adjuvant which is proprietary to ONTY, which currently intends to substantially complete the pre-clinical development of BGLP40 in 2010, with the goal of initiating clinical development in 2011. Merck KGaA / Serono has a right of first negotiation with respect to the development or marketing of BGLP40. Celldex Therapeutics (NASDAQ: CLDX) is developing CDX-110 (PF-04948568) along with Pfizer (NYSE: PFE) as a cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). CDX-110 is currently being evaluated in a Phase 2 study (ACT III) of CDX-110 in patients with newly diagnosed GBM. NCT00458601 is the ClinicalTrials.gov entry for this study (last updated on 11/20/09) and April 2010 is the estimated date for data collection for the primary outcome of progression-free survival status at 5.5 months from the date of first dose. The estimated study completion date is Nov 2010. ImmunoCellular Therapeutics (IMUC.OB) is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, therapeutic cancer stem cell vaccine (ICT-121) that targets a protein marker called CD133 that is over-expressed on cancer stem cells. The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months. ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers. IND Filings for ICT?121 are expected for brain tumors in during 1Q10 while IND Filings for ICT?121 for pancreatic cancer are expected during 3Q10. In late October, IMUC presented new data for its therapeutic cancer vaccine product candidate ICT-107 as an update to preliminary data that was presented at ASCO 2009 in late May and included a median PFS survival time (defined as the time between surgical tumor removal and tumor recurrence) in the 16 newly diagnosed patients enrolled in the trial was 19 months, which is over 12 months longer than the historical PFS of just 6.9 months. In addition, seven of the 16 patients continue to show no signs of tumor recurrence while three of the patients have gone more than two years without disease progression. ICT-107 targets six glioma-specific peptides, including targets that are highly expressed on cancer stem cells and IMUC expects to sign a licensing deal to fund further clinical development of ICT-107 during 2010. In early October, Inovio Biomedical (AMEX: INO) announced interim safety / immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. The vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered. The vaccine is delivered using Inovio’s proprietary CELLECTRA intramuscular electroporation delivery device. Inovio expects to report interim data relating to safety and levels of immune responses (immunogenicity) from the second and third dose groups during 1H10 and plans to initiate a Phase 2 trial in late 2010. This Phase I clinical trial is designed to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer. This dose-escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose. Northwest Biotherapeutics (OTC: NWBO.OB ) is developing DCVax-Brain as a personalized therapeutic cancer vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax-Brain is comprised of a patient's own dendritic cells that have been activated to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells. The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells in order to activate the patient's dendritic cells, which are subsequently injected back into the patient under the skin in the upper arm. The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax-Brain an off-the-shelf product for that patient throughout the treatment period, following the initial collection, preparation, and manufacturing process. NCT00045968 is the ClinicalTrials.gov identifier for a Phase 2 study evaluating DCVax-Brain in GBM patients which currently has an estimated date of December 2011 for final data collection for the primary outcome measure. On 10/21/09, NWBO.OB reported that DCVax-Brain has begun a 240-patient Phase 2 clinical trial with 13 trial sites at medical centers across the U.S. and stated that the trial is not currently enrolling patients, but expects to resume doing so soon. In late October, MannKind Corp. (NASDAQ: MNKD) announced that results of two Phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for Phase 2 studies. MKC1106-MT is an active cancer immunotherapy product candidate consisting of three components, a DNA plasmid and two synthetic peptides, each of which is administered separately by the unique route of intranodal injection and together are designed to target two tumor-specific antigens that are commonly expressed by melanoma tumor cells. Findings reveal an immune response rate of greater than 40%, defined as the percentage of patients who showed elevated numbers of antigen specific T cells in the blood upon immunization, and preliminary evidence of clinical benefit. Of the 18 patients treated, 14 had visceral metastases and the remaining four had metastases confined to the lymphatic system. MKC1106-PP is a similar agent being developed by MNKD that is designed to target two specific tumor antigens commonly expressed by various solid tumor cells. An immune response rate of 60% was observed and, of the 26 patients treated, seven patients achieved clinical responses defined as partial response (RECIST), change in PSA doubling time or stable disease for at least six months. In late October, Antigenics (NASDAQ: AGEN) announced updated Phase 2 data for Oncophage (vitespen) for recurrent high grade glioma (brain cancer) for the first 20 patients treated, demonstrating a median survival of 10.1 months. Survival data continues to accrue on all patients in the study and thus far, six patients (30%) have survived at or beyond 12 months. The Phase 2 single-arm trial is designed to enroll about 50 patients with recurrent high-grade glioma. Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines and then receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. The Brain Tumor Research Center at the University of California, San Francisco (UCSF), has initiated an additional Phase 2 clinical trial of Oncophage in combination with the standard of care (radiation + Temodar) for newly diagnosed glioma patients to evaluate median overall survival, progression-free survival and immune response. CEL-SCI Corp. (AMEX: CVM) is awaiting validation of its cold fill contract manufacturing facility (which will also manufacture Multikine) before initiating a pivotal Phase 3 clinical trial of Multikine. The pivotal Phase 3 study is designed as an open-label, randomized, global multi-center trial to evaluate the effects of Multikine plus standard of care (SOC) therapy (surgery + radiation or surgery + concurrent chemo / radiation) in subjects with advanced primary squamous cell carcinoma of the oral cavity versus the SOC therapy only. The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to SOC as measured by overall survival with secondary objectives that include evaluating the effects of Multikine on the cumulative incidence of local / regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, and confirming safety of the treatment. About 800 patients are expected to be enrolled in the study on a global basis that includes North / South America, Europe, and Asia. In late May, Biovest (OTC: BVTI.PK) announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase 3 clinical study has shown that BiovaxID (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin’s lymphoma. The study found that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of 47%. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine. In late June, Biovest announced that BiovaxID is available on a named-patient (compassionate-use) basis in Europe and will be supplied by Idis Limited to European healthcare professionals for the treatment of follicular non-Hodgkin’s lymphoma and potentially for other B-cell blood cancers such as chronic lymphocytic leukemia, mantle cell lymphoma and multiple myeloma. Omnimmune (OTC: OMMH.OB) has licensed rights to platform monoclonal antibody (MAb) technologies and a multivalent cancer vaccine targeting two epitopes of HER-2 (Human Epidermal Growth Factor Receptor-2) (HER-2 is found in about 15-20% of breast cancers and is associated with increased disease recurrence and a worse prognosis). The cancer vaccine has completed a Phase 1 NCI-sponsored clinical trial. Omnimmune plans to sponsor Phase 2 and 3 trials and market the vaccine in collaboration with others. Omnimmune plans to develop prophylactic and therapeutic vaccines, monoclonal antibodies, and gene-based products, which target a hormone called human chorionic gonadotropin (hCG). On 12/9/09, Immunovaccine (TVE: IMV.V) announced FDA clearance for its Investigational New Drug (IND) application to begin human studies of its therapeutic cancer vaccine (DPX-0907). DPX-0907 is the Company’s lead therapeutic cancer vaccine candidate which uses the DepoVax platform to deliver tumor specific antigens. DPX-0907 is designed to cause a depot effect that has the potential to stimulate the immune system to seek out and destroy cancer cells in patients with breast, ovarian and prostate cancer. The Phase 1 clinical trial for DPX-0907 will be conducted at five sites in the US and is on track to begin enrolling patients with breast, ovarian, and prostate cancers by the end of 1Q10. The Phase 1 clinical trial will evaluate the safety and tolerability of the DepoVax delivery system and seven tumor-associated antigens. The activity of DPX-0907 has been demonstrated in preclinical models whereby the vaccine produced a specific cellular immune response that was superior to immune responses achieved with other oil depot vaccines. Preclinical research also reveals DPX-0907 does not induce regulatory T-cell immune suppression, therefore enabling a longer lasting anti-tumor immune response. Disclosure: Long CLDX, IMUC.OB, MNTR.PK, QI
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October 28
YM BioSciences (AMEX: YMI): Griffin Reiterates Buy Rating, Ups Price Target to $5.50
This pick is about: YM BioSciences Inc (YMI)
| Rating: |
$1.07 (10/28/09)
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| Closed: |
04/02/2010
@ $1.19
(+11.21%
in
156 days)
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On 10/28/09, Griffin Securities issued a research report, reiterating its buy rating on YM BioSciences (AMEX: YMI) (TSX: YM.TO) and increasing the 12-month price target to $5.50 per share. Below is a summary of the rationale behind the updated buy rating and new price target. 1.) YMI has 11 global Phase II / III trials ongoing for nimotuzumab (nimo), which is an EGFR-targeting monoclonal antibody with best-in-class potential in an established class of billion dollar drugs with only two other antibodies available that target EGFR, including Erbitux and Vectibix 2.) YMI has a strong development partner in Japan, Daiichi Sankyo (OTC: DSKYY.PK), that provides both validation for nimo’s commercial potential and funding for clinical trials in Japan with YMI receiving a royalty on sales, milestone payments and the use of clinical data that is generated. Data is expected from Daiichi’s Phase II trial of nimo with chemo / radiation as a first-line treatment for non-small-cell lung cancer (NSCLC) and data from Daiichi’s Phase II trial of nimo in recurrent gastric cancer during 1H10. 3.) Data from a Phase II randomized trial in head and neck cancer for nimo demonstrates comparable efficacy to Erbitux in high-EGFR expressing cells without the numerous severe toxicities of Erbitux, such as severe rash. 4.) The Company’s proposed all-stock acquisition of Cytopia Ltd. (ASX: CYT.AX) includes a promising clinical stage portfolio to YMI at a favorable valuation (would involve the issuance of approximately 7.2 million new shares of YMI stock). CYT997 is currently in a Phase II trial in glioblastoma multiforme (GBM) and a Phase II trial in multiple myeloma. Results are expected from the GBM Phase II study in mid-2010. In addition, the estimated impact on YMI’s cash burn rate from this acquisition is minimal at $1 million in 2010 and $3 million in 2011 for the additional upside potential and pipeline expansion that is provided. 5.) YMI enjoys a solid balance sheet with approximately US$36 million in cash / equivalents as of mid-year, which provides ample resources to support further clinical development of the Company’s key programs. Disclosure: No positions
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November 22
Navigating the Minefield of Micro-Cap Biotechs
This pick is about: ArQule Inc. (ARQL)
| Rating: |
$2.85 (11/22/08)
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| Closed: |
03/31/2010
@ $7.11
(+149.47%
in
493 days)
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 The accompanying table includes 52 companies with market caps below the $150M minimum for inclusion in the ETF Innovators [ETFI] Emerging Bio-Pharma Index . While the performance is terrible with an average loss of nearly 50%, keep in mind that several buyouts in the out-of-favor micro-cap biotech space have been announced over the past year with 100%-plus takeover premiums, including under-the-radar names such as: 1.) SGX Pharma (SGXP) was acquired for $64M cash by Eli Lilly (LLY) for its cancer drug discovery platform 2.) Kosan Biosciences (KOSN) was acquired by Bristol-Myers (BMY) for its cancer drug pipeline 3.) Barrier Therapeutics (BTRX) was acquired by privately-held Stiefel Labs 4.) Pfizer's (PFE) $164M cash buyout of cancer drug developer Coley Pharma (COLY) 5.) The most recent and extreme example includes GlaxoSmithKline's (GSK) $57M buyout of Genelabs (GNLB) for an astounding premium of over 400% for the latter's hepatitis C clinical development assets The common theme for these buyouts includes spending a very small amount of money relative to the huge size of the acquiring big pharma companies to acquire assets and expertise for early stage drug discovery and development – with three of the five aforementioned deals focused on cancer drug development. As a starting point for further investment research, companies on the list of 52 with market caps below $150M which have cancer drug candidates and/or discovery platforms include Cytokinetics (CYTK), ArQule (ARQL), Immunomedics (IMMU), Infinity Pharma (INFI), Ardea Biosciences (RDEA), Xoma Ltd. (XOMA), SuperGen (SUPG), Ariad Pharma (ARIA), Celldex Therapeutics (CLDX), and Vical (VICL).
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February 26
Big Pharma Goes Generic
This pick is about: Lannett Company Inc (LCI)
| Rating: |
$5.2 (02/26/09)
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| Closed: |
03/30/2010
@ $4.42
(-15.00%
in
397 days)
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 Sanofi-Aventis (SNY) is now the 11 th largest generic drug maker in the world following its successful acquisition of Czech generic drug company Zentiva. As $70B in brand drug patents are set to expire through 2012, big pharma companies are hedging their bets through generic drug divisions, including Pfizer (PFE) - Greenstone, Novartis (NVS) - Sandoz, and the recently announced Merck (MRK) BioVentures which will specialize in bio-generics. Elsewhere in the industry, India-based Ranbaxy (RANBAXY.NS) lost about 20% of its market value today on word the FDA would not review new generic drug product applications from one of the Company's facilities amid charges of fraud that involved falsifying shelf life data. The 12 U.S. listed generic drug makers included in the ETF Innovators Global Generic Drug Index include Mylan Labs (MYL), Caraco Pharma (CPD), Lannett (LCI), Hi-Tech Pharmacal (HITK), Teva Pharma (TEVA), Taro Pharma (TAROF.PK), Impax Labs (IPXL.OB), Dr. Reddy's Lab (RDY), Par Pharma (PRX), Perrigo (PRGO), Momenta Pharma (MNTA), and Watson Pharma (WPI). Two major privately held generic drug makers are currently on the sell block, including Actavis and Ratiopharm, while Taro is involved in a hostile tender offer by India's Sun Pharma (SUNPHARMA.NS) - which already owns a majority stake (76%) in Caraco. In addition, seven of the 12 U.S. listed generic drug makers have market caps less than $500M, making them takeover targets for the larger players in the industry such as TEVA and MYL or big pharma companies interested in entering the space. Favorable growth trends for the generic drug industry include nearly $70B in brand name drug sales with patent expirations through 2012, a push to increase generic substitution rates from 65% of all prescriptions dispensed to over 70%, continued industry consolidation of small and mid-cap companies. Also, three generic drug firms (TEVA, MYL, and WPI) have recently posted strong operating results and the basket of a dozen U.S. listed generic drug stocks lost about 10% on an equal-weight basis in the past year. This performance compares favorably to the big pharma dominated Pharmaceutical HOLDRs (PPH) and the Healthcare Sector SPDR (XLV) - with each of these funds down about 24% in the past year. The global generic drug industry is an excellent candidate for a new ETF idea as the industry fundamentals and consolidation make for a compelling investment theme. |
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November 19
Epinex Diagnostics: A New Paradigm for Diabetic Testing
This pick is about: Abbott Laboratories (ABT)
| Rating: |
$53.18 (11/19/09)
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| Closed: |
03/30/2010
@ $52.51
(-1.26%
in
131 days)
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Epinex Diagnostics Inc. (click on preceding link for the Company's News Room page) is a private company that is dedicated to the development of innovative point-of-care technologies using rapid diagnostic tests. Epinex has developed a proprietary platform for rapid tests that apply existing immunoassay strips and biosensors to create unique quantitative diagnostic tests. Advantages of the Epinex Quantitative Immunoassay System for Point-of-Care Testing include the following: 1.) Rapid: Results within minutes. 2.) Quantitative: Yields a precise value, not just "yes" or "no". 3.) Easy to use: No training required. 4.) Cost effective: Point-of-care testing reduces overall cost to the healthcare system. 5.) High Sensitivity: Results comparable to the "gold standard" ELISA test. The Epinex G1A TM (glycated albumin, which is a measure of average blood sugar control over the previous month) Test is the first of a series of diagnostic monitoring tests based on the Company's proprietary detection platform technology and dual-mode test reader. Future rapid tests under development by Epinex include infectious diseases, other metabolic disorders, coronary artery disease, rheumatoid arthritis, Down Syndrome, and neonatal HIV.   Albumin is a protein found in the blood that can be measured with precision and has a turnover or replacement time of 2-3 weeks. Like many proteins in the body, albumin can become altered or glycated. High levels of glycated albumin have been directly linked to major complications of diabetes such as retinopathy (blindness) and nephropathy (kidney failure) through the damage caused to small blood vessels by the altered protein. It is also a marker for other types of diabetes complications. More than 25 years of clinical research has proven that monthly measurement of glycated albumin is a superior technology to monitor and control glycation. The Epinex G1A TM Rapid Diabetes Monitoring Index Test is a monthly test for the control of glycation. The test is composed of the G1A TM reader and a proprietary dual-channel test cassette, which is able to simultaneously test for glycated albumin and total albumin. A drop of whole blood is placed on the sample well of the cassette and the cassette is inserted into the reader device. Based on the Company's platform technology, the G1A TM reader automatically quantifies the analyte concentrations on the cassette and gives the G1A TM Index, the ratio of glycated albumin to total albumin in serum.   The G1A TM Index shows how well the patients have controlled their level of glycation over the previous month. Simple to operate, the G1A TM test system can be performed at the point of care without the need for highly trained laboratory technicians. It allows for immediate feedback between healthcare provider and patients, thus facilitating timely therapeutic interventions. The results are stored on the device, providing trend analysis as well as displaying immediate results. The results can be transmitted by means of a computer or wireless connection to a doctor's office or other central data location. The global diabetes epidemic affects an estimated 300 million people worldwide and this number is expected to double by 2030 with an estimated cost of $232 billion. Diabetes is the fifth leading cause of death in the U.S. and fourth leading cause of death on a global basis. Complications of diabetes may include heart disease, blindness, kidney failure, extremity amputations / circulation problems, and neuropathies. The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market is dominated by global, diversified healthcare giants such as Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Roche (OTC: RHHBY.PK) (Accu-Chek), and Bayer (OTC: BAYRY.PK) (Ascenscia). Glycation (binding of excess sugar to proteins such as albumin and hemoglobin) is a major cause of the long-term complications of diabetes and an indicator of the risk of developing those complications. The goal of diabetes monitoring is to control glycation and to avoid the complications of diabetes. This allows diabetics and their health care providers to determine a treatment regimen, to monitor its effectiveness, and to alter it as needed for better overall glucose control. Current diabetes monitoring methods may include periodic doctor visits (e.g. every six months) in addition to multiple tests for monitoring blood sugar levels. Blood glucose monitoring is the most common and frequent means of measuring blood sugar levels on a real-time basis and may be conducted up to four times daily or more via finger prick or alternate site (e.g. forearm) testing by patients. While blood glucose machines are often subsidized or given away free, the test strips are expensive and represent an ongoing cost along with poor patient compliance due to the high frequency of testing and finger pricks that are involved with this method. Glycated hemoglobin (HbA1c) is typically conducted 2-3 times per year and provides a measure of average blood sugar control over the previous 90 days. Disclosure: No positions
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February 26
Expert Panel Recommends FDA Regulation of Tobacco
This pick is about: Lorillard Inc. (LO)
| Rating: |
$60.13 (02/26/09)
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| Closed: |
03/30/2010
@ $74.745
(+24.31%
in
397 days)
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By Mike Havrilla on 2/25/09 The ETF Innovators Global Tobacco Index tracks the performance of the 24 companies listed below which derive the majority of their revenue from the distribution or manufacturing of any type of tobacco product (e.g. cigarettes, cigars, chewing tobacco) or any related supplies (e.g. wrapping papers, tobacco leafs, filters) used directly in the manufacture of tobacco products. The Global Tobacco Index is down by 9.3% to a value of 258,320 and average dividend yield of 4.4% from its starting value of 284,864 on 12/21/08, as compared to losses of 10.3% for the S&P 500 SPDR (SPY) and 10.5% for the Consumer Staples Sector SPDR (XLP). Today, a panel of 26 leading tobacco control researchers and policy experts issued a statement that included a recommendation for FDA regulation of all tobacco products. Other recommendations included regulation of marketing, public education initiatives on the relative risks of products containing nicotine, higher cigarette taxes, increased efforts for programs to help people stop using tobacco products, and stricter regulations of tobacco advertising. The following companies are standouts from the index based on their current valuation and other financial parameters: 1.) highest dividend yields: Vector Group (VGR) = 12.3%, Reynolds American (RAI) = 10%, Altria (MO) = 8.5% 2.) largest market caps: Philip Morris International (PM) = $70B, British American Tobacco (BTI) = $49B, Altria = $32B 3.) biggest stock price increase in the past year: Star Scientific (STSI) = +52% The remaining companies in the Global Tobacco Index include: 1.) Alliance One (AOI) 2.) Bentoel International (Indonesia: RMBA.JK) 3.) Godfrey Phillips (India: GODFRYPHL.NS) 4.) Golden Tobacco (India: GOLDENTOB.BO) 5.) Gudang Garam (Indonesia: GGRM.JK) 6.) Hanjaya Mandala (Indonesia: HMSP.JK) 7.) Imperial Tobacco (UK: IMT.L) 8.) ITC Ltd. (India: ITC.NS) 9.) Japan Tobacco (JAPAF.PK) 10.) JT International (Malaysia: 2615.KL) 11.) Korea Tobacco & Ginseng (KT&G) (033780.KS) 12.) Kothari Products (India: KOTHARIPR.NS) 13.) Lorillard (LO) 14.) RDB Industries (India: RDBIND.BO) 15.) Schweitzer-Mauduit (SWM) 16.) Swedish Match (SWMA.ST) 17.) Universal Corp. (UVV) 18.) Woori Tobacco Sales (Korea: 016670.KQ
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June 30
FDA Calendar Updates: POZN, AZN, SNY, CEPH, APPY, CYTR
This pick is about: Cephalon Inc (CEPH)
| Rating: |
$56.57 (06/30/09)
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| Closed: |
03/29/2010
@ $72.62
(+28.37%
in
272 days)
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Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval. On 6/30/09, AspenBio Pharma (NASDAQ:APPY) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis. This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010. These follow-on trials will be designed to support a 510(k) submission for this rapid assay platform using the ELISA test as a predicate. The rapid assay system represents the format that APPY plans to ultimately commercialize. On 6/30/09, CytRx Corp. (NASDAQ:CYTR) announced that it filed a report (including results from an animal toxicology study) with the FDA in response to the Agency’s partial clinical hold on the Company’s Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). CYTR expects that the FDA will review the report during 3Q09 and stated that the Agency’s partial clinical hold was unrelated to data generated by human studies and arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events. On 6/30/09, Cephalon (NASDAQ:CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to FDA requesting approval of NUVIGIL (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person's internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights. On 6/30/09, Pozen (NASDAQ:POZN) announced the submission of a NDA to the FDA for the marketing approval of VIMOVO (PN 400), the combination of enteric-coated naproxen and immediate-release esomeprazole (currently marketed as Nexium). Pozen and AstraZeneca (NYSE:AZN) entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers. Upon the Agency’s acceptance for filing of the NDA, a $10 million milestone payment from AZN will be payable to Pozen. The estimated PDUFA action date is 4/30/10 for a standard, 10-month review for a possible FDA decision on this NDA. On 6/30/09, Sanofi-Aventis (NYSE:SNY) provided an update on the Company’s R&D division and stated that it is still awaiting a FDA decision for its pending NDA for heart drug Multaq (dronedarone) in the treatment of atrial fibrillation (a type of irregular heartbeat). In March, a FDA panel of cardiology experts recommended that Multaq should be approved with a 10-3 vote and the original PDUFA action date was 4/30/09. Both the Company and analysts are expected Multaq to post annual peak sales over $1 billion (U.S. Dollar) despite FDA Advisory Panel recommendations that the drug (1) should not be used in patients with advanced cases of heart failure (Class III and IV) and (2) SNY cannot claim the drug lowered the risk of death. Disclosure: No positions.
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March 16
Regulatory Catalyst Extreme Trades: $APPA, $APPY $ARIA, $CTIC, $SOMX
This pick is about: Cell Therapeutics Inc (CTIC)
| Rating: |
$1.01 (03/16/10)
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| Closed: |
03/28/2010
@ $0.64
(+36.63%
in
12 days)
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The actively managed HavRx Regulatory Catalyst Index tracks the performance of select companies which meet any of the following requirements: (1) pending new drug, biological agent, medical device, or diagnostic product applications at the FDA; (2) pending pivotal clinical trial results that are designed to support a new filing or resubmission for FDA marketing clearance; and (3) pending early stage clinical study results. Categories (1) and (2) will comprise two-third (67%) or greater of all index components while companies with pending early stage clinical trial results will comprise one-third (33%) or less of all index components. As of 3/15/10, statistics for the <font> Regulatory Catalyst Index </font> are outlined below and includes daily updates in the evening (between 6-8pm ET) on regular market days which are available to view, download, and print at the subscriber home page. The daily Regulatory Catalyst Index Updates are available in four versions, sorted by company name (A-Z), stock price (low-high), expected binary event catalyst date (oldest-newest), and the date each entry was last updated (newest-oldest). (1) 255 total entries to track select pending binary event data (FDA decisions, clinical trials) (2) 170 companies tracked with 92 active index components (3) 130 companies under $10 per share and 95 companies under $5 per share 1.) AP Pharma (NASDAQ: APPA) ($1.50, $59 million) has a pending FDA decision for a novel, long-acting formulation of already approved ingredient (granisetron is currently marketed as Kytril), known as APF530 (long-acting granisetron) with a FDA decision expected 3/18/10 for this Section 505(b)(2) NDA 2.) Somaxon Pharma (NASDAQ: SOMX) ($4.11, $97 million): Silenor (doxepin) NDA is seeking approval for the treatment of insomnia. FDA has accepted its response as a Class I resubmission (60-day review period) for expected decision by 3/21/10. 3.) Cell Therapeutics (NASDAQ: CTIC) ($1.01, $580 million): Pixuvri (pixantrone) Injection has a PDUFA action goal date of 4/23/10 and advisory panel meeting scheduled for 3/22/10. This NDA is seeking approval of pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL), expects to file MAA in EU mid-2010, NerPharMa manufctg facility was approved by FDA 3/8/10. 4.) Ariad Pharma (NASDAQ: ARIA) ($3.32, $362 million): Pivotal, Phase 3 SUCCEED trial for oral ridaforolimus has an expected interim analysis around the end of 1Q10 with final data analysis expected 2H10 in patients with metastatic soft-tissue and bone sarcomas. 5.) AspenBio Pharma (NASDAQ: APPY) ($2.26, $85 million): AppyScore (blood-based diagnostic test appendicitis) clinical trial expected to complete enrollment in March and support a new 510(k) submission that may occur 2H10, contingent upon results in this study. mikehavRx.com Index Updates is a premium service that provides investors with time-saving information and updates on unique global baskets of stocks that are organized and managed within the 18 HavRx Stock Indexes outlined below that are being tracked at the Investars YOU website since June 2009. Please visit <font> www.mikehavRx.com </font> for more details on my new publishing company, website, and premium service. Disclosure: No positions
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March 12
mikehavRx.com News Bytes: $DCTH, $TRA, $POT, $SUPG, $ACCP.OB, $AMLN
This pick is about: Delcath Systems Inc (DCTH)
| Rating: |
$5.87 (03/12/10)
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| Closed: |
03/28/2010
@ $7.26
(+23.68%
in
16 days)
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HavRx Global Crop Science Index: Potash (NYSE: POT) is poised to open trading at new highs after posting strong earnings and upping its guidance. Meanwhile, Yara International (OTC: YARIY.PK) has withdrawn its bid for Terra Industries (NYSE: TRA), which will be acquired by CF Industries (NYSE: CF). In addition, Agrium (NYSE: AGU) has dropped its hostile bid for CF. <font> Delcath Systems (NASDAQ: DCTH) is an emerging, small-cap medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath's Percutaneous Hepatic Perfusion (PHP) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient's entire body to the anti-cancer drugs, representing an elegant solution that promises to increase the effectiveness of approved anti-cancer drugs while reducing systemic side effects. </font> <font> DCTH conducted an update conference call today and still expects pivotal study results in April. The pending FDA filing will be based on these results with Fast Track status and rolling submission to expedite the process while a filing for CE Mark (Europe) clearance as a Class III medical device is now expected by year-end. </font> <font> Amylin Pharma (NASDAQ: AMLN), Eli Lilly (NYSE: LLY), and Alkermes (NASDAQ: ALKS) have a financial stake in a pending FDA decision that is expected today for a new once-weekly formulation of diabetes drug Byetta (exenatide LAR). </font> <font> Access Pharma (OTC: ACCP.OB) has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone or hGH, erythropoietin or EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics (sRNAi), and monoclonal antibodies). On Thursday, Access announced that it received reports from its two bio-pharmaceutical collaborators for oral insulin, which independently confirmed previous results by the Company for oral bio-availability in preclinical animal models of greater than 80% as compared to subcutaneous injections of insulin. </font> <font> Access reported several ongoing negotiations with additional companies that are interested in its Cobalamin Oral Drug Delivery Technology while simultaneously evaluating options for advancing oral insulin to proof-of-concept studies in humans as soon as possible. Based upon previous guidance, Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000). </font> <font> Earlier this morning, Eisai Inc. (OTC: ESALY.PK) announced FDA approval for a five-day dosing regimen for anti-cancer drug Dacogen (decitabine) to treat patients with myelodysplastic syndromes (MDS). Dacogen was approved by FDA in May 2006 for a three-day regimen and developed by SuperGen (NASDAQ: SUPG) and MGI Pharma (which was since acquired by Eisai). </font> <font> mikehavRx.com Index Updates is a premium service that provides investors with time-saving information and updates on unique global baskets of stocks that are organized and managed within the 18 HavRx Stock Indexes outlined below that are being tracked at the Investars YOU website since June 2009. Please visit </font> <font> www.mikehavRx.com </font> <font> for more details on my new publishing company, website, and premium service. </font> <font> Disclosure: Long ACCP.OB, DCTH </font>
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Investment Style:
Aggressive
[?]
The investor is willing to take risks to achieve high returns from portfolio. Investor's holding consists of speculative stocks that will produce massive gains or losses and/or the trading strategy is focused more on short term profits rather than long term appreciation
Avg exp holding time:
384.29 days
Website:
www.BioRunUp.com
About Me:
I am a pharmacist, writer, marathon runner, and investor. Check out the Ultimate Guide to Biotech Sto
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I am a pharmacist, writer, marathon runner, and investor. Check out the Ultimate Guide to Biotech Stocks book and DVD at http://www.biotechguides.com
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