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 Mike Havrilla     www.BioRunUp.com     Graphic_subscribe   

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    Community Rank: Principal (7000 pts)  |  Member since 07/15/2008
Mikerun
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June 09

NeuroSearch Experimental Obesity Drug to Begin Phase 3 Trials
Mikerun
   Mike Havrilla   06/09/09  

This pick is about: VIVUS Inc. (VVUS)
Rating:   Positive   $5.61 (06/09/09)
Closed:   07/03/2009 @ $5.9 (+5.17% in 24 days)
9 pts


 
As a trio of U.S. small-cap drug makers await crucial Phase 3 results later this year; NeuroSearch (CPH:NEUR) (PINK:NEUSF) is preparing to advance its own experimental weight loss drug to the final stage of clinical development following a successful End of Phase 2 meeting with the FDA which was announced earlier this week. Arena Pharma (NASDAQ:ARNA), Vivus (NASDAQ:VVUS), and Orexigen Therapeutics (NASDAQ:OREX) are all awaiting Phase 3 clinical trial data expected during 3Q09 for their experimental weight loss drugs to support NDA filings for FDA approval, which are summarized and tracked in the <font> BioMedReports.com FDA Calendar </font> .
 
 
On 6/8/09, NeuroSearch announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as a novel treatment for obesity (weight management). The FDA endorses the overall Phase 3 plan for tesofensine in obesity, including the filing of an NDA based on 12 months safety and efficacy data. NeuroSearch will now finalize Phase 3 preparations and an SPA (Special Protocol Assessment) request for submission to the FDA, while continuing discussions with potential license partners.
 
The main conclusions from the End of Phase II discussions with the FDA include the following: (1) The proposed dose regimen of 0.25 mg or 0.5 mg tesofensine daily in Phase III was endorsed. (2) The proposed pivotal Phase 3 program for tesofensine in weight management was endorsed by the FDA and will consist of four placebo-controlled clinical studies, comprising a total of approximately 5,700 obese patients with and without co-morbidities (such as Type 2 diabetes, hypertension and dislipidemia). (3) Two of the four trials are powered to show superior weight loss effectiveness for tesofensine compared to sibutramine (marketed as Reductil and Meridia). (4) The safety and efficacy assessment within and across the Phase 3 studies and the filing of the NDA for tesofensine for weight management based on 12 months data were also endorsed by the FDA.
 
Earlier results from a Phase II Proof of Concept study with tesofensine in obesity, TIPO-1, has shown a placebo-corrected average weight loss of approximately 10% after 24 weeks of daily treatment with 0.5 mg tesofensine. The results from TIPO-1 have been published in The Lancet (The Lancet, Volume 372, Issue 9653, Pages 1906-1913, 29 November 2008) with the conclusion that tesofensine produces a weight loss at least twice that of currently approved anti-obesity drugs. The safety data base for tesofensine includes more than 1,500 patients having been exposed to treatment with tesofensine and hereof more than 1,300 on relevant dosing.
 
Disclosure: No positions.


NeuroSearch Experimental Obesity Drug to Begin Phase 3 Trials
Mikerun
   Mike Havrilla   06/09/09  

This pick is about: Orexigen Therapeutics Inc. (OREX)
Rating:   Negative   $3.92 (06/09/09)
Closed:   07/03/2009 @ $5.67 (-44.64% in 24 days)
9 pts


As a trio of U.S. small-cap drug makers await crucial Phase 3 results later this year; NeuroSearch (CPH:NEUR) (PINK:NEUSF) is preparing to advance its own experimental weight loss drug to the final stage of clinical development following a successful End of Phase 2 meeting with the FDA which was announced earlier this week. Arena Pharma (NASDAQ:ARNA), Vivus (NASDAQ:VVUS), and Orexigen Therapeutics (NASDAQ:OREX) are all awaiting Phase 3 clinical trial data expected during 3Q09 for their experimental weight loss drugs to support NDA filings for FDA approval, which are summarized and tracked in the <font> BioMedReports.com FDA Calendar </font> .
 
 
On 6/8/09, NeuroSearch announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as a novel treatment for obesity (weight management). The FDA endorses the overall Phase 3 plan for tesofensine in obesity, including the filing of an NDA based on 12 months safety and efficacy data. NeuroSearch will now finalize Phase 3 preparations and an SPA (Special Protocol Assessment) request for submission to the FDA, while continuing discussions with potential license partners.
 
The main conclusions from the End of Phase II discussions with the FDA include the following: (1) The proposed dose regimen of 0.25 mg or 0.5 mg tesofensine daily in Phase III was endorsed. (2) The proposed pivotal Phase 3 program for tesofensine in weight management was endorsed by the FDA and will consist of four placebo-controlled clinical studies, comprising a total of approximately 5,700 obese patients with and without co-morbidities (such as Type 2 diabetes, hypertension and dislipidemia). (3) Two of the four trials are powered to show superior weight loss effectiveness for tesofensine compared to sibutramine (marketed as Reductil and Meridia). (4) The safety and efficacy assessment within and across the Phase 3 studies and the filing of the NDA for tesofensine for weight management based on 12 months data were also endorsed by the FDA.
 
Earlier results from a Phase II Proof of Concept study with tesofensine in obesity, TIPO-1, has shown a placebo-corrected average weight loss of approximately 10% after 24 weeks of daily treatment with 0.5 mg tesofensine. The results from TIPO-1 have been published in The Lancet (The Lancet, Volume 372, Issue 9653, Pages 1906-1913, 29 November 2008) with the conclusion that tesofensine produces a weight loss at least twice that of currently approved anti-obesity drugs. The safety data base for tesofensine includes more than 1,500 patients having been exposed to treatment with tesofensine and hereof more than 1,300 on relevant dosing.
 
Disclosure: No positions.


June 08

FDA Calendar Updates: MITI, KERX, GSK, DYAX, ARNA, PGNX
Mikerun
   Mike Havrilla   06/08/09  

This pick is about: Arena Pharmaceuticals Inc (ARNA)
Rating:   Positive   $4.94 (06/08/09)
Closed:   07/03/2009 @ $4.85 (-1.82% in 25 days)
9 pts


Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of about 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 6/8/09, Micromet (NASDAQ:MITI) announced the presentation of Phase 2 clinical data of the BiTE® antibody blinatumomab (MT103), which showed a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease. Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells. The patients included in this Phase 2 study were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow -- so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD. Currently, 13 of 16 (81% of evaluated patients) have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study and MITI will discuss a pivotal ALL program with regulatory authorities later in the year.
 
On 6/8/09, Keryx Biopharma (NASDAQ:KERX) announced results of its Phase 2 study of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on thrice weekly hemodialysis. The top line efficacy and safety results from this Phase 2 study were submitted to the FDA, and discussed at a recent face to face meeting with the Division of Cardiovascular and Renal Drug Products. The FDA also reviewed the final reports for the 90-day rat and 16-week canine toxicology studies. The FDA indicated that the results of the Phase 2 study and the toxicology studies were adequate to support entry into a Phase 3 program. Keryx is in the process of finalizing the Phase 3 program in consultation with the FDA.
 
On 6/7/09, GlaxoSmithKline (NYSE:GSK) announced new Phase 2 clinical trial data demonstrating that the Company's investigational type 2 diabetes treatment Syncria (albiglutide) significantly reduced blood glucose levels and provided weight loss across weekly, bi-weekly and monthly dosing. In the study, dose-dependent reductions in A1C (a measure of how well blood sugar is being controlled over time) with albiglutide 30 mg weekly, 50 mg bi-weekly, and 100 mg monthly were 0.9%, 0.8% and 0.9% respectively. The A1C reduction by placebo was 0.2% and by open-label exenatide (marketed as Byetta) was 0.5%. Weight loss (0.9 to 1.8 kg) was observed across all doses. The most frequently reported adverse events included nausea, vomiting and headache.
 
At the 30 mg weekly dose, fewer than 10% of patients experienced nausea and vomiting, which subsided after week eight. GLP-1 is a peptide that acts throughout the body to help maintain normal blood sugar levels and to control appetite. Albiglutide is the only medication which fuses modified human GLP-1 to human albumin so that it has an extended duration of action that allows for weekly or even less frequent injections. The Phase 3 clinical development program for albiglutide (evaluating the 30mg weekly dose) began with five studies in early 2009 and is expected to last 2-3 years.
 
On 6/8/09, Dyax Corp. (NASDAQ:DYAX) announced today that the FDA accepted the Company’s submission in response to the FDA’s March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax’s BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09.
 
Below are two biomed stocks on the move today as a result of clinical trial news, which are highlighted in <font> this article of top percentage movers </font> and trading volume leaders for Monday 6/8/09.  
 
Shares of Arena Pharma (NASDAQ:ARNA) climbed higher by about 25% on Monday after the Company said its obesity drug candidate lorcaserin helped patients lose and keep off weight in a clinical trial. Arena said patients who took lorcaserin had "highly significant" weight loss in their first year, and they were more likely to maintain the weight loss in their second year than those who took a placebo. The Company, which announced the results at the American Diabetes Association conference in New Orleans, said lorcaserin patients fared better in terms of cardiovascular risk, and the drug was not associated with heart valve problems or depression.
 
Meanwhile, Progenics Pharma (NASDAQ:PGNX) announced that its collaborator, Ono Pharmaceutical Co., Ltd. in Osaka, Japan, has begun clinical testing in Japan of Relistor (methylnaltrexone) subcutaneous injection, the first-in-class medicine approved in the U.S., Canada, the European Union, Australia and Latin American countries for the treatment of opioid-induced constipation. PGNX also announced the discontinuation of development for PRO 206, a pre-clinical compound for the treatment of hepatitis C virus (HCV) infection, in line with its ongoing initiative to allocate resources to the most important programs in order to increase operating efficiencies, and that it will instead focus on its second-generation HCV-entry inhibitor portfolio, anticipating selection of a new development candidate in 2010.
 
Disclosure: No positions.


March 15

Updated Clinical Trial and FDA Decision Calendars
Mikerun
   Mike Havrilla   03/15/09  

This pick is about: Acrux Ltd (ARUXF)
Rating:   Positive   $1.03 (03/15/09)
Closed:   07/03/2009 @ $0.0 ( n/a) in 110 days)
9 pts


Below is a summary of updates to the www.BioMedReports.com database of 242 entries included in the FDA and Clinical Trial Calendars. The two web links below are for the FDA calendar home page and a recent article highlighting 14 extreme trades of companies with market caps below $200M with pending FDA decisions.

http://biomedreports <wbr> </wbr> .com/fda-calendar.ht <wbr> </wbr> ml

http://biomedreports <wbr> </wbr> .com/articles/most-p <wbr> </wbr> opular/627-trading-f <wbr> </wbr> da-decisions-14-extr <wbr> </wbr> eme-trades.html

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 103 entries through today. The FDA Calendar includes the following information: company name, ticker, decision date, and description.

The Clinical Trial Calendar includes 139 entries as of today and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA , sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

1.) AspenBio Pharma ( APPY ): Plans to file a 510(k) with the FDA to seek clearance of the AppyScore ELISA product used in the pivotal trial as soon as the extensive filing application can be completed and reviewed by the Company's regulatory advisors. AspenBio expects that the product indication will be as an, "Aid in the Diagnosis of Appendicitis," to be used in conjunction with other physical and laboratory tests.

The clinical trial data analysis supports that the AppyScore analyte MRP8/14, provides valuable clinical information in the diagnosis of patients with lower right quadrant abdominal pain. AspenBio believes that the AppyScore test, upon commercialization,wi <wbr> </wbr> ll have a sensitivity and negative predictive value of greater than 90%. -- Data from the pivotal trial also demonstrated that when the AppyScore is interpreted in combination with other commonly used indicators, such as white blood count ( WBC ), the sensitivity and negative predictive value will be higher.

2.) Acrux (Australia: ACR.AX) (ARUXF.PK): Testosterone MD -Lotion development program achieves key milestone and will be commercialised as AXIRON -Enrollment of 150 men in pivotal Phase 3 open-label trial completed on schedule with trial results expected 3Q09 expected FDA submission during December 2009 - AXIRON targets a global market worth $900 million, growing at 20% per annum.

3.) Isolagen ( ILE ) submitted a BLA for Isolagen Therapy, which is a novel cell-based therapy for the treatment of wrinkles, with a standard review (10-month) PDUFA decision date of 1/9/10 . Isolagen Therapy would represent a new class of treatment in the facial aesthetic market as patients would receive their own cells to repair the skin if the FDA grants approval. Additionally, the company noted that it recently completed a Phase 2/3 trial for the treatment of acne scars with statistically significant efficacy results.

4.) Human Genome Sciences ( HGSI ): Expected global regulatory filings during Fall of 2009 for Albuferon (albumin-interferon alpha) in treatment of hepatitis C (HCV) types 2 or 3 viral infection - along with Novartis ( NVS ) - announced 3/9/09 met the main goal in a late-stage trial, but failed to show numerically better efficacy compared to standard-of-care, raising questions about the drug's adoption and sending shares crashing to an all-time low below 50 cents, with a rebound to a closing price of 71 cents on Friday.


June 12

FDA Calendar Updates: BDSI, SVNT Deadlines Approach
Mikerun
   Mike Havrilla   06/12/09  

This pick is about: Osteotech Inc. (OSTE)
Rating:   Positive   $4.11 (06/12/09)
Closed:   07/03/2009 @ $4.28 (+4.14% in 21 days)
9 pts


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.
 
Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.
 
 
Savient Pharma (NASDAQ:SVNT) announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA action date by three months to 8/1/09.
 
BioDelivery Sciences (NASDAQ:BDSI) has a pending Onsolis (BEMA fentanyl) NDA resubmission for the proposed treatment of breakthrough cancer pain through a small, dissolving polymer delivery system for the opiate painkiller fentanyl designed for quick absorption through the cheek. On 12/15/08, BDSI announced in a press release that the FDA requested conversion of the originally submitted risk minimization action plan (RiskMAP) to a Risk Evaluation and Mitigation Strategy (REMS) and informed the Company that all other aspects of the NDA review were complete.
 
Given this information, the prospects for Onsolis approval appear excellent, with an approval decision possible as early as Friday 6/12/09 or the following Monday based on a Class II (six-month) review by the agency on the resubmission of the required REMS by BDSI. In the same press release, BDSI provided guidance for expected approval of the Onsolis approval during the first half of 2009.
 
Earlier this year, BDSI raised $6M in cash from partner Meda AB (STO:MEDAA) ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company's current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.
 
While I do not typically hold small and micro-cap bio-med stocks through binary events such as FDA decisions and clinical trial results, BDSI is an exception for me and the Company expects to generate positive operating cash flow this year if Onsolis is approved. Also, the Company is debt free with a promising mid-stage pipeline based on its drug delivery technology platform that can be funded through milestone payments and royalties from Meda AB (which expects peak sales exceeding $200M for Onsolis).
 
Osteotech (NASDAQ:OSTE) : On 6/10/09, OSTE announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech's proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.
 
A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.
 
Human Genome Sciences (NASDAQ:HGSI) : On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.
 
HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGSI and GSK under a co-development and commercialization agreement entered into in August 2006.
 
Transcept Pharma (NASDAQ:TSPT) : On 6/11/09, TSPT announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09.
Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.
 
Disclosure: Long BDSI.


June 16

FDA Calendar Updates: BDSI is Worth the Wait, Zicam Warning
Mikerun
   Mike Havrilla   06/16/09  

This pick is about: ARYx Therapeutics Inc. (ARYX)
Rating:   Positive   $4.59 (06/16/09)
Closed:   07/03/2009 @ $4.52 (-1.53% in 17 days)
9 pts


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 6/16/09, shares of Matrixx Initiatives (NASDAQ:MTXX) were plunging after the FDA ordered the Company to stop selling zinc-containing, intranasal versions of its Zicam cold remedy after more than 130 reports of people losing their sense of smell. The FDA also urged consumers to stop taking the over-the-counter products, according to Agency officials on a conference call with reporters. MTXX must seek FDA approval if it wants to continue selling the zinc-containing versions of Zicam that are administered through the nose, agency officials said.
 
On 6/16/09, ARYx Therapeutics (NASDAQ:ARYX) announced that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of 7/6/09. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. The purpose of the trial is to evaluate whether tecarfarin is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation as measured by INR (International Normalized Ratio). Based upon recent interactions with the FDA, ARYX believes this trial could be positioned as one of the required registration studies for tecarfarin.
 
The trial of approximately 600 patients is a randomized, double blind, parallel group, active control study comparing tecarfarin with warfarin in patients who require chronic, oral anticoagulation. All patients in the study were treated for a minimum of six months and required anticoagulation therapy to avoid serious blood clotting resulting from their underlying condition. Tecarfarin (previously ATI-5923) is modeled on the drug warfarin as an oral blood thinner, which works in the same way (as a selective inhibitor of VKOR or the vitamin K epoxide reductase enzyme). Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYX believes this alternate metabolic pathway for tecarfarin may result in more predictable dosing and anti-coagulant response compared to warfarin.
 
On 6/16/09, GlaxoSmithKline (NYSE:GSK) and Genmab (CPH:GEN) (PINK:GNMSF) announced that the FDA informed the companies that the agency has extended the action date for the Arzerra (ofatumumab) BLA application by three months. The three month extension will allow the agency to review additional chemistry and manufacturing data submitted on 6/5/09. The BLA was submitted 1/30/09 and the FDA accepted the filing in April with priority review (six-month) status. On 5/29/09, the FDA Oncologic Drugs Advisory Committee (ODAC) voted 10-3 that the Arzerra data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. The new PDUFA action date for an expected FDA decision on the pending BLA is anticipated to occur during 4Q09.
 
On 6/15/09, BioDelivery Sciences (NASDAQ:BDSI) announced that the Company has reached agreement with the FDA on all aspects of its pending NDA for Onsolis (fentanyl buccal soluble film, BEMA fentanyl), including the lone outstanding requirement for a Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its PDUFA action date of 6/12/09, the FDA will not be issuing a review extension letter as their action on the NDA is forthcoming. BDSI received a Complete Response Letter (CRL) from FDA on the NDA for Onsolis on 8/28/08 with the only deficiency being the new requirement for a REMS. The REMS was not required at the time the NDA was originally submitted to FDA in October 2007.
 
The REMS was formally submitted to the FDA on 12/12/08 and the submission was placed under a six-month (Class 2) review period. BDSI provided the following guidance and commentary, "Although we cannot pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a first half 2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target. We view this as positive news, together with the fact that we have reached agreement with the reviewing division and the review team on all aspects of our NDA, including our REMS. Our dialog and working relationship with the reviewing division have been outstanding and have been fundamental to the progress we have made in working with them in this significant undertaking, to complete the first 'opioid' REMS and the first REMS for this Division.”
 
In conjunction with the update on the pending Onsolis NDA, BDSI stated that over the past several weeks the Company received funding associated with the exercise of outstanding warrants. With the additional funding, BDSI has adequate liquidity to fund normal operations and continue its clinical pipeline development through 4Q09. Earlier this year, BDSI raised $6 million in cash from partner Meda AB (STO:MEDAA) from a $3 million expanded marketing agreement and a $3 million advance of the milestone payment triggered by FDA approval and the U.S. launch of Onsolis.
 
 The remaining $26.9 million cash milestone payment is due upon FDA approval and the expected 4Q09 U.S. commercial launch of Onsolis, which represents over 20% of the Company's current market cap. In addition to double-digit royalties that BDSI will receive on the sale of Onsolis, the Company is eligible for an additional $30 million in sales-related milestone payments and a $5 million milestone payment that is due upon European approval (expected 1Q10) and launch.
 
While many momentum and biotech binary event traders may have exited BDSI recently with the stock price pulling back about 2 bucks from its high in the mid-$8 range; the final FDA approval for Onsolis could come at any time. Recent FDA approvals for Entereg, Cimzia, and Nplate provide examples of missed PDUFA action dates for drugs which also required REMS. In these cases, final FDA decisions occurred in a range of 10-30 days after the original PDUFA date, which translates into a possible Onsolis approval announcement sometime during late June to mid-July.
 
During the 6/15/09 conference call, BDSI clearly stated that Onsolis would already be on the market if not for the REMS requirement. Now that BDSI has reached agreement with the review team on the REMS; the Company is simply waiting for the FDA to issue its final decision on the NDA. In addition, the Onsolis NDA represents the first REMS submitted to the FDA associated with an opiate drug compound; so a minor delay in the final approval is not surprising.
 
If you think BDSI will trade above its current level in the mid-$6 range upon FDA approval of Onsolis; the recent pullback provides an excellent entry point given the near certainty of attaining FDA approval based on the Company’s dialogue with the Agency outlined above and in the conference call earlier this week.
 
Disclosure: Long BDSI.


May 11

FDA Calendar Updates: Royal Returns for King Pharma
Mikerun
   Mike Havrilla   05/11/09  

This pick is about: King Pharmaceuticals Inc. (KG)
Rating:   Positive   $9.22 (05/11/09)
Closed:   07/02/2009 @ $9.63 (+4.45% in 52 days)
9 pts


 
Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
 
Shares of King Pharma (NYSE:KG) have gained about 35% since <font> I wrote about the Company </font> in late March as a value play on pending new drug approvals. Below are updates on three new pain drug candidates from King's quarterly results and business update today.  
 
Embeda (morphine + naltrexone) has a pending NDA for proposed use as a pain drug that is designed to deter abuse and diversion. During 1Q09, KG received feedback from the FDA regarding a Risk Evaluation and Mitigation Strategy (REMS) for Embeda and is in discussions with the agency. KG remains confident that Embeda will be approved in the near future.
 
The Acurox (oxycodone + niacin) NDA has a priority review (six-month) designation by the FDA along with Acura Pharma (NASDAQ:ACUR) with a PDUFA decision date of 6/30/09. Acurox is an immediate release opioid analgesic with a proposed indication for the relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse.
 
During 1Q09, KG assumed full control from Pain Therapeutics (NASDAQ:PTIE) of all activities related to the development of Remoxy, which is a long-acting oxycodone formulation designed to deter abuse and misuse. KG has set a new date with the FDA in the first half of July 2009 to discuss the Complete Response Letter (CRL) issued by the agency in December 2008 to clarify the non-clinical information required to gain approval for Remoxy.
 
Disclosure: No positions.


January 05

A New Index of Health Product Innovators
Mikerun
   Mike Havrilla   01/05/09  

This pick is about: Eisai Co Ltd (ESALY)
Rating:   Positive   $39.55 (01/05/09)
Closed:   07/02/2009 @ $0.0 ( n/a) in 178 days)
9 pts


A New Index of Health Product Innovators



The accompanying table includes statistics and all 23 companies in the ETF Innovators [ETFI] Global Health Innovators Index of companies with market caps over $250M which received FDA approval in the past 12 months for an original new drug product or medical device.

The index includes companies which get approvals for drugs or biological agents classified as new chemical entities (i.e. excluding all new formulations of existing drugs, generic drugs, and label extensions for existing products). Also, companies which receive original PMA approvals for new medical devices are included in the index, excluding the less rigorous and more numerous 510(k) applications.

The goal of the index is to track the performance of companies which are developing innovative new drugs and medical devices to see whether their investment in R&D pays off in the form of better stock price performance compared to benchmark ETFs for pharma, biotech, medical devices, and the overall healthcare sector.

The Health Innovators Index fared better than the overall market and all five benchmark ETFs over the past year while posting a loss of 3.3% on an equal-weight basis, compared to losses of 20.9% for the Healthcare SPDR (XLV), 10.6% for the iShares Nasdaq Biotech (IBB), 18% for the Pharma HOLDRs (PPH), 8.5% for the PowerShares Dynamic Pharma (PJP), 36.8% for the iShares Medical Devices (IHI), and 34.3% for the S&P 500 SPDR (SPY).

Stocks in the index which managed to post gains over the past year despite unprecedented market turmoil include Thoratec (THOR) (+79.3%), ViroPharma (VPHM) (+66.6%), Amgen (AMGN) (+31.7%), Eisai (ESALY) (+10.9%) (acquired MGI Pharma), Cephalon (CEPH) (+8.7%), CV Therapeutics (CVTX) (+3.7%), and Watson Pharma (WPI) (+0.8%).


June 07

Seven Extreme FDA Medical Device Trades
Mikerun
   Mike Havrilla   06/07/09  

This pick is about: Nephros Inc. (NEPH)
Rating:   Positive   $0.0 (06/07/09)
Closed:   07/02/2009 @ $0.0 ( n/a) in 25 days)
1 pt


Below is a sample of <font> extreme FDA trades </font> on pending medical device decisions (510k or PMA filings) among companies with market caps below $200 million which are taken from the <font> BioMedReports.com FDA Calendar </font> database. The FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. The review period for PMA filings is typically more involved and longer than 510(k) applications.
 
 
Nephros (OTC: NEPH) has surged by over five-fold in just two weeks from 14 cents to 82 cents from the time of my initial article on extreme FDA trades on pending medical device decisions. NEPH.OB still has three separate FDA 510(k) applications pending at the agency, which are outlined below.
 
The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for End-Stage Renal Disease (ESRD) patients while addressing the critical financial and clinical needs of the care provider. The HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, according to the Company. On 11/14/08, Nephros submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA has requested additional information. Nephros replied to the FDA inquiries on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company for an estimated decision date of Friday 6/12/09 or Monday 6/15/09.
 
On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA requested additional information, and Nephros provided a formal response to the agency on 2/24/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided (5/26/09), but a response from the agency is still pending.
 
Bovie Medical (AMEX: BVX) currently has two pending medical device applications at the FDA, and the Company is working toward two additional 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology. While the two pending medical device applications outlined below do not have firm decision dates, my estimate for a possible FDA decision is currently some time during 3Q-4Q09 based on the review cycle for the Company’s previous medical device filings.
 
On 3/3/09, BVX announced the filing of a 510(k) pre-market notification application (PMA) for regulatory clearance of its ICON GS electrosurgical generator and handpiece (J-Plasma system). The technology utilizes a gas ionization process producing a stable thin focused beam of ionized gas that can be controlled in a wide range of temperatures and intensities for greater surgical precision which is minimally invasive.
 
On 5/19/09, BVX announced a 510(k) submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection. The laparoscopic SEER is a line extension of the Saline Enhance Electrosurgical Resection (SEER) device that Bovie launched earlier this year and will address the growing market of minimally invasive liver resection. The laparoscopic SEER allows the surgeon to dissect and achieve hemostasis with a single device resulting in less instrument utilization and fewer instrument changes in a minimally invasive approach.
 
Nanosphere (NASDAQ: NSPH) has three 510(k) applications pending at the FDA with estimated decisions during 2H09, including diagnostic assays for cystic fibrosis and hemochromatosis (a disorder in which excessive amounts of iron are absorbed and accumulate in the body in tissues and organs such as the heart and liver), along with a second generation version of its Verigene System that incorporates automated sample processing.
 
In March 2009, BioForm Medical (NASDAQ: BFRM) announced the results of a clinical trial evaluating the mixing of lidocaine with RADIESSE dermal filler, which demonstrated an approximate 60% reduction of pain when RADIESSE dermal filler was mixed with lidocaine, and comparable safety and effectiveness of mixed and non-mixed RADIESSE dermal filler. The results were submitted to the FDA under a PMA supplement with an estimated decision during 3Q-4Q09 since the FDA does not issue decision date deadlines for medical device filings.
 
On 5/26/09, iCAD Inc. (NASDAQ: ICAD) announced that it submitted data to the FDA seeking 510(k) marketing clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or “virtual” colonoscopy. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist. VeraLook has the potential to reduce oversight errors that could occur during review of a virtual colonoscopy exam, due to the large number of images (approximately 1500) generated by the CT system.
 
On 6/4/09, Electro-Optical Sciences (NASDAQ: MELA) announced the submission to the FDA of its Premarket Approval (PMA) application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and May. The Company's final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians.
 
During 1Q09, Cardium (AMEX: CXM) submitted an application for FDA 510(k) clearance of the UroCool pelvic cooling catheter system. Cardium intends to advance InnerCool's therapeutic cooling and warming products into corresponding markets through the strategic sale of the business to a large and diversified medical device company or through various vertical partnering opportunities with established companies having existing sales and marketing organizations but with a continuing need for innovative, high-value content products.
 
Disclosure: No positions.


April 23

FDA, Clinical Trial Calendar Updates: Acorda, Alkermes, GTx
Mikerun
   Mike Havrilla   04/23/09  

This pick is about: Acorda Therapeutics Inc. (ACOR)
Rating:   Positive   $22.0 (04/23/09)
Closed:   07/01/2009 @ $24.6 (+11.82% in 69 days)
9 pts


Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars .
 
The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
 
1.) Akermes (ALKS): Earlier this week, ALKS announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.
 
2.) Acorda Therapeutics (ACOR): On 4/23/09, ACOR announced the resubmission of its NDA for Fampridine-SR to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS). Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA in late March, citing the need to correct “format issues” and requesting additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, Acorda has resubmitted the Fampridine-SR NDA and believes that all of the Agency’s comments related to the RTF have been addressed. 6/23/09 is the date for FDA to accept this filing and 2/23/10 would be the PDUFA decision date for a standard, 10-month review of the NDA if accepted.
 
3.) GTx Inc. (GTXI): On 4/22/09, GTXI announced that data from its Phase 3 clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy will be the subject of an oral podium presentation at the 2009 Annual Meeting of the American Urological Association being held in Chicago April 25-30.
 
GTXI is awaiting a FDA decision for its toremifene 80 mg NDA (standard 10-month review) for bone loss due to prostate cancer. Toremifene 80 mg is an oral selective estrogen receptor modulator which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT). ADT is primary treatment for advanced prostate cancer. In the United States, approximately 700,000 men with prostate cancer are being treated with ADT and an estimated 100,000 initiate ADT each year.
 
Disclosure: No positions.


June 29

FDA Calendar Updates: AMAG, PPDI, Takeda
Mikerun
   Mike Havrilla   06/29/09  

This pick is about: Advanced Magnetics Inc. (AMAG)
Rating:   Positive   $54.76 (06/29/09)
Closed:   06/30/2009 @ $54.67 (-0.16% in 22 hours)
9 pts


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 6/29/09, AMAG Pharma (NASDAQ:AMAG) announced that it has not received an action letter from the FDA for Feraheme (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. The PDUFA action date was 6/29/09, and the FDA informed AMAG that the Agency would not take action today but expects to issue an action letter within the next few days. The FDA has not requested any additional information from AMAG, and it is the Company’s understanding that there are no outstanding issues regarding the Feraheme NDA.
 
On 4/30/09, AMAG reported that the FDA was satisfied with observations noted during a recent inspection of the Company's manufacturing facility. AMAG also noted that a re-inspection of its manufacturing facility would not be required as a pre-requisite to FDA approval of Feraheme. AMAG has previously issued guidance on labeling discussions, which are likely to include a broad label that includes both dialysis and non-dialysis patients with CKD. On 5/12/09, AMAG announced the FDA accepted the Company’s resubmission of its Feraheme (ferumoxytol injection) NDA in response to a December 2008 Complete Response Letter as a complete Class 1 (60-day review) response.
 
On 6/26/09, Takeda Pharma (TYO:4502) (PINK:TKPHY) received a complete response letter (CRL) from the FDA for the Company's New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting a new clinical trial to assess the cardiovascular safety profile of alogliptin.
 
As previously announced on 3/6/09, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance evaluating cardiovascular risk in new diabetes drugs, the Agency did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in the new guidance. Pharmaceutical Product Development (NASDAQ:PPDI) is set to receive $25 million as a milestone payment at the time of alogliptin FDA approval.
 
Disclosure: Long AMAG.


June 25

FDA Calendar Updates at BioMedReports.com
Mikerun
   Mike Havrilla   06/25/09  

This pick is about: AstraZeneca PLC (AZN)
Rating:   Positive   $45.01 (06/25/09)
Closed:   06/30/2009 @ $44.0 (-2.24% in 5 days)
9 pts


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 6/25/09, H. Lundbeck (CPH:LUN) (PINK:HLUKY) announced that the Company has received a Complete Response Letter (CRL) from the FDA for Serdolect (sertindole) for the treatment of schizophrenia. The Agency's CRL includes a request for additional data to best understand the appropriate patient population for which Serdolect could be made available, and the Company is currently evaluating the information in order to resolve the outstanding questions and discuss the next steps required to bring Serdolect safely to the U.S. market.
 
 In the coming months, the Company expects to address the CRL and will work with the FDA to expedite completion of its review. On 4/7/09, a FDA Advisory Panel voted 8-2 (three panelists abstained from the vote) in favor of FDA approval for Serdolect among certain patients (such as those who do not respond to other treatments) despite concerns about heart-related risks. The Company proposed that Serdolect reduced suicide attempts, which is a major risk for patients with schizophrenia. However, the panel rejected this notion in a 12-1 vote based on a lack of convincing evidence to support the claim. Serdolect received marketing approval for the treatment of schizophrenia from the European Commission on 12/20/05 and is available in 40 countries worldwide.
 
European regulators have recommended approval of Onglyza (saxagliptin) a new diabetes drug from AstraZeneca (NYSE: AZN) and Bristol-Myers (NYSE: BMY), which clears the way for its launch in the coming months as such recommendations are typically endorsed by the European Commission within two or three months. The two companies announced that their drug won a positive opinion for type 2 diabetes as an as add-on therapy along with older medications such as metformin, thiazolidinedione or sulphonylurea. On 4/1/09, the Endocrinologic and Metabolic Drugs Advisory Committee for the FDA voted 10 to 2 that the companies' data ruled out the risk that the drug hastens heart attack, stroke and other problems with a final decision by the Agency expected by late July.

On 6/25/09, Insmed (NASDAQ:INSM) announced results from a Phase II clinical trial evaluating IPLEX (mecasermin rinfabate) in patients with myotonic muscular dystrophy (MMD). The randomized, double-blind, placebo-controlled Phase II trial conducted in 13 centers across the U.S. enrolled 69 patients with MMD, for a six-month period. The results of the trial indicated that IPLEX did not exhibit a statistically significant improvement in the functional measure of endurance by the six-minute walk test, muscle function, muscle strength, or quality of life in any of the tests utilized in this study. Based on the limited number of subjects enrolled with significant impairments in cognitive function, gastrointestinal function or pain, INSM was unable to reach any conclusions regarding the effects of IPLEX on these endpoints.
 
IPLEX did, however, demonstrate improvements in standard measures of insulin sensitivity and reductions in fasting glucose, fasting insulin, cholesterol and triglycerides, which is consistent with the expected metabolic profile of insulin-like growth factor. Administration of IPLEX also resulted in anabolic effects of increased body mass index and higher levels of testosterone. Based on the metabolic improvements observed in patients treated with IPLEX in this trial, and discussions with key opinion leaders, the Company intends to apply for a grant from the Muscular Dystrophy Association ("MDA") to facilitate an additional Phase II trial focused solely on a subset of MMD patients with severe insulin resistance who, based on the results of this trial, may be more likely to benefit from IPLEX treatment.
 
On 6/25/09, OraSure Technologies (NASDAQ:OSUR) provided the following updates for two diagnostic tests in development for hepatitis C virus (HCV) and an over-the-counter (OTC) diagnostic test for the detection of HIV.
 
During 4Q08, OSUR filed a premarket approval application (PMA) with the FDA for approval of an OraQuick HCV test for use in the professional market. The application sought approval for use of the product with multiple specimen types, including venous whole blood, fingerstick whole blood, oral fluid and other sample types. During its review of the PMA, the FDA indicated that the Company’s clinical data could potentially have been affected by bias because the same operators performed the test and interpreted the results on multiple specimen types derived from the same patient. The FDA recently concluded that additional clinical testing will be required to obtain approval of the PMA for a venous whole blood claim, and that a new clinical study will be required for approval of claims for oral fluid and other sample types.
 
Although the Company believes the clinical data originally submitted to the FDA is sufficient to support approval of its PMA, the Company has agreed to conduct the additional clinical testing and study mandated by the FDA in order to obtain approved claims for oral fluid, venous whole blood, and fingerstick whole blood. The exact timing and costs associated with this work will not be fully determined until after protocols are submitted and reviewed by the FDA, which should occur in the next several weeks. The Company expects first to complete the additional testing required for a venous whole blood claim and submit that data to the FDA for review and approval, while the additional study for the other specimen types is completed. The Company also plans to submit its application for CE mark for the OraQuick HCV test shortly, which is required to sell the test in Europe.
 
In August 2008, OSUR submitted the results of its observed use study to the FDA as part of its efforts to obtain approval for an OraQuick rapid HIV OTC diagnostic test. The observed use study was designed to assess an individual’s ability to interact with the product packaging, comprehend the instructions for use, take the test and interpret the results while a trained professional observed those activities. The observed use study was stopped after testing was completed for the first 1,000 subjects, because data from the study met the success criteria initially established in the study protocol for this phase of the trials.
 
The FDA recently reviewed the data from the observed use study at a meeting of its senior management. Following this meeting, the FDA contacted the Company and indicated that both the results of the observed use study and the Company’s remaining clinical activities should also be reviewed and approved by the Blood Products Advisory Committee (“BPAC”), an advisory committee to the FDA, before proceeding. The Company will meet with the FDA to discuss plans for the upcoming BPAC meeting. The Company intends to gain alignment with the FDA on the next steps required to complete and file a PMA application, before presenting a proposal at the BPAC’s meeting scheduled for November 2009.
 
During late afternoon trading on 6/25/09, shares of Caraco Pharma (AMEX:CPD) plunged by about 50% on newswire reports that U.S. authorities seized generic medicines made by the Company at facilities in Michigan following repeated violations of manufacturing standards. The seized drugs included generic versions of heart, pain and psychiatric medicines, according to FDA officials. In late May, Caraco provided the following update on the status of a FDA inspection of the Company's Detroit manufacturing facilities stemming from an October 2008 warning letter. The following information was <font> posted at the FDA website </font> as part of a late afternoon news release:
 
U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco at the Company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”
 
Disclosure: No positions.


May 25

FDA Calendar Update: Acusphere (OTC:ACUS), Cephalon (NASDAQ:CEPH)
Mikerun
   Mike Havrilla   05/25/09  

This pick is about: Cephalon Inc (CEPH)
Rating:   Positive   $58.34 (05/25/09)
Closed:   06/30/2009 @ $56.57 (-3.03% in 36 days)
9 pts


Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  
 
Below is a summary of press releases from Acusphere, Inc. (OTC:ACUS) from this year, which are available in full directly from the Company's website at <font> www.Acusphere.com </font> . Based on the most recent press release last week, ACUS expects to have sufficient liquidity to fund operations until the end of 3Q09 due to cost-cutting initiatives.
 
However, the most recent press release states that discussions with the FDA continue regarding the design of a clinical program to address the FDA's complete response letter (CRL) for Imagify and makes no mention of the amended NDA with a narrower claim referenced in earlier press releases. While previous press releases in February and March mentioned FDA meetings to "discuss alternatives" , an "amended NDA" , and a "narrower claim" for Imagify; the Company's latest press release from 5/19/09 only mentions that discussions continue with the FDA regarding the design of a clinical program to satisfy the issues raised in the CRL by the FDA for Imagify.
 
Since ACUS no longer mentions the amended NDA for Imagify as part of its discussions with the FDA; there is no definitive timeline for a FDA decision on the NDA until further notice from the Company on the strategy and timeline to satisfy the issues raised by the FDA in the CRL for Imagify. BioMedReports.com contacted the Company in an attempt to receive more clarity on the strategy and timeline for Imagify in early May, but has not received a response as of yet.
 
The other major variable with ACUS beyond the Imagify story at the FDA the role of Cephalon (NASDAQ:CEPH) as the Founder, Chairman, and CEO of CEPH, Dr. Frank Baldino, also serves on the <font> Board of Directors for ACUS </font> . <font> Cephalon's 4Q08 conference call transcript </font> includes the following excerpts related to ACUS:
 
"We excluded $17 million associated with the acquisition of Licensed Technology from Acusphere. . . In November 2008, Acusphere became a variable interest entity to which we are the primary beneficiary. As a result we are consolidating that company’s results. Operating expense guidance increased compared to our previous guidance predominantly as a result of VIE accounting for Acusphere inception. Consequently, we will eliminate approximately $50 million of expense as non-control and minority interest."
 
19-May-2009 : The Company continues to discuss its New Drug Application (NDA) with the FDA for its lead product candidate, Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension, a Perfusion Stress Echo imaging agent targeted for use in detecting coronary artery disease. The Company previously announced that it had received a complete response from the FDA for Imagify in February 2009, FDA's target date under PDUFA guidelines. The response was largely consistent with the feedback received at the Advisory Committee meeting in December 2008, and discussions that continued with FDA in January 2009. In general, FDA's response stated that additional clinical work would be required to support approval. Discussions with FDA continue regarding the design of the clinical program.
 
31-March-2009 : The Company previously announced that it had received a complete response from the FDA for Imagify. The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. The Company was also invited by FDA to schedule a meeting to discuss alternatives for moving forward.
 
11-March-2009 : ACUS announced today that it has received a complete response from the FDA. The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. As previously announced, The Company also submitted in February 2009 a narrower claim with a potentially improved risk-to-benefit ratio. The Company was also invited by FDA to schedule a meeting to discuss alternatives. The Company is in the process of scheduling the meeting.
 
17-Feb-2009 : ACUS announced today that it has submitted an amendment to its NDA for Imagify. The NDA was submitted to the FDA in April 2008 and filed in June 2008. If FDA accepts the submitted amendment, the Imagify indication will be limited to subsets of patients undergoing pharmacologic stress techniques. The amended indication is focused on patients where the risk-to-benefit ratio of Imagify is more compelling than the broader indication that was originally filed. Since this is a significant amendment to the NDA for Imagify, it is likely that the FDA will push back the PDUFA target date for their complete response letter from February 28, 2009 to May 31, 2009.
 
I have removed ACUS from the FDA Calendar of pending decisions after their most recent press release last week until the Company provides more clarity on the strategy and timeline for the Imagify NDA. However, with a market cap of just $15M, cost-cutting initiatives to fund operations until the end of 3Q09, and the CEPH involvement; ACUS is still an attractive stock for the most aggressive and speculative investors and traders in the bio-med space due to the inherent value in its core microsphere drug delivery technology platform rather than an imminent FDA decision for Imagify.
 
Disclosure: No positions.


May 06

Access Pharma (OTC:ACCP): Low Valuation, Big Potential
Mikerun
   Mike Havrilla   05/06/09  

This pick is about: SanofiAventis (SNY)
Rating:   Positive   $29.29 (05/06/09)
Closed:   06/30/2009 @ $29.36 (+0.24% in 55 days)
9 pts


With shares of Cell Therapeutics (NASDAQ:CTIC) staging the most astonishing comeback I have ever witnessed while rising from 8 cents at the time of <font> my original article in early February </font> to as high as $1.85 during intraday trading today and closing at $1.27 – I went in search of another out-of-favor name in the cancer biotech space.
 
Access Pharma (OTC:ACCP) is an emerging bio-pharma company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to an FDA approved treatment for a side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). Valued at roughly $30M, ACCP has multiple shots at goal in its clinical pipeline in addition to a reduced risk profile because the compounds in development are improved versions of existing drugs with established mechanisms of action.
 
The Company has completed six partnerships within the past 18 months with more expected to follow as ACCP seeks to mitigate the inherent risk of the clinical development process. ACCP has assembled a diverse and experienced team of executives and consultants while insiders own a significant (50%) stake to ensure their interests are aligned with shareholders.
 
MuGard is the Company's FDA-approved product which functions like a liquid Band-Aid to protect the lining of the oral cavity in cancer patients who develop mucositis as a side effect of radiation or chemotherapy. By 3Q09, the product will be launched in all major global markets with estimated peak sales of $350M (based on marketing partner estimates) and a scaled royalty rate of 20-25% (i.e. over $70M royalties on peak sales which is over 2X the current market cap).
 
A very promising, next-generation platinum anti-cancer compound in the Company's pipeline is known as ProLindac, which includes a proprietary nano-polymer delivery vehicle that allows for over 10X the dose of platinum to be delivered to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the platinum in a targeted manner to cancer cells, which reside at a low pH (acidic).
 
ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5B in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. ACCP also employs Esteban Cvitkovic as their director of oncology R&D – who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin.
 
Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending. Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy.
 
Thiarabine is the Company's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Once again, ACCP is working with the leader in this field – in this case, Dr. Hagop Kantarjian, who is Head of the Leukemia Department at the M.D. Anderson Cancer Center in Houston (which is the primary treatment centre in the U.S. for leukaemia and lymphoma). The Company is currently finalizing clinical trial protocols based on previously gathered data to evaluate the drug in a variety of leukaemia and lymphoma subtypes.
 
ACCP also has a monoclonal antibody (MAb) with encouraging preclinical results in comparison to Roche's (VTX:ROG) (OTC:RHHBY) Avastin. Angiolix targets a specific portion of a protein called lactadherin that is only expressed on solid tumors. Angiolix has a dual mechanism of action, which includes (1) inhibiting angiogenesis (blood vessel proliferation which feeds tumor growth) via the lactadherin target and (2) inducing a process known as apoptosis or programmed cell death in cancer cells which are dividing and growing in an unregulated manner. Unlike Avastin, Angiolix has an anti-proliferative effect on cancer cells when used by itself in addition to when it is used in combination with other chemo drugs.
 
The Company also offers a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This novel delivery mechanism utilizes the body's vitamin B12 absorption system in a Trojan Horse manner with the potential to eliminate the need for injections.
 
The 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 and its contents of large molecule drugs not normally available by oral administration (e.g. insulin, hGH, EPO). This process increases the cellular uptake in the gut of such large molecule drugs by a factor of 1,000X to 1,000,000X.
 
ACCP anticipates an expense of $2M and about 12-15 months to get an IND filed to initiate clinical trials in humans; although this timeline could be shortened if such trials were conducted outside of the U.S. A long-acting, basal insulin product (similar to Lantus) is the most advanced in terms of achieving oral bioavailability of 80-90% after initially achieving results in the 30-40% range. hGH, which is about 3X larger than insulin on a molecular basis, is currently in the 30-40% bioavailability range in preclinical animal models.
 
The Company has about 22M total shares of common stock, including 11.3M shares outstanding and 10.6M shares of common stock under preferred shares – please note the financial data providers such as Yahoo and Google Finance only include the 11.3M shares in their calculations of market cap and other metrics. ACCP has a $5.5M note due at the end of 2011, which is convertible at a price of $27.50 per share.
 
ACCP projects that it will have sufficient liquidity into 2010 based on its current cash/equivalents ($2.7M at year-end) and expected upfront, royalty, and milestone payments. During 2H09, the Company plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail, Pexiganan).
 
The final Phase 2 ovarian cancer trial results are also pending and ACCP is engaged in ongoing discussions for either regional or a global partnership deal for the drug in addition to initiating Phase 2 studies of the drug in combination with other chemo drugs (paclitaxel, gemcitabine). ACCP is seeking to transition from OTC to re-list on a national exchange such as Nasdaq in order to increase its visibility and liquidity for investors.
 
Given a very low cash burn rate of about $4M per year, a diverse/late-stage pipeline, extensive partnership agreement, and the pending global commercialization of MuGard by 3Q09 with a 20-25% royalty rate, the current market valuation of around $30M does not appear to fully account for both the breadth and depth of the pipeline in addition to the large commercial markets the compounds are designed to serve. If MuGard reaches just $20M in global sales at a 20% royalty rate, this alone would cover the current low rate of cash burn itself.
 
Please visit the <font> research section of BioMedReports.com </font> to view or download the PDF stock research reports for ACCP written by Griffin Securities.
 
Disclosure: No positions.


March 09

Upcoming FDA Advisory Panel Meetings
Mikerun
   Mike Havrilla   03/09/09  

This pick is about: Takeda Pharmaceutical Co Ltd ADR (TKPHY)
Rating:   Negative   $15.1 (03/09/09)
Closed:   06/29/2009 @ $0.0 ( n/a) in 112 days)
9 pts


A trio of diabetes drug candidates are affected by a tougher stance at the FDA for this class of drugs, which is focused on cardiovascular risks such as heart attack and stroke. Two of the drugs will be reviewed at early April FDA advisory panel meeting while a third will likely require additional clinical trials.

http://www.biomedreports.com/fda-calendar.html

In December the FDA issued a new guidance document that recommended more stringent clinical trials for diabetes drugs to better assess heart attack and stroke risks. In a change that was effective immediately, the agency said studies should "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies."

The agency is calling for extended diabetes clinical studies to include older and sicker patients at higher risk of having a heart attack or stroke and a longer follow-up period lasting up as long as two years (versus 3-6 months).

1.) Novo Nordisk (NVO): Victoza (liraglutide) NDA for Type 2 Diabetes - April 2-3 FDA Advisory Panel Meeting - (Original PDUFA date was 3/23/09). Victoza (liraglutide) is used once-daily via subcutaneous injection. Liraglutide is a synthetic glucagon-like peptide-1 (GLP-1) and is classified as an incretin mimetic type of diabetes drug.

GLP-1 is a gut-derived regulator of glucose that is released after oral ingestion of carbohydrates or gats. Type 2 diabetics have reduced levels of GLP-1 in response to carbohydrate intake. GLP-1 enhances insulin secretion once it enters the systemic circulation and also increases the synthesis of insulin.

Other effects of GLP-1 include suppression of glucagon secretion, slower gastric emptying (5-10% incidence of nausea), reduced food/caloric intake, and pancreatic beta cell proliferation. Liraglutide does not increase insulin secretion or suppress glucagon secretion when blood glucose levels are low or normal.

2.) Bristol-Myers (BMY) and AstraZeneca (AZN): Onglyza (saxagliptin oral tablets) NDA - A dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes -- 4/1/09 FDA Advisory Panel Meeting -- Endocrinologic and Metabolic Drugs Advisory Committee. DPP-4 inhibitors work by increasing the level of incretin hormones in the body which help lower blood glucose levels, with the only marketed product in the class represented by Merck's (MRK) Januvia.

3.) Takeda Pharma (TKPHY.PK): Shares of the largest Asian drug company fell the most in 21 years on concern U.S. approval of its diabetes drug alogliptin, a successor to its top selling diabetes drug Actos will likely be delayed and require additional clinical studies. Although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.

Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin's Prescription Drug User Fee Act (PDUFA) date - June 26, 2009 - remains unchanged. In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes".

4.) Genentech (DNA): Avastin (bevacizumab) sBLA - brain cancer (relapsed glioblastoma) -3/31/09 Advisory Panel Meeting -FDA Oncologic Drug Advisory Committee - 5/5/09 is PDUFA decision date deadline.



June 16

BioMedReports FDA Calendar: Hot Summer Trades
Mikerun
   Mike Havrilla   06/16/09  

This pick is about: Advanced Magnetics Inc. (AMAG)
Rating:   Positive   $50.47 (06/16/09)
Closed:   06/29/2009 @ $54.76 (+8.50% in 13 days)
9 pts


Below is a sample of entries from the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some <font> Extreme Trades </font> of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact.
 
 
Rigel Pharma (NASDAQ:RIGL): On 5/5/09, RIGL reported its quarterly financial results and stated that the Company expects to deliver top-line results in July 2009 from its TASKi2 and TASKi3 Phase 2b clinical trials, which add over 670 additional patients studied with lead compound R788 (given by oral administration) in rheumatoid arthritis (many of the treatments for this condition are given by injection which is not a popular route of administration) to the 189 patients studied from the Company’s Phase 2a trial results reported in December 2007 (check out a two-year stock price chart to see the major upside impact of these results).
 
On 6/1/09, RIGL announced that its oral Syk inhibitor, R788, is also being evaluated in a Phase 2 clinical trial funded, designed and implemented by the National Cancer Institute (NCI), part of the U.S. National Institutes of Health. This open-label, single arm clinical trial will include patients with advanced colorectal, thyroid, non-small cell lung, hepatocellular, head and neck, or renal cell cancers who have failed to respond to at least one line of therapy. In addition, the company has an ongoing Phase 2 clinical trial of R788 in patients with peripheral T-cell lymphoma and reported favorable results from a Phase 2 clinical trial of R788 in the treatment of patients with certain B-cell lymphomas in June 2008.
 
Aeterna Zentaris (NASDAQ:AEZS): On 6/15/09, AEZS reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033).
 
Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010. AEZS has also announced recently that patients completing two years of therapy with cetrorelix in the first efficacy study (study 033), will be eligible to continue with the cetrorelix treatment, according to treatment regimen of the ongoing Phase 3 study, until the end of 2011. Patients entering this extension study sponsored by the Company's partner Sanofi-Aventis (NYSE:SNY), will be followed-up for safety, International Prostate Symptom Score (IPSS) and quality of life during the extended treatment, providing follow-up data on cetrorelix for up to 5 years.
 
Insmed (NASDAQ:INSM): On 5/13/09, INSM reported its quarterly operating results, including an update on the clinical development of IPLEX, for which the Company continues to expect preliminary Phase 2 results in the treatment of Myotonic Muscular Dystrophy (MMD) during 2Q09. The FDA will also allow Insmed to provide access to IPLEX for investigational use in patients with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease), and the Company will conduct a controlled clinical trial under an Investigational New Drug (IND) application after finalizing the study protocol with the FDA.
 
Jazz Pharma (NASDAQ:JAZZ): On 6/15/09, JAZZ announced that sodium oxybate (JZP-6) demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase 3 data presented last week. JAZZ has also completed its second Phase 3 clinical trial of JZP-6 and expects to announce top-line results from this study around mid-2009. Assuming positive results for the second study, the company anticipates submitting a NDA for sodium oxybate for the treatment of fibromyalgia to the FDA by the end of 2009. UCB SA (EBR:UCB) (PINK:UCBJF) anticipates filing in the EU shortly after. UCBJF.PK has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North America and will manage registrations accordingly.
 
Human Genome Sciences (NASDAQ:HGSI): On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.
 
HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGSI and GSK under a co-development and commercialization agreement entered into in August 2006.
 
Takeda Pharma (TYO:4502) (PINK:TKPHY): Pending alogliptin (SYR-322) NDA for the proposed treatment of Type 2 Diabetes. Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of Type 2 diabetes. Pharmaceutical Product Development (NASDAQ:PPDI) receives $25 million if alogliptin receives FDA approval. Although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA announced that it will apply these guidelines when reviewing the alogliptin NDA. Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional cardiovascular (CV) studies with alogliptin.
 
Alogliptin's PDUFA action date remains unchanged at 6/26/09. In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date of 10/27/08 due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.
 
AMAG Pharma (NASDAQ:AMAG): On 4/30/09, AMAG reported that the FDA was satisfied with observations noted during a recent inspection of the Company's manufacturing facility. AMAG is awaiting a decision by the agency for its iron replacement therapy, Feraheme (ferumoxytol injection), to treat iron deficiency anemia in patients with chronic kidney disease (CKD). AMAG also noted that a re-inspection of its manufacturing facility will not be required as a pre-requisite to FDA approval of Feraheme. AMAG has previously issued guidance on labeling discussions, which are likely to include a broad label that includes both dialysis and non-dialysis patients with CKD. On 5/12/09, AMAG announced the FDA accepted the Company’s resubmission of its Feraheme™ (ferumoxytol injection) New Drug Application in response to the December 2008 Complete Response letter as a complete, Class 1 response with a PDUFA date of 6/29/09.
 
King Pharma (NYSE:KG) and Acura Pharma (NASDAQ:ACUR): Acurox (oxycodone + niacin) NDA (priority review). Acurox is an immediate release opioid analgesic, has a proposed indication for relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse. The expected PDUFA action date for a FDA decision is 6/30/09.
 
Spectrum Pharma (NASDAQ:SPPI): Zevalin (Ibritumomab Tiuxetan) (a radio-immunotherapeutic that specifically targets and kills cancer cells) sBLA to expand FDA-approved label as a first-line consolidation therapy (following a response to first-line treatments) for non-Hodgkin's lymphoma (NHL). On 2/23/09, a three-month PDUFA action date delay to 7/2/09 was announced as SPPI submitted additional data to the FDA, which was classified as a major amendment by the agency.
 
Labopharm (NASDAQ:DDSS): DDSS has a pending NDA for a rapid-onset formulation of trazodone (DDS-04A) filed through the 505(b)(2) pathway as a new formulation of an existing drug for the proposed treatment of major depressive disorder with an estimated PDUFA action date of 7/18/09 for a possible FDA decision.
 
United Therapeutics (NASDAQ:UTHR): UTHR announced on 4/28/09 that the FDA has extended the PDUFA action date for the Company’s pending Tyvaso (inhaled treprostinil) NDA. The new PDUFA date is 7/30/09 and UTHR expected the delay (which was announced in a PR in mid-March) due to the submission of additional clinical trial data to the FDA, which was considered a major amendment by the agency. The additional data was related to human factors testing to validate the instructions for using the Optineb nebulizer device which delivers the medication.
 
Auxilium Pharma (NASDAQ:AUXL): On 4/28/09, the FDA accepted for priority review (six-month) Auxilium's BLA for Xiaflex (clostridial collagenase for injection) for the treatment of Dupuytren's contracture (this is a progressive condition that affects the connective tissue that lies beneath the skin in the palm, resulting in collagen deposits which impair normal hand function). AUXL filed the BLA on 2/27/09 and included data from 1,082 subjects and over 2,600 injections. The PDUFA action date is 8/28/09 for the Xiaflex BLA. If approved by the FDA, AUXL plans to launch Xiaflex in the U.S. within 60 days during 2H09.
 
On 2/3/09, BioSpecifics Technologies (NASDAQ:BSTC) received $6.375 million of the $75 million upfront payment paid to AUXL by Pfizer (PFE) and will receive 8.5% of the $410 million in potential additional milestone payments that may be made by PFE to AUXL. Of these additional milestone payments, $150 million are tied to regulatory milestones and $260 million are based on sales milestones. In addition, BSTC will continue to receive milestone and royalty payments from AUXL in accordance with its original agreement for Xiaflex.
 
ISTA Pharma (NASDAQ:ISTA): On 6/1/09, ISTA announced the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) on June 26, 2009. On 11/13/08, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09 for the FDA to complete its review of the pending NDA.
 
Theravance (NASDAQ:THRX): On 4/24/09, the FDA accepted as complete for review Theravance's response to the Agency’s February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a PDUFA action date of 9/16/09 for approval of telavancin in the treatment of cSSSI.
 
Allos Therapeutics (NASDAQ:ALTH): ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA action date of 9/24/09. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.
 
Disclosure: No positions.


March 17

ZixCorp: Close to Securing Profits
Mikerun
   Mike Havrilla   03/17/09  

This pick is about: ZixIt Corp. (ZIXI)
Rating:   Positive   $1.07 (03/17/09)
Closed:   06/27/2009 @ $1.81 (+69.16% in 102 days)
9 pts


ZixCorp: Close to Securing Profits
 
Zix Corp. (ZIXI) is a component in the ETF Innovators Global Health IT Index which offers email encryption and electronic prescribing (e-prescribing) solutions, with the latter poised to experience significant growth thanks to a Medicare incentive program that started this year to encourage prescribers to make the switch from handwritten scripts. The email encryption business accounted for about 81% of 2008 revenue with major clients including hospitals, health insurers, banks, credit unions, and other financial services companies.
 
 
Last month, ZixCorp reported 4Q08 and FY08 revenue of $7.2M and $28M, respectively, compared to $7M and $24.1M in the corresponding periods during 2007. ZIXI ended the year with cash/equivalents of $13.2M and posted a GAAP net loss for FY08 of $5.4M, compared to a loss of $8.1M in 2007. ZixCorp has a market cap around $70M with zero debt and 63.3M shares of common stock outstanding.
 
The Company's email encryption business was strong in 2008, posting 26% annual revenue growth and 83% gross margin. ZIXI expects this business segment to continue posting strong results in 2009, which will add to expected gains in e-prescribing thanks to the Medicare incentive program which encourages adoption of the technology through higher reimbursement levels (in addition to lower payments starting in 2012 for those who do not make the switch).
 
The email encryption business posted 4Q08 and FY08 revenue of $6.1M and $22.6M, respectively, which represents increases of 15% and 26% from the year-ago periods. The ZixDirectory of email encryption users reached a new record level of 14 million members, with a growth rate of about 100,000 new addresses added on a weekly basis.
 
e-Prescribing revenue for 4Q08 and FY08 was $1.1M and $5.4M, respectively, compared to $1.7M and $6.1M in the year-ago periods. The decline was mainly attributable to a decline in fee revenue after reaching a contractual cap in a single program. Several new deals were signed during 4Q08, including Blue Cross in Alabama (up to 300 prescribers), Aetna in New Jersey (AET) (up to 1,000 prescribers), and UnitedHealth in Texas (UNH) (up to 200 prescribers).
 
ZixCorp's PocketScript exceeded expectations for e-prescribing deployment during 4Q08, registering 201 versus guidance of 150 deployments. The PocketScript service processed over 2.2 million e-scripts during 4Q08, bringing the full-year total number of e-scripts processed to 8.6 million (up 16% over 2007).
 
ZixCorp provided 1Q09 revenue guidance of $7.1-7.4M with 250-300 e-prescribing deployments expected. Adjusted earnings per share are expected to show a small loss of between 1-2 cents. ZIXI is also exploring partnerships to reduce costs and broaden the distribution of its e-prescribing technology, although the Company did not provide a specific timeline for any announcements.



January 22

Health IT to Receive Billions from Stimulus Plan
Mikerun
   Mike Havrilla   01/22/09  

This pick is about: Merge Technologies Inc. (MRGE)
Rating:   Positive   $1.52 (01/22/09)
Closed:   06/27/2009 @ $4.3 (+182.89% in 156 days)
9 pts


The table at my website link below presents statistics and the top five rated companies in the ETF Innovators Global Health Information Technology (Health IT) Index, which is structured to include companies with market caps between $50M - $10B. The rating system is based on a formula which considers each company's market cap weighting, net income weighting, and historical stock price returns and the index is equally-weighted among all 52 companies, which is dominated by small-caps with an average market cap of $558M.
 
 
As a new ETF idea, the Top 30 Rated stocks would be chosen as active components and rebalanced each quarter on a semi-active basis. Over the past year, the Health IT Index has outpaced its benchmark ETFs, including Vanguard IT (VGT), Healthcare Sector SPDR (XLV), and Technology Sector SPDR (XLK).
 
The top five rated companies include Swiss telemedicine firm Card Guard (CDGUF) – a provider of remote patient monitoring systems, Merge Healthcare (MRGE) – a clinical + medical imaging information software developer, Quality Systems (QSII) – NextGen electronic medical records system, SXC Health Solutions (SXCI) – pharmacy benefit management + transaction systems, and CardiNet (BEAT) – CardioNet System for real-time, outpatient heart rhythm monitoring.
 
Cerner (CERN) and Allscripts-Misys (MDRX) are two more companies included in the top 30 rated stocks as integrated Health IT plays on electronic prescribing (e-prescribing), medical records, and health information systems. The entire Health IT space is poised to benefit from an expected multi-billion dollar investment (anywhere from $5B to $25B) as part of an overall $800B stimulus plan.
 
However, the expected benefit for Health IT companies may not materialize until 2010 as it will take some time for the expected government grants to encourage purchases of new technology by hospitals and clinics. Also, prescribers are encouraged to adopt e-prescribing in the form of financial incentives through Medicare reimbursement and will be penalized if they do not adopt the technology by 2012.


February 28

Health Benefit Providers Index Drops on Reform Prospects
Mikerun
   Mike Havrilla   02/28/09  

This pick is about: UnitedHealth Group Inc (UNH)
Rating:   Negative   $19.19 (02/28/09)
Closed:   06/27/2009 @ $24.77 (-29.08% in 119 days)
9 pts


The accompanying table includes 38 companies in the ETF Innovators Health Benefit Providers Index, which was down sharply in the past week and has lost 14% of its market value to a level of 192,305 since I last wrote about the group five weeks ago.

The uncertain future for health insurers and benefit providers that I wrote about previously came to a head this week with plans by President Obama for healthcare reform aimed at cutting health costs by favoring generic drug makers and smaller Medicare Advantage payments to private insurers, along with smaller increases in Medicare Advantage reimbursement for 2010 than was expected.

Stocks in the Health Benefit Provider Index which posted major losses in the past month include:

1.) UnitedHealth Group (UNH) -32%

2.) Aflac (AFL) -24%

3.) WellCare Health Plans (WCG) -38%

4.) Humana (HUM) -39%

5.) Universal American (UAM) -34%

6.) Aetna (AET) -24%

Only four companies in the index managed to post a stock price gain in the past year, including PharMerica (PMC), Omnicare (OCR), Amerisafe (AMSF), and America Service Group (ASGR). The group of gainers carried a common theme of providing specialized health benefit services, including PMC - an operator of hospital pharmacies, OCR - pharmacy services + distribution for long-term care facilities, AMSF - workers compensation insurance, and ASGR - managed healthcare services for correctional facilities.

Express Scripts (ESRX) and MedcoHealth Solutions (MHS) are two pharmacy benefit managers which are poised to gain on the prospects for bio-generics and other provisions designed to encourage the use of generic medications, which results in higher profit margins for these companies.

 



November 01

Health Benefit Providers Need a Check-Up
Mikerun
   Mike Havrilla   11/01/08  

This pick is about: Aetna Inc (AET)
Rating:   Negative   $24.84 (11/01/08)
Closed:   06/27/2009 @ $25.2 (-1.45% in 237 days)
9 pts


Health Benefit Providers Need a Check-Up



The accompanying table provides statistics and the top seven companies by market cap for the ETFI Health Benefit Providers Index & short ETF proposal of 33 companies with market caps over $100M, which includes all types of pharmacy services (retail, mail order, institutional), pharmacy benefit managers, managed care companies, health insurers, and supplemental health insurance. The 25 lowest rated companies in the index have lost nearly half of their market value in the past year, underperforming the Healthcare Sector SPDR (XLV), iShares Dow Jones U.S. Healthcare Providers (IHF), and the S&P 500 SPDR (SPY).

Former investor favorites in the industry such as Aetna (AET), UnitedHealth (UNH), WellPoint (WLP), and Humana (HUM) have lost more than half of their market value in the past year on concerns of declining profits, Medicare spending cuts, and the possibility for increased government regulation – such as Senator Obama's proposal to mandate coverage of pre-existing conditions. Other companies included in the index such as Rite Aid (RAD), CVS Caremark (CVS), and Walgreen (WAG) face the prospect of decreased consumer spending and intense competition from the likes of Wal-Mart (WMT) with its extensive $4 generic drug program.


 
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Avg exp holding time:
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