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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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July 21

FDA Calendar: Five Weight Loss Trades
Mikerun
   Mike Havrilla   07/21/09  

This pick is about: Orexigen Therapeutics Inc. (OREX)
Rating:   Positive   $7.52 (07/21/09)
Closed:   07/09/2010 @ $4.33 (-42.42% in 353 days)
9 pts


Below are five small/micro-cap companies from the <font> BioMedReports.com FDA Calendar </font> with late-stage drugs or medical devices in development for prescription weight loss. Nearly two-thirds or 65% of U.S. population is classified as obese or overweight with a three-fold increase in adolescent obesity rates over the past three decades. Obesity is the second leading cause of preventable deaths behind smoking and weight loss is proven to decrease mortality while also improving blood sugar control in diabetics. Over one-third (35%) of people in the U.S. have a lifetime of developing Type 2 diabetes and the trend is clearly increasing as a result of obesity rates, especially in the younger population.
 
 
On 3/30/09, Arena Pharma (NASDAQ:ARNA) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfied the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study. Arena is on track to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end.
 
Vivus (NASDAQ:VVUS) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa. Qnexa is a once-daily, combination drug (phentermine 15 mg immediate-release + topiramate 92 mg controlled-release) in Phase 3 clinical development for weight loss in obese patients and improving blood sugar control in diabetics. Phentermine is the most widely prescribed prescription weight loss drug which is available in generic forms and has a database of 1.8 million patient years of usage.
 
Topiramate is better known as Topamax (patent expires this month), which has 5.8 million patient years of use and was originally developed as a seizure drug and is also used for the prevention of migraine headaches. While both components of Qnexa will be available in generic forms, topiramate is not indicated for weight loss and the dosages being evaluated in clinical trials would make dosing difficult using the two drugs individually.
 
Vivus holds composition of matter and method of use patents for Qnexa as a combination treatment for obesity in the unique dosage forms being evaluated in Phase 3 clinical trials, with more than 4,500 patients currently enrolled in late-stage studies for weight loss and Type 2 diabetes control. Last year, Vivus reported results for Qnexa from the 28-week EQUATE Phase 3 clinical trial which met its primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the drugs used individually and placebo.
 
On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.
 
OREX is continuing to follow patients in a Phase 2b clinical trial of Empatic (zonisamide SR/bupropion SR), ZB-202. The trial is designed to build on the results from a previous Phase 2b trial of Empatic, ZB-201. In the current trial, which measures weight loss after 24 weeks of treatment, two different dosages of Empatic are being studied along with the individual constituents. The Company expects to report results from this Phase 2b clinical trial during 3Q09.
 
EnteroMedics (NASDAQ:ETRM) is developing implantable systems to treat obesity and other gastrointestinal disorders. VBLOC Therapy intermittently blocks nerve signaling between the brain and stomach over the vagus nerves using high-frequency, low-energy electrical impulses. The vagus nerves are known to control digestive functions including food processing and feelings of hunger and fullness. In blocking nerve function, VBLOC is designed to help patients feel hungry less and feel full sooner, therefore reducing how much they eat.
 
The effect of VBLOC Therapy has been demonstrated in early clinical trials, where patients reported reduced time to feelings of fullness at meals, as well as reduced feelings of hunger between meals out to six months with resultant reduced calorie intake. The EMPOWER study is a randomized, double-blind, placebo-controlled pivotal clinical trial that reached its target enrollment of 294 patients in September 2008. ETRM expects results from the blinded portion of the study during 2H09, which will be used for a Premarket Approval (PMA) Class III medical device submission to the FDA for marketing clearance.
 
On 6/8/09, NeuroSearch (CPH:NEUR) 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


July 08

Trading FDA, Clinical Trial Binary Events: Nephros, Vivus
Mikerun
   Mike Havrilla   07/08/10  

This pick is about: VIVUS Inc. (VVUS)
Rating:   Positive   $10.67 (07/08/10)
Closed:   07/09/2010 @ $11.69 (+9.56% in 1 day)
9 pts


Below are summaries of the most recent articles written by Mark Messier at <font> www.BioRunUp.com </font> <font> -- please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing. </font>

<font> Nephros (OTCBB:NEPH) Receives 510(k) Response from the FDA </font>

<font> Posted: Thu, 08 Jul 2010 09:30:43 +0000 </font>

<font> Within a time span of a few months in 2009, NEPH went from $.04 to $2.63 and fueled the biotech fire. However all of Nephros' applications to the FDA were 510K (medical devices), and thus given no catalyst date.  Take a look at the chart for NEPH: Time has dragged on, and over a year [...] </font>

<font> Transparency in Trading </font>

<font> Posted: Wed, 07 Jul 2010 09:30:42 +0000 </font>

<font> In 2009 the markets were roaring back after a steep decline.  You could practically throw a dart at a dartboard full of stock tickers, and pick a winner.  Times have changed. The market has slowed, if not reversed, and it is much more difficult to pick winners, or even to pick methods that are consistently effective.  I [...] </font>

<font> Another Great Resource - The Office of the Federal Register </font>

<font> Posted: Tue, 06 Jul 2010 09:30:56 +0000 </font>

<font> Published every Federal working day, the Federal Register is the official gazette of the United States Government. It provides legal notice of administrative rules and notices and Presidential documents in a comprehensive, uniform manner. Documents are on file at the Office of the Federal Register (OFR) and will be published in the Federal Register on [...] </font>

<font> This Week's Watchlist 7/5/10 </font>

<font> Posted: Mon, 05 Jul 2010 05:55:35 +0000 </font>

<font> Note: The US stock market is closed on Monday in observance of the 4th of July holiday. Vivus (NASDAQ:VVUS) remains on the weekly watchlist as activity and interest in the company should pick up this week and into next week's FDA Panel on 7/15.  For those playing the run-up, remember that the FDA releases [...] </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. </font>

<font> <font> The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 594 entries and 397 companies (including approximately 200 stocks trading under $5 per share and 57 private companies). Subscribers also have access to my real money portfolio tracker, Google Calendar event tracking for over 1,000 stocks in the HavRx Indexes, and real-time trading / article updates on the member forum. Click on the following email archive web link for a 50% discount promo code... </font> </font> <font> http://eepurl.com/FWdn </font> <font> </font>

<font> Disclosure: No positions </font>



September 18

BioMed News Bytes: Arena (NASDAQ: ARNA), Momenta (NASDAQ:MNTA), Vivus (NASDAQ: VVUS)
Mikerun
   Mike Havrilla   09/18/09  

This pick is about: VIVUS Inc. (VVUS)
Rating:   Positive   $11.63 (09/18/09)
Closed:   07/08/2010 @ $10.67 (-8.25% in 293 days)
9 pts


On 9/18/09, Arena Pharma (NASDAQ: ARNA) ($5.32, +9%) (heavy, above-average volume) announced lorcaserin met all primary endpoints and FDA benchmark with 63% of patients who complied with the protocol losing at least 5% of their weight. ARNA plans to file a NDA with the FDA in December. However, patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo, causing shares of ARNA to initially decline on the news (with a recent turnaround and uptick) based on concerns for the commercial prospects of lorcaserin compared to Qnexa from Vivus (NASDAQ: VVUS) ($11.51, +9%) (heavy, above-average volume), which is trading up on the lorcaserin results despite announcing a secondary offering of 9 million shares at a price of $10.50. <o:p> </o:p>

<o:p>   </o:p>

http://www.mikehavrx.com/2009/09/biomed-news-bytes-arena-nasd... <o:p> </o:p>

<o:p>   </o:p>

On 3/30/09, ARNA announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfy the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study. <o:p> </o:p>

<o:p>   </o:p>

On 9/18/09, Momenta Pharma (NASDAQ: MNTA) ($11.47, +3%) (above-average volume) was started with a buy rating by Deutsche Securities and the Company provided guidance at last week’s Rodman Healthcare conference that it is cautiously optimistic on the chances for approval of M-Enoxaparin by the end of 2009 and believes that the FDA has all the required data for a decision on the pending ANDA. In addition, MNTA will present full Phase 2a data on its proprietary anti-coagulant compound M118 at an upcoming conference on 9/24/09 while seeking a partnership to fund further clinical development and potential commercialization. <o:p> </o:p>

<o:p>   </o:p>

Click here for my overview article on MNTA at BioMedReports.com published in March which describes the Company’s three-part strategy that includes complex generics in partnership with Sandoz, proprietary compounds, and follow-on- biologics (FOB). <o:p> </o:p>

<o:p>   </o:p>

Momenta is partnered with the Sandoz division of Novartis (NYSE: NVS) to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company expired in April for Amphastar + partner Watson Pharma (NYSE: WPI). <o:p> </o:p>

<o:p>   </o:p>

The other company with a pending ANDA for Lovenox is Teva Pharma (NASDAQ: TEVA), which is also involved in litigation with Sandoz over the Copaxone ANDA. In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA on the immunogenicity of their products. 9/26/08 is the date that Sandoz submitted its complete response to the FDA for the abbreviated new drug appplication (ANDA), and the Generic Drug Division does not issue formal decision date deadlines. <o:p> </o:p>

<o:p>   </o:p>

Sandoz filed its abbreviated new drug application (ANDA) for a generic version (M356) of Teva's multiple sclerosis drug Copaxone (glatiramer acetate injection) ($2.3B in sales for 2008) on 12/27/07 which was accepted for review by the FDA on 7/11/08. Sandoz is currently involved in litigation with TEVA over M356 as a generic equivalent which was filed with a Paragraph IV Certification. The P4 notification officially informed Teva that the M356 ANDA contains a certification of the patents listed for Copaxone in the FDA's Orange Book are either invalid or not infringed. <o:p> </o:p>

<o:p>   </o:p>

In April 2009, the FDA declined to review the citizen petition submitted by TEVA asking the agency not to accept applications for generic versions of the Copaxone multiple sclerosis treatment. The agency told Teva that it would be “premature and inappropriate” to review the Copaxone (glatiramer acetate) petition filed last September. A product cannot be launched until after the 30 month litigation stay (Feb. 2011) -- can then launch at risk if ANDA approved. <o:p> </o:p>

<o:p>   </o:p>

On 9/14/09, Mylan (NYSE: MYL) announced that the FDA accepted the Company’s ANDA for filing, seeking approval of Glatiramer Acetate Injection (20 mg/mL) as a generic version Copaxone. As previously announced, Mylan entered into a license and supply agreement with NATCO Pharma Ltd. which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the U.S. and other major global markets. <o:p> </o:p>

<o:p>   </o:p>

Disclosure: No positions. See my full disclaimer at MikeHavRx.com at the bottom of any page. <o:p> </o:p>



November 13

Updated FDA Calendar of Decision Dates
Mikerun
   Mike Havrilla   11/13/08  

This pick is about: XenoPort Inc. (XNPT)
Rating:   Positive   $30.97 (11/13/08)
Closed:   07/07/2010 @ $6.59 (-78.72% in 600 days)
9 pts


Updated FDA Calendar of Decision Dates


The accompanying table of FDA decision dates is updated to include the following: 1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK); 2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09; 3) Genentech (DNA) filed for accelerated approval of Avastin as a secondary treatment of brain cancer (glioblastoma) based on positive clinical trial results. Also, the backlog of decision dates I wrote about last week still remains -- with only DSCO hearing back from the FDA on the decision to classify Surfaxin as a Class II review, which is probably more of a reflection of the agency's understaffed conditions rather than an issue with the complete response for the drug.


June 23

Trading FDA, Clinical Trial Binary Events at BioRunUp.com: $ISTA $ARNA $VVUS $ISA.TO
Mikerun
   Mike Havrilla   06/23/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $81.15 (06/23/10)
Closed:   07/07/2010 @ $75.69 (-6.73% in 14 days)
8 pts


Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com - please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing.

<font> ISTA - sNDA for XiDay with a PDUFA Date of 10/16/10 </font>

<font> ISTA (ISTA Pharmaceuticals) is another company with a drug up for an October FDA Approval. As recently as last month ISTA was trading in the $4 range, and has currently dipped into the mid $2 range.  I expect to see $5 - $6 during the run-up to the October 16th PDUFA date.  It has a [...] </font>

<font> ARNA - Two Upcoming ADA Conference Presentations (With Abstracts) </font>

<font> Press Release from ARNA below: SAN DIEGO, June 17, 2010 - /PRNewswire-FirstCall/ - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that new data analyses from lorcaserin's pivotal Phase 3 clinical trial program will be presented in poster sessions at the American Diabetes Association's 70th Scientific Sessions in Orlando, Florida. The two posters highlighted below will be displayed in the [...] </font>

<font> VVUS - Six Upcoming ADA Conference Presentations (With Abstracts) </font>

<font> Vivus (NASDAQ:VVUS) just announced that it has a total of 6 upcoming presentations at the 70th Annual ADA (American Diabetic Association) conference (June 25-29, 2010).  These presentations will include reviews of Qnexa's data, and may have an impact on share price.  Below you will find text from Vivus' press release with a link to each abstract [...] </font>

<font> ISA.TO Run-Up Right on Schedule </font>

<font> Today ISA.TO (IPHAF) hit a 52 week hight at $.43, trading at over 8x its average daily volume.  On June 3rd I published an article on ISA.TO (see link here) when the price was at $.27, recommending a buy before the run-up began.  Today's peak represented a 60% gain in price and we still have [...] </font>

<font> Are You Unhappy With BioMedReports.com? </font>

<font> Are you unhappy with BioMedReports.com?  I know that I am.  I have been a paid subscriber since August of 2009.  In March of 2010 I requested to have the unused part of annual my membership refunded.  This request was quickly rejected with the reply "Unfortunately there are no refunds".  To add insult, BioMedReports (BMR) is [...] </font>

<font> This Week's Watch List 6/21/10 </font>

<font> ISA.TO (IPHAF) - #1 on the Watchlist this week is Isotechnika Pharma.  On Monday of next week (June 28th) they have an FDA Advisory Panel for their main drug, Voclosporin. A reminder to those who are new to trading FDA Panel catalysts, the FDA releases the official "notes" to the meeting a few days ahead [...] </font>

<font> FDA Calendar Updates 6/18/10 </font>

<font> CLDA - PDUFA for drug Vilazodone 1/22/11 PLX - UNCONFIRMED FDA Date for ULYPSO (Orphan Status and Priority Review) 10/27/10 ALKS - FDA Panel for Vivitrol 9/16/10 </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 599 entries and 396 companies (including approximately 200 stocks trading under $5 per share and 49 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



April 08

FDA, Clinical Trial News: $FRX $HTWR $DRRX $KG
Mikerun
   Mike Havrilla   04/08/10  

This pick is about: Forest Laboratories Inc (FRX)
Rating:   Negative   $32.46 (04/08/10)
Closed:   07/06/2010 @ $27.49 (+15.31% in 89 days)
9 pts


Shares of Forest Labs (NYSE:FRX) are losing about 8.5% during after-hours trading this evening on news that an FDA Advisory Panel voted 10-5 against recommending approval for an experimental, once-daily oral treatment for COPD (chronic obstructive pulmonary disease). FRX licensed the US rights to Daxas (roflumilast) from privately held Nycomed and a final FDA decision is expected to be announced by next month.

<font> After the stock market close, HeartWare (NASDAQ:HTWR) announced FDA approval of an Investigational Device Exemption (IDE) Supplemental filing that allows the Company to enroll up to an additional 54 patients in its ongoing pivotal ADVANCE study under a Continued Access Protocol (CAP). HTWR expects to reach the 180-day follow-up period for the final patient by the end of August and file for FDA approval in December for its Ventricular Assist System as a bridge to heart transplantation for end-stage heart failure. </font>

<font> On 4/7/10, Durect Corp.'s (NASDAQ:DRRX) licensee King Pharma (NYSE:KG) initiated a 12-week, randomized Phase 2b study that is expected to enroll 260 patients for the treatment of chronic low back pain. ELADUR (TRANSDUR-Bupivacaine) is a skin patch that releases the long-acting local anesthetic drug bupivacaine over a three-day period. </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials (currently tracking 375 entries, 242 total companies, and 129 stocks under $5 per share), which are tracked in the actively managed HavRx Regulatory Catalyst Index.   NEW!  50% discount promo codes are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



June 20

Trading FDA, Clinical Trial Binary Events: Real Money Portfolio Tracking
Mikerun
   Mike Havrilla   06/20/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $83.37 (06/20/10)
Closed:   06/23/2010 @ $81.15 (-2.66% in 3 days)
9 pts


<font> Following the announcement last week </font> <font> that the virtual / social investing website MarketGuru.com will be closing by the end of June, I have synced my TD Ameritrade online brokerage account with a new free service offered by wikinvest.com that includes a variety of portfolio tracking and monitoring tools. </font>

<font> There is currently no widget available to share or display this information automatically on other websites, but I will be posting manual daily updates with a summary of my real money portfolio holdings and other tracking statistics in the form of a screen capture image on the subscriber home page which is taken from my secure wikinvest.com portfolio tracking account. </font>

<font> </font>

<font> </font>

<font> The daily portfolio tracking reports now available at the subscriber home page include the following information from my TD Ameritrade online brokerage account: stock name / ticker, daily change, number of shares owned, cost basis in total dollars for each stock owned, daily trading volume, 52-week range, market cap, and the total gain / loss percentage for each of my positions. addition, I will manually update a screen shot image along the left column of the website to display a performance tracking chart and statistics for my account. </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 594 entries and 390 companies (including approximately 200 stocks trading under $5 per share and 45 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>


January 23

Index to Track New Era for Stem Cell Cos.
Mikerun
   Mike Havrilla   01/23/09  

This pick is about: Aastrom Biosciences Inc. (ASTM)
Rating:   Positive   $0.6989 (01/23/09)
Closed:   06/22/2010 @ $1.48 (+111.76% in 515 days)
1 pt


Index to Track New Era for Stem Cell Cos.
 
Shares of Geron (GERN) are soaring today by more than 40% on FDA approval to begin human clinical testing this summer for an embryonic stem cell treatment for spinal cord injuries. The approval comes just days after the new administration took office, breathing new life into related companies such as StemCells (STEM), Aastrom Biosciences (ASTM), and others tracked in the ETF Innovators Cosmetic & Reconstructive Medicine Index.
 
This index and new ETF idea represents a first-to-market idea to provide investors with an exchange-traded product to invest in a basket of regenerative medicine and stem cell companies such as Osiris (OSIR), Genzyme (GENZ), Cytori Therapeutics (CYTX), Mesoblast (MBLTY), Integra LifeSciences (IART), and Kinetic Concepts (KCI) (LifeCell acquisition). The index includes 79 companies engaged in cosmetic medicine, regenerative medicine + stem cells, orthopedic repair, joint replacements, and cardiovascular (heart + blood vessels) treatments.
 
As a semi-active ETF idea, this product would be rebalanced each month to select the top 35 rated companies with market caps over $100M as equally-weighted active components based on a variety of factors, including market cap weighting, revenue weighting, historical stock price return, and others.
 
 
The table at my website link above includes the top seven rated regenerative medicine + stem cell companies and full index statistics over the past year, with favorable results compared to the Healthcare Sector SPDR (XLV), iShares Nasdaq Biotech (IBB), SPDR S&P Biotech (XBI), and S&P 500 SPDR (SPY). Other favorable trends for this index include a bias toward small/mid-cap companies, making them takeover targets – as evidenced by the Johnson & Johnson (JNJ) buyout of breast implant maker and former index component Mentor.


June 16

Trading FDA, Clinical Trial Binary Events: MarketGuru.com Site Closing
Mikerun
   Mike Havrilla   06/16/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $82.88 (06/16/10)
Closed:   06/20/2010 @ $83.37 (+0.59% in 4 days)
9 pts


The following alert was posted today on the social / virtual investing site at MarketGuru.com regarding the site being closed down by the end of the month...

<font> ...MarketGuru was founded in January of 2008 and like many other companies, we were hit with the world financial crisis which made it difficult to find investors for our project...Our real frustration is our complete faith that social investing works. We KNOW that MarketGuru makes investors better and this knowledge makes it that much more difficult to give up and abandon ship. We should be around till the end of the month or so. Best wishes to you all. </font>

<font> Below is a chart of my final performance statistics at MarketGuru.com / mikehavRx compared to the Dow Jones Industrial Average and NASDAQ Composite Index since I began using the site in December 2008, with the strongest results posted year-to-date in 2010 that include a gain in excess of 130% based on a focused strategy of small / micro-cap bio-pharma stocks and utilizing the research included in the daily Regulatory Catalyst Index updates. </font>

<font> </font>

<font> I am currently considering several options to provide a low-cost and simple way for people to invest in the 18 HavRx Stock Indexes, including potential exchange-traded fund (ETF) licensing deals, Investars YOU personalized stock index investing, and Folio Investing as a Registered Investment Advisor (RIA). Stay tuned to the site for more details on any or all of these options. In the meantime, the subscriber home page has been completely revamped along with several new features for members such as a daily Regulatory Catalyst Watch List report, forum, etc. </font> <font> described in this overview article </font> <font> . </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 591 entries and 385 companies (including approximately 200 stocks trading under $5 per share and 40 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>


June 12

Tracking FDA, Clinical Trial Binary Events and Healthcare Niche Indexes at mikehavRx.com
Mikerun
   Mike Havrilla   06/12/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $81.24 (06/12/10)
Closed:   06/16/2010 @ $82.88 (+2.02% in 4 days)
9 pts


New features have been added for subscribers to mikehavRx.com Index Updates to provide time-saving information for subscribers to take charge of their investments. The premium service is provided in the form of 23 PDF files located on the redesigned home page, including 17 files for each of the passively managed stock index components and six reports for the actively managed Regulatory Catalyst Index.

<font> - third party performance tracking for the 18 HavRx stock indexes provided by Investars YOU </font>

<font> - social / virtual investing performance tracking at </font> <font> www.marketguru.com/mikehavRx </font> <font> </font>

<font> - a stock trading / investing forum provides a platform for subscribers to interact and discuss ideas and strategies </font>

<font> - </font> <font> mikehavRx.com Index Updates is now listed at Investimonials.com </font> <font> for users to post reviews and rate the service </font>

<font> - integrated news feeds for FDA, clinical trial, stock market, and medical news </font>

<font> - collaboration with </font> <font> www.BioRunUp.com </font> <font> to provide articles and Twitter (@BioRunUp) (@mikehavrilla) updates on binary event investing / trading strategies and news </font>

<font> - integrated Google Calendars tracking upcoming presentations, quarterly conference calls and other corporate events for over 1,000 stocks being tracked in the 18 HavRx Stock Indexes </font>

<font> - a new Regulatory Catalyst Watch List report (daily PDF report and live tracking stock widget formats) includes up to 50 stocks and is updated daily along with the five other binary event tracking reports to provide a starting point for members to conduct further research </font>

<font> - the five daily Regulatory Catalyst Index Update reports are currently tracking over 575 events related to FDA and clinical trials and over 375 companies, including approximately 200 stocks trading under $5 per share and 36 private companies </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 584 entries and 381 companies (including approximately 200 stocks trading under $5 per share and 36 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>



June 05

FDA, Clinical Trial Stocks and Healthcare Niche Indexes Outpace Markets
Mikerun
   Mike Havrilla   06/05/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $80.26 (06/05/10)
Closed:   06/12/2010 @ $81.24 (+1.22% in 7 days)
9 pts


Despite the recent market volatility and downward move in the major market averages with the Dow Jones Industrial Average closing below 10,000; the actively managed <font> HavRx Regulatory Catalyst Index </font> <font> has posted a gain exceeding 100% in the past year. Other notable returns among the 17 passively managed sub-sector, niche healthcare and transport indexes since June 2009 performance tracking on an equal-weight basis at Investars YOU include small / micro-cap cancer diagnostic / therapeutic companies, generic drugs, health benefit providers, hospitals / healthcare facilities, the railroad industry, air transport stocks, and the tobacco industry. </font>

<font> </font>

<font> </font>

<font> The largest companies in the healthcare sector have posted weak returns, with the HavRx Life Science leaders of 25 stocks posting a 12% decline over the past six months. However, the niche sub-sector indexes comprised of small and mid-cap stocks have posted strong returns, highlighting the advantages of a selective investing strategy to outpace the overall market and sector returns based on industry groups with solid fundamental growth and those driving medical innovation. </font>

<font> Over the past year, the returns of sector-based exchange-traded funds include Healthcare Sector SPDR (NYSE:XLV) (+10.3%), Consumer Staples Sector SPDR (NYSE:XLP) (+12.8%), and iShares Dow Transports (NYSE:IYT) (+31.1%). Notable sub-sector ETFs over the past year include Claymore/NYSE Arca Passenger Airlines (NYSE:FAA) (+75%), iShares NASDAQ Biotech (NASDAQ:IBB) (+18.7%), iShares Dow Jones US Medical Devices (NYSE:IHI) (+30%), and PowerShares Dynamic Healthcare Services (NYSE:PTJ) (+31.6%). </font>

<font> In addition to the global equity indexes outlined above, </font> <font> my article at Seeking Alpha from December 2008 </font> <font> outlines an idea for an index to define an equal-weight composite index to track global coal prices comprised of near-month futures from each of the major coal exporting regions in the world, including (1) NYMEX US Central Appalachian Coal [QL], (2) Intercontinental Exchange (ICE) Futures EU Rotterdam [ATW], (3) ICE Futures South Africa Richards Bay [AFR], and (4) ICE Futures - globalCOAL Asia-Pacific (Newcastle, Australia) [NEWC Index]. </font>

<font> Such an index could be developed as an exchange-traded note (ETN) product to track this key energy commodity, which currently has no exchange-traded product (ETP) on the market and is currently only available in the form of futures trading. Similar ETPs for other key energy commodities include the US Oil Fund (NYSE:USO) and the US Natural Gas Fund (NYSE:UNG) with over $3 billion in assets while products for carbon credits such as the iPath Global Carbon ETN (NYSE:GRN) and the now defunct AirShares EU Carbon Allowances have failed to garner interest from investors in the form of net assets and trading volume. </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 577 entries and 375 companies (including approximately 200 stocks trading under $5 per share and 31 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



April 23

Event Calendar Tracking Added for mikehavRx.com Subscribers
Mikerun
   Mike Havrilla   04/23/10  

This pick is about: iShares Dow Jones Transportation Average Index Fund (IYT)
Rating:   Positive   $85.6 (04/23/10)
Closed:   06/05/2010 @ $75.43 (-11.88% in 43 days)
9 pts


mikehavRx.com Index Updates is a premium service that provides investors with time-saving information and updates on global baskets of stocks (over 1,000 stocks) that are organized and managed within the 18 HavRx Stock Indexes. The service is provided in the form of 22 PDFs at the subscriber home page which can be accessed upon successful log-in. This is a no-hype, information-based service focused on the healthcare sector and medical innovation that is designed for self-directed investors and traders.

<font> An additional Google Calendar has been added to the subscriber home page to track upcoming quarterly conference calls, presentations, and related events for companies being tracked in the 17 passively managed HavRx stock indexes. This adds to the recently added Google Calendar for the Regulatory Catalyst Index active components and watch list stocks (over 300 stocks), which complements the five daily update reports for binary event tracking data. </font>

<font> The Regulatory Catalyst Index reports are updated daily on regular business days between 6-8pm (ET) and the five reports are sorted by company name, stock ticker, catalyst date, stock price, and the date of most recent update for each entry. Regulatory Catalyst Index update statistics (as of 4/23/10) are summarized below. </font>

<font>      - 503 total entries to track select pending binary event data (FDA decisions, clinical trials) </font>

<font>      - 308 companies tracked, including 115 active index components </font>

<font>      - 226 companies under $10 per share, 169 companies under $5 per share </font>

<font> Below is the updated performance tracking statistics and data for the HavRx stock indexes, representing subsector indexes and new exchange-traded fund ideas as follow-on products to popular sector-based ETFs such as the Healthcare SPDR (XLV), iShares Dow Jones Transports (IYT), and iShares NASDAQ Biotech (IBB). </font>

<font> HavRx Index Stats as of 23-April 2010, Tracking Start Date, # Stocks, Last Price, % Chg </font>

<font> Healthcare Stock Indexes (13) 
   
Regulatory Catalyst 6/21/09 115 $2,126.81 112.7%
Diabetes Care 11/19/09 46 $1,193.54 19.4%
Cosmetic / Restorative Medicine 6/24/09 78 $1,419.82 42.0%
Life Science Leaders 12/15/09 25 $1,000.41 0.0%
Natural Health 12/15/09 52 $1,094.89 9.5%
Immune Therapy / Vaccines 12/15/09 52 $1,298.06 29.8%
Emerging Cancer Dx / Tx 6/21/09 85 $2,125.45 112.5%
Global Generic Drugs 6/24/09 75 $1,685.82 68.6%
Global Health IT 6/24/09 55 $1,403.10 40.3%
Global Hospitals 6/28/09 51 $1,443.44 44.3%
Stem Cells 6/22/09 48 $1,340.88 34.1%
Health Benefit Providers 6/21/09 54 $1,549.40 54.9%
Global Crop Science 12/17/09 48 $1,048.23 4.8% </font>

<font> Non-Health Stock Indexes (5) 
   
Global Clean-Tech 6/21/09 58 $1,360.28 36.0%
Global Railroad Industry 6/24/09 46 $1,580.24 58.0%
Global Tobacco Industry 6/21/09 21 $1,560.12 56.0%
Global Trucking / Logistics 6/24/09 47 $1,382.25 38.2%
Global Air Transport 6/24/09 48 $2,137.33 113.7% </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 502 entries and 308 companies (including over 150 stocks trading under $5 per share). Promo codes (50% discount) are also available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



January 22

1-Year Analysis of Coal Price vs. Energy Commodity Funds
Mikerun
   Mike Havrilla   01/22/09  

This pick is about: United States Natural Gas Fund LP (UNG)
Rating:   Positive   $19.0 (01/22/09)
Closed:   06/05/2010 @ $8.18 (-56.95% in 499 days)
9 pts


The chart below depicts a one-year analysis of near-month Central Appalachian Coal Futures Contract Prices (NYMEX: QL), the Market Vectors Coal Company ETF (KOL), the U.S. Oil Fund (USO), the U.S. Natural Gas Fund (UNG), and the S&P 500 SPDR ETF (SPY). QL fared the best with a minor decline of 0.3%, compared to major losses of 61.4% for KOL, 58% for USO, 49.1% for UNG, and 34.7% for SPY. The chart was constructed using the daily closing prices for each component.
 
 
The prices for coal futures from other areas of the world were excluded in the chart analysis to avoid congestion from too many data points and since the correlation is high (around 95%) to QL. The table below illustrates the high correlation of global coal prices and low correlation of about 64% for Central Appalachian coal prices and KOL over the past year.
 
KOL illustrates a much higher correlation to the overall market (SPY) of about 92% versus a low correlation for the price of coal to SPY at just 45%. USO and UNG also demonstrate high correlations to SPY of 86% and 83%, respectively. Below are the details for the futures contracts analyzed in the correlation matrix as a proxy for the global price of coal, representing the major global exporters of coal.
 
1.) United States: NYMEX Central Appalachian Coal Futures (QL)
 
2.) Europe: Intercontinental Exchange (ICE) Futures Rotterdam (ATW)
 
3.) South Africa: ICE Futures Richards Bay (AFR)
 
USO and UNG demonstrated correlation of about 90% while QL was much more correlated to USO (78%) as compared to UNG (56%). However, KOL demonstrated a high correlation of over 92% each for UNG, USO, and SPY. The following factors warrant development of a new exchange-traded commodity product to track either the global or U.S. price (or both) of coal:
 
1.) the low correlation of coal prices to the overall market and other energy commodities
 
2.) the importance of coal in the global energy markets and power generation
 
3.) the lack of a exchange-traded product for coal prices
 
4.) the low correlation of the coal stock ETF (KOL) to coal prices
 
Such a CoalFund could be developed as a new investment vehicle to provide investors with exposure to the performance of near-month futures contracts for the global price of coal from the major coal producing and exporting regions in the world, the United States, or both. In addition the U.S., Europe, and South African coal futures contracts outlined above; a new product recently began trading as proxy for Australian coal futures on the Intercontinental Exchange (ICE) – the ICE Futures globalCOAL Newcastle Coal Futures Contract.


June 01

History of Success Trading FDA Catalyst Events: $CAMH, $AEN, $NVLT, $GTHP, $CTIC
Mikerun
   Mike Havrilla   06/01/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $79.7 (06/01/10)
Closed:   06/05/2010 @ $80.26 (+0.70% in 4 days)
9 pts


<font> Written by Mark Messier (BioRunUp.com) </font> <font> . I would like to point out some of the benefits that I personally have experienced by taking advantage of my membership to Mike Havrilla's website at  </font> <font> MikeHavRX.com </font> <font>  over the past year.  Lets take a look at some of my picks using Mike's Biotech Regulatory Catalyst Index and how they have performed.  </font>

<font> If you question when I picked them and the price on the day of my pick, click on the link that takes you to the  </font> <font> MyStockBuddy.com </font> <font>  forum where the threads were started. </font>

<font> CAMH </font> <font> <font>  - Cambridge Heart
Price at "Discovery": $.13
Date of "Discovery":  2/22/10
Peak Price: $.75
Date of Peak Price:  4/15/10
Potential Profit:  477% </font> </font>

<font> AEN </font> <font>  - Adeona Pharmaceuticals  </font>
<font> Price at "Discovery": $.70
Date of "Discovery": 9/7/09
Peak Price: $2.70
Date of Peak Price: 3/30/10
Potential Profit: 286% </font>

<font> NVLT </font> <font> <font> - Novelos Therapeutics
Price at "Discovery": $.85
Date of "Discovery": 7/2/09
Peak Price: $3.05
Date of Peak Price: 01/04/10
Potential Profit: 259% </font> </font>

<font> GTHP </font> <font> <font> - Guided Therapeutics
Price at "Discovery": $.36
Date of "Discovery": 10/05/09
Peak Price: $1.70
Date of Peak Price: 11/20/09
Potential Profit:  372% </font> </font>

<font> Conclusion </font>

<font> I believe that one of the best ways to make big gains in trading biotech is to get in early.  Many times, by the time you hear about some of these plays from websites, forums, or email subscriptions, the biggest pop in price has already occurred. </font>

<font> This is exactly why I have been following Mike Havrilla's calendar updates for almost a year now.  He provided the information for BioMedReports FDA calendar up until a few months ago when he broke away from their advancing pump and dump schemes. Mike is now running his own calendar and biotech investor website which is updated daily with 10-20 new calendar items, as well as integration with Google Calendar and BioCatalyst Index Tracking. </font>

<font> I encourage you to check out his site and consider signing up.  I am confident that by combining the methods on  </font> <font> BioRunUp.com </font> <font>  with the unbiased research on  </font> <font> MikeHavRX.com </font> <font>  you will become a more profitable trader. </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 568 entries and 364 companies (including approximately 200 stocks trading under $5 per share and 25 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



May 16

Near-Term FDA, Clinical Trial Extreme Trades: $ACCP.OB, $APPY, $AVNR, $BMOD.OB, $CYCC
Mikerun
   Mike Havrilla   05/16/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $85.18 (05/16/10)
Closed:   06/01/2010 @ $79.7 (-6.43% in 16 days)
9 pts


Below is a selection of companies with stock prices below $5 per share and upcoming binary events in the form of FDA news / decisions or clinical trial results that are expected by mid-year. A common strategy used by many investors is to buy a basket of several small or micro-cap companies (generally less than $1 billion market cap stocks) with pending binary events approximately 3-6 months ahead of the expected catalyst date and sell into the expected upward momentum in both stock price and trading volume.

<font> Click here for a four-minute video </font> <font> that includes an overview of mikehavRx.com and this binary event investing strategy. Extreme trades such as those profiled below can be viewed as call option trades due to their low stock prices and high risk / reward profile. For this reason, investing in a basket of several low-priced stocks with pending binary events and following the strategy outlined above is an effective way to mitigate the risk of investment losses while participating in the potential run-up in stock price as the catalyst date approaches. </font>

<font> 1.) AspenBio Pharma (NASDAQ:APPY) - $3.36 (last price) - $126 million (market cap) </font>

<font> AppyScore (blood-based diagnostic test appendicitis) </font>

<font> APPY completed patient enrollment for its AppyScore pivotal study in March that is designed to evaluate 800 patients suspected of having acute appendicitis with results to support a potential 510(k) submission expected by the end of 2Q10 (30-June). </font>

<font> 2.) Avanir Pharma (NASDAQ:AVNR) - $2.69 - $224 million </font>

<font> ZENVIA (dextro-methorphan + quinidine) </font>

<font> AVNR is seeking approval of ZENVIA for the treatment of patients with pseudobulbar affect and announced on 30-April that it made a NDA resubmission to FDA with an expected reply by Agency within two weeks to formally accept the filing and issue PDUFA goal action date as either a Class 1 (two-month review) or Class 2 (six-month review) Resubmission. AVNR has provided guidance for Class 2 resubmission status and a six-month review by the FDA and an update is expected soon on the resubmission status. </font>

<font> 3.) Biomoda (OTCBB:BMOD) - $0.162 - $14 million </font>

<font> CyPath (experimental lab-based diagnostic assay screening test for lung cancer) </font>

<font> Biomoda is collecting 44 additional sputum samples required to complete an ongoing Phase 2 study with results expected 2Q10 and is also preparing to conduct a pivotal Phase 3 study (with up to 3500 patients) to support FDA marketing clearance with an expected start by year-end 2010 to support a potential FDA medical device / diagnostic submission by year-end 2011. </font>

<font> 4.) Cyclacel Pharma (NASDAQ:CYCC) - $2.20 - $81 million </font>

<font> Sapacitabine (CYC682) </font>

<font> CYCC expects a reply from the FDA in the near-term for its Special Protocol Assessment (SPA) request for a Phase 3 acute myeloid leukemia (AML) and will also report myelodysplastic syndromes (MDS) interim Phase 2 data at American Society of Clinical Oncology (ASCO) in early June. Sapacitabine is also being evaluated in an ongoing Phase 2 study for non-small cell lung cancer (NSCLC). </font>

<font> 5.) Access Pharma (OTCBB:ACCP) - $2.30 - $31 million </font>

<font> MuGard : Post-Marketing Clinical Trial Data (Europe), North American Market Launch </font>

<font> Will present post-marketing study data from Europe (marketing partner is privately held SpePharm) and will host an oral mucositis (OM) symposium at the MASCC Supportive Cancer Care Conference June 24-26. The North American commercial launch for MuGard is expected to occur by mid-year and the first commercial production run has been completed by the Company’s contract manufacturing partner Accupac. </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 541 entries and 341 companies (including over 150 stocks trading under $5 per share and 14 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: Long ACCP, BMOD </font>



October 22

Expanding Defensive Growth Index into Europe
Mikerun
   Mike Havrilla   10/22/08  

This pick is about: British American Tobacco PLC (BTI)
Rating:   Positive   $48.54 (10/22/08)
Closed:   05/22/2010 @ $57.75 (+18.97% in 576 days)
9 pts


Expanding Defensive Growth Index into Europe


The accompanying table presents an updated version of the ETFI Highly Defensive PerformIdex, which is expanded to 40 companies with market caps of at least $10B from the industry groups listed below. This defensive growth index is heavily weighted in consumer staples and healthcare and is now structured to include companies based in Europe, in addition to the United States and Canada.

Compared to the previous version, this index has a lower beta and higher average market cap and adds European companies such as Nestle (NSRGY), Roche (RHHBY), British American Tobacco (BTI), Unilever (UN), Diageo (DEO), Alcon (ACL), and Tesco (TSCDY). New companies from the U.S. include McDonalds (MCD), Medtronic (MDT), Baxter (BAX), Gilead Sciences (GILD), and Pfizer (PFE).

Health insurance and managed care companies were removed as an industry group from the index in order to focus on drug makers, medical equipment, diagnostics, and biotech. Other adjustments include reducing exposure to aerospace and defense to a single company while adding McDonalds as a trade-down, fast food play during the economic downturn.

(A) Consumer Staple Retailers (3) – Groceries (1), Drugs (1), Mass Merchant Discounters (1)

(B) Consumer Staple Products (13) – Non-Food/Beverage (2), Processed & Packaged Foods (4), Tobacco (2), Alcoholic Beverages (2), Non-Alcoholic Beverages (2), Diversified Products (1)

(C) Telecom Services (3)

(D) At Home Entertainment (3) – Cable Television Providers (1), Internet Portals & Online Advertising (1), Television Programming + Movie Studios (1)

(E) Utilities (3)

(F) Fast Food Restaurants (1)

(G) Commodities (2): Gold Mining (1) + Agricultural Products – Seeds & Fertilizers (1)

(H) Healthcare (11) – Brand Drugs (3), Biotech (3), Medical Equipment + Supplies (3), Generic Drugs (1), Diagnostics (1)

(I) Aerospace & Defense (1)


May 15

Abbott Deal Highlights Growth Prospects for Generic Drugs in Emerging Markets
Mikerun
   Mike Havrilla   05/15/10  

This pick is about: Abbott Laboratories (ABT)
Rating:   Positive   $48.5 (05/15/10)
Closed:   05/22/2010 @ $46.94 (-3.22% in 7 days)
10 pts


Last week, Abbott Labs (NYSE:ABT) <font> announced a collaboration </font> <font> with India-based Zydus Cadila and created a stand-alone established products division that accounts for over $5 billion in sales. ABT licensed 24 pharmaceutical products from Zydus that are focused on 15 high-growth emerging markets and the deal includes an option for over 40 additional products. Financial terms of the deal were not disclosed. </font>

<font> The established products division consists of branded generics, which represent off-patent products subject to generic competition that are able to retain many of the characteristics of proprietary pharmaceutical products - especially in emerging markets - representing significant opportunities for long-term sales growth and profits. The agreement combines Abbott's established infrastructure in emerging markets (which account for approximately 20% of its total pharmaceutical sales) with the products being developed by Zydus for a wide variety of conditions and expected commercial launches in early 2012. </font>

<font> The </font> <font> HavRx Global Generic Drug Index </font> <font> is passively managed and tracks the performance of companies which meet any of the three inclusion criteria outlined below. </font>

<font> 1.) Derive either $500 million (USD) OR more than 50% of trailing 12-month revenue from the manufacture and sale of any type of generic (off-patent) prescription or over-the-counter (OTC) drug product intended for use by humans, including contract manufacturing services, active pharmaceutical ingredient (API) suppliers, and intermediate product suppliers for drug products and biological agents; </font>

<font> 2.) Have one or more compound(s) in active clinical development OR have a pending ANDA with the FDA for a generic drug candidate; or </font>

<font> 3.) Receive FDA approval for an ANDA within the past 12 months. The index excludes all companies that derive over 50% of trailing 12-month revenue from the sale of patent-protected or legacy brand prescription or OTC drug products. </font>

<font> As illustrated in the chart above, the HavRx Global Generic Drug Index has gained over 70% since being tracked at Investars YOU in late June 2009, outpacing the S&P 500 Index by over 2X. In addition, generic drugs have outpaced existing healthcare, pharmaceutical and even biotech exchange-traded funds (ETFs) over the past year, including the PowerShares Dynamic Pharma (PJP) (+30.5%), iShares DJ US Pharma (IHE) (+30.8%), Pharma HOLDRs (PPH) (+7.6%), S&P Pharma SPDR (XPH) (+48.8%), Healthcare Sector SPDR (XLV) (+17.1%), iShares Nasdaq Biotech (IBB) (+29.7%), and SPDR S&P Biotech (XBI) (+19.9%). </font>

<font> Approximately 75% of the companies in the HavRx Global Generic Drug Index are based outside of the U.S. (including many small and mid-cap stocks based in emerging markets such as China and India), which strengthens the case for the development and launch of a Global Generic Drug ETF - which would provide both retail and institutional investors a cost-efficient means to trade this globally diversified, growth industry in a single, cost-effective and convenient investment vehicle. </font>

<font> The strong underlying fundamentals for the global generic drug industry are outlined below. </font>

<font> 1.) approximately 70% of all prescriptions in the U.S. are filled with generic drugs; </font>

<font> 2.) IMS Health estimates $135 billion in branded drug sales (including $90 billion in U.S.) will face generic competition / patent expiration over next five years (including blockbusters such as Lipitor and Plavix); </font>

<font> 3.) IMS Health estimates $42 billion in global generic drug sales in 2011, representing growth from an expected $28 billion in global sales in 2009 and $17 billion in 2008; </font>

<font> 4.) IMS Health estimates that the generic drug industry is growing at 7.8%, which is a faster pace than the worldwide market for pharmaceuticals; and </font>

<font> 5.) the National Association of Chain Drug Stores estimates that in 2007 the average retail price of generic prescription drugs was $34.34 as compared to a much higher (over 3X) average price for brand name drugs at $119.51. </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 544 entries and 343 companies (including over 150 stocks trading under $5 per share and 14 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



August 01

FDA Calendar Extreme Trades: 30 Stocks Under $5
Mikerun
   Mike Havrilla   08/01/09  

This pick is about: Javelin Pharmaceuticals Inc (JAV)
Rating:   Positive   $1.9 (08/01/09)
Closed:   05/20/2010 @ $1.82 (-4.21% in 292 days)
9 pts


Below are extreme trades among 30 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 292 entries as of 8/1/09. 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 BioMedReports.com, 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 clinical trial results.
 
 
A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume.
 
As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports. Keep in mind that 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. <font> Click here for more info </font> at the FDA website regarding the regulatory approval process for medical devices.
 
Ereska is a non-opiate pain drug being developed by (1) Javelin Pharma (AMEX:JAV)($1.90) for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury).
 
On 5/7/09, (2) Avanir Pharma (NASDAQ:AVNR) ($2.15) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine) AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.
 
On 5/11/09, (3) Acadia Pharma (NASDAQ:ACAD) ($4.07) provided the following update along with its quarterly financial results: Enrollment was completed in the Company’s first pivotal Phase 3 trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.
 
On 3/9/09, (4) Angiotech Pharma (NASDAQ:ANPI) ($1.68) presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company's 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study. ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture.
 
On 6/19/09, (5) BioElectronics (BIEL.PK) ($0.056) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.
 
On 7/29/09, BIEL.PK announced that preliminary data on a heel and foot pain study show strong efficacy and 100% safety using the ActiPatch device. The study also showed study participants were able to significantly reduce their use of acetaminophen (Tylenol) and non-steroidal anti-inflammatory drugs (NSAIDs). Clinical studies in the areas of breast augmentation, Cesarean section, Uveitis, and several areas of surgical recovery are quickly coming to a close with data expected over the coming months. With the data provided by the Genecov study, the management team plans to accelerate its FDA 510(k) pre-marketing clearance filing for general musculoskeletal complaints designed to lead to over-the-counter approval. In addition, the Company will soon submit an additional application of 510(k) pre-marketing clearance for general surgical recovery.
 
On 5/15/09, (6) INVO BioScience (IVOB.OB) ($0.10) provided the following update on obtaining FDA marketing clearance for its fertility technology. INVO technology assists infertile couples in having a baby. In-vitro fertilization (IVF) is an effective treatment option for most infertile couples, and the Company’s patented and proven INVOcell technology is a low cost alternative to IVF that is much simpler to perform. INVO uses a device, the INVOcell, which is currently priced at $75-225 to distributors in developing countries and $125-300 in Europe and U.S. While IVOB penetrates the infertility markets in Europe, Canada, and select developing countries, the Company has also completed the first step for medical device companies who manufacture Class 2 devices with the filing of a Premarket Notification 510 (k) submission with the FDA. Technically, the FDA does not “approve” Class 1 and 2 medical devices for sale in the U.S. as the Agency issues “clearance” for them to be sold and marketed. IVOB hopes to receive U.S. marketing clearance by 2010 upon completion of its clinical trial.
 
On 5/12/09, (7) Pharmos (PARS.PK) ($0.40) reported 1Q09 results and announced that it advanced a Phase IIb trial of its lead non-serotonergic compound, dextofisopam, in female irritable bowel syndrome (IBS) patients. The Phase IIb trial was fully enrolled on 4/9/09 at 324 patients. All patients in the trial are expected to complete treatment by mid-2009 and top-line results are expected in early September 2009.
 
On 5/15/09, (8) Novavax (NASDAQ:NVAX) ($4.34) announced that enrollment has been completed in the second Phase II clinical trial of its trivalent virus-like particle (VLP) seasonal influenza vaccine. This Phase IIa randomized, placebo-controlled study is evaluating a VLP vaccine against the H3N2, H1N1, and B influenza strains that circulated in the 2008-2009 influenza season. This clinical trial represents another step in the development of Novavax's VLP seasonal influenza vaccine, allowing further evaluation of safety and immunogenicity of a broad range of vaccine doses against a new set of influenza strains. As announced in December of 2008, the first Phase II study evaluated a trivalent VLP vaccine against the seasonal influenza strains that circulated in the 2005-2006 influenza season.
 
Specifically, this new study is evaluating the safety and immunogenicity of the 2008-2009 influenza vaccine in approximately 220 healthy adults between the ages of 18 and 49 years. Subjects have received a single injection of either a placebo or the VLP vaccine at doses of 15 mcg or 60 mcg per strain. The results of this study will be used to help select a dose for further evaluation in a clinical trial involving adults 65 years of age and older later this year and in a subsequent Phase III efficacy study. The completion of enrollment keeps NVAX on track for reporting top-line data for the 2008-2009 vaccine during 3Q09 and selecting a dose for a Phase II trial in older adults later in 2009.
 
On 7/27/09, (9) Neoprobe (NEOP.OB) ($1.30) announced the Company will receive $3.5 million from a warrant exercise by Montaur Life Sciences with the proceeds being used to complete the development of Lymphoseek and to prepare for the commencement of a new Phase 3 evaluation of the Company’s RIGS technology in colorectal cancer. Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping. A Phase 3 multi-center clinical trial for Lymphoseek in patients with breast cancer or melanoma has been successfully completed and a protocol for a second Phase 3 clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck cancer has been initiated at clinical sites.
 
Neoprobe has successfully completed a Phase 3 evaluation of Lymphoseek in breast cancer and melanoma patients and the warrant exercise affords the resources to complete the Lymphoseek development program and to prepare and submit the regulatory submissions to secure marketing clearances for Lymphoseek from FDA and EMEA. The RIGS system is a proprietary technology that utilizes tumor specific radiolabeled antibodies that localize to disease involved tissue and where the tissue is identified during the course of a patient’s cancer surgery. Neoprobe is initiating manufacturing initiatives for the RIGS technology consistent with the most recent favorable scientific advice assessment received from the EMEA while awaiting a review of the RIGS program by FDA.
 
On 6/1/09, (10) GenVec (NASDAQ:GNVC) ($0.80) announced that overall survival data in locally advanced pancreatic cancer patients treated with TNFerade in GenVec's ongoing Phase 3 Pancreatic Cancer Clinical Trial with TNFerade (PACT) were presented at ASCO. The analysis concluded that TNFerade appeared to be safe and well-tolerated, indicating a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone. In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. GenVec's PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer. The next interim analysis is expected to occur after two-thirds of the events (or 184 deaths) have occurred in the trial. Results are expected to be announced in early 2010.
 
On 6/1/09, (11) Antigenics (NASDAQ:AGEN) ($2.19) announced results of an interim analysis from the Company’s ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010. In October 2008, AGEN submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma. AGEN expects a decision on its European marketing application by late 2009 and the Company has not yet filed for U.S. marketing approval with the FDA.
 
On 6/15/09, (12) Aeterna Zentaris (NASDAQ:AEZS) ($2.62) 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.
 
On 6/17/09, (13) BioSante Pharma (NASDAQ:BPAX) ($1.83) announced that based upon a review of study conduct and blinded data from the LibiGel Phase 3 Cardiovascular and Breast Cancer Safety Study, the LibiGel Safety Study External Executive Committee has recommended continuation of the LibiGel Phase 3 clinical program. A very low cardiovascular event rate has occurred thus far in the clinical trials. The Executive Committee evaluated study information from over 1,000 women enrolled totaling approximately 600 women-years of exposure in the Phase 3 LibiGel safety study. BPAX stated that its objective is to submit a NDA for FDA approval of LibiGel in late 2010 or early 2011 for the proposed treatment of hypoactive sexual desire disorder (HSDD) in menopausal women after the expected completion of the Phase 3 studies by mid-to-late 2010. In addition to the Phase 3 cardiovascular and breast cancer safety study, BPAX is conducting two LibiGel Phase 3 efficacy trials.
 
The Phase 3 efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement). (14) Antares (AMEX:AIS) has a mid-single digit royalty percentage and milestone sharing rights in the U.S. AND exclusive marketing rights in Europe and elsewhere since LibiGel is based on the Company's Advanced Transdermal Delivery (ATD) gel technology.
 
On 7/7/09, (15) CEL-SCI Corp. (AMEX:CVM) ($0.50) provided the following updates in a letter to shareholders. The Company’s three business units include: (1) Vaccines/treatment: H1N1 (swine) and other influenza viruses, as well as a vaccine for rheumatoid arthritis; (2) Late-stage non-toxic cancer immunotherapy, Multikine, designed to make the first cancer treatment more successful; and (3) Unique contract manufacturing services using new manufacturing facility. CVM recently completed its $22 million manufacturing facility, which is expected to be validated within the next 3 months (i.e. early October 2009) for the manufacture of Multikine for the Company’s pending Phase III trial and subsequent sale if approved for marketing.
 
CVM stated that the validation of this facility is a critical step to starting the pivotal Phase 3 trial for Multikine. CVM stated that the Phase 3 study protocol was designed in consultation with the FDA and is expected to enroll about 800 patients to assess overall patient survival as the primary outcome. The Company also stated that the FDA has granted Multikine Orphan Drug status in the USA, and (if the Phase 3 study is successful) Multikine would be on course to become the recommended first-line treatment for head and neck cancer. On 6/30/09, CVM announced that it completed a registered direct offering under which it raised gross proceeds of $5.85 million.
 
On 7/8/09, (16) Transdel Pharma (TDLP.OB) ($1.40) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The multi-center trial is being conducted at about 30 sites in the U.S. and has enrolled over 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
 
On 7/15/09, (17) Health Enhancement Products (HEPI.OB) ($0.44) announced preliminary results of its study to confirm the efficacy of the ProAlgaZyme (PAZ) (a liquid product drawn from living algae grown in purified water) bioactive compound in managing LDL and HDL cholesterol levels. The Company awarded a grant on 3/30/09 to the Department of Nutrition and Food Science of Wayne State University (WSU), which ranks among the nation's top 50 public universities engaged in basic and applied biomedical research by the National Science Foundation. The WSU study confirmed that the PAZ organic compound was found to reduce LDL (bad) cholesterol levels from 131.7mg/dL to 79.57mg/dL and improve HDL (good) cholesterol from 105.27mg/dL to 138.67mg/dL in test animals (hamsters).
 
Upon completion of the study, WSU will publish a scientific paper describing the final results, as well as the means and methods employed, to be authored by the principal investigator, Smiti Gupta, Ph.D., assistant professor of Nutrition and Food Science at WSU. The cholesterol findings are initial results of a larger study, which also includes investigating the effect of PAZ organic compounds on the management of generalized inflammation. Those results are pending and will be released as they are completed by WSU.
 
On 7/20/09, (18) Labopharm (NASDAQ:DDSS) ($1.99) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Gruppo Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market.
 
On 7/29/09, DDSS confirmed that Gruppo Angelini submitted a plan to the FDA addressing issues at a production plant raised in the Agency’s CRL. The next step is for the FDA to accept the resubmission and issue either a Class I (60-day) or Class II (six-month) review period for a decision on the NDA. DDSS will host a conference call on Friday, August 7, 2009 at 8:30 a.m. (ET) to discuss its second quarter 2009 financial results. Labopharm will report its second quarter 2009 financial results via news release at approximately 7:00 a.m. the same day.
 
On 4/14/09, (19) Marshall Edwards (NASDAQ:MSHL) ($0.76) announced that it will be undertaking an un-blinded analysis of the data from its Phase 3 clinical trial known as OVATURE (OVArian TUmor REsponse). On 6/17/09, Independent Data Monitoring Committee (IDMC) created to oversee the conduct of the OVATURE Trial announced that completion of data collection and database lock will likely require a further six months for analysis of the primary efficacy endpoint of Progression Free Survival. Per the study protocol, the secondary endpoint, overall survival, cannot be analyzed until 18 months after the last patient was randomized, or sooner if there are no patients surviving. The Company decided to conduct an un-blinded analysis of the data in order to assess the clinical and commercial opportunities for phenoxodiol and to enable the continuing funding from current resources.
 
Phenoxodiol is being developed by MSHL as a chemo-sensitizing agent in combination with platinum drugs for late-stage, chemo-resistant ovarian cancer and as a mono-therapy for prostate and cervical cancers. MSHL is majority owned (71.3%) by (20) Novogen (NASDAQ: NVGN) ($3.10) , an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. The Company intends to allocate its current funds of approximately $23 million to completing the OVATURE data analysis of 142 patients, pursuing negotiations for out-licensing phenoxodiol should evidence of efficacy and safety emerge from the OVATURE analysis, maintaining other ongoing phenoxodiol ovarian and prostate cancer clinical trials, initiating the triphendiol clinical program, and in-licensing further promising anti-cancer compounds from Novogen.
 
On 7/31/09, (21) Advanced Life Sciences (ADLS.OB) ($0.48) announced that it received a complete response letter (CRL) from the FDA for the Company's New Drug Application (NDA) for Restanza (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). ADLS.OB will continue to pursue approval of Restanza in CAP and believes that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. In parallel, the Company will continue to advance Restanza as a bio-defense agent against anthrax, plague and tularemia.
 
On 6/2/09, the FDA Anti-Infective Drugs Advisory Committee voted that Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP, but voted that Restanza did not demonstrate efficacy in the treatment of CAP. ADLS.OB is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information and expects to start the additional Phase 3 program during 1H10. On 7/31/09, ADLS.OB announced that it expects to report key data from the Company's ongoing pivotal studies in plague and tularemia by the end of 2009. ADLS.OB plans to submit an NDA amendment seeking marketing approval for the bio-defense indications during 1Q10.
 
On 7/30/09, (22) Anadys Pharma (NASDAQ:ANDS) ($2.67) announced finalization of the protocol for the Company's Phase 2 trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the FDA and patient dosing is expected to commence within the next several weeks. In the Phase 2 study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48.
 
The primary endpoint of the study is the proportion of patients with undetectable virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR). Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen receiving placebo at each dose level. Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end 2009 and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.
 
(23) EnteroMedics (NASDAQ:ETRM) ($3.31) is developing implantable systems to treat obesity and other gastrointestinal disorders. VBLOC Therapy intermittently blocks nerve signaling between the brain and stomach over the vagus nerves using high-frequency, low-energy electrical impulses. The vagus nerves are known to control digestive functions including food processing and feelings of hunger and fullness. The effect of VBLOC Therapy has been demonstrated in early clinical trials, where patients reported reduced time to feelings of fullness at meals, as well as reduced feelings of hunger between meals out to six months with resultant reduced calorie intake.
 
Clinical weight loss results reported to date include mean excess weight loss of 28.1% for the first 17 patients to reach 12 months of therapy and 37.6% for the first 9 patients to reach 18 months in a 38 patient feasibility study. The EMPOWER study is a randomized, double-blind, placebo-controlled pivotal clinical trial that reached its target enrollment of 294 patients in September 2008 under an FDA-approved Investigational Device Exemption (IDE) for the clinical trial. ETRM expects to report top-line results from the study during 4Q09, which will be used for a Premarket Approval (PMA) Class III medical device submission to the FDA for marketing clearance and is currently recruiting patients outside of the U.S. for a feasibility study examining the effects of VBLOC Therapy on blood glucose levels in diabetics.
 
On 7/23/09, (24) Columbia Labs (NASDAQ:CBRX) ($1.19) announced that the Company signed an agreement with PharmaBio Development, Inc. under which Columbia can extend its final royalty payment on sales of Striant (testosterone buccal system) from November 2010 to November 2011. The final payment is estimated at approximately $16.4 million. CBRX stated that the deal will allow the Company to focus its energy on the PREGNANT Study, which is a Phase 3 clinical trial of Prochieve 8% for the prevention of preterm birth in women with a short cervix at mid-pregnancy. CBRX expects to complete enrollment by late 2009, report results in mid-2010 and, if the results are positive, obtain FDA approval in mid-2011.
 
On 7/23/09, (25) Aradigm (ARDM.OB) ($0.204) announced it received clearance from the FDA for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The initial clinical protocol under this IND is an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company’s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis (BE). This orphan drug condition is a chronic severe respiratory disease and there is currently no drug specifically approved for its treatment in the U.S. The Phase 2b study will enroll 96 patients and the primary efficacy endpoint will be the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units following once-daily dosing of two different dose levels vs. placebo for a four-week treatment period. Secondary endpoints will include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes will be monitored for safety.
 
(26) Vion Pharma (VION.OB) ($2.20) has a pending NDA for Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) seeking approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA will receive a standard (10-month) review by the FDA with a PDUFA action date of 12/12/09 for a possible FDA decision.
 
On 6/9/09, (27) Santarus (NASDAQ:SNTS) ($3.14) announced that Schering-Plough HealthCare Products, Inc. has submitted its response to the FDA complete response letter (CRL) for an over-the-counter (OTC) Zegerid branded omeprazole + sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell Zegerid in the U.S. OTC heartburn market. The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology. If Schering-Plough receives FDA approval of its NDA for an OTC Zegerid product, SNTS will earn a $20 million regulatory milestone upon approval, a low double-digit royalty on net sales of OTC Zegerid, and may receive up to an additional $37.5 million in sales milestones.
 
On 4/6/09, SNTS filed NDA for a new tablet formulation to add to its ZEGERID family of branded prescription pharmaceutical products with an expected FDA decision during late 4Q09. In connection with the FDA’s acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
 
On 7/1/09, (28) CombinatoRx (NASDAQ:CRXX) ($0.87) and Neuromed Pharma (privately held) announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed’s New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone).
 
On 7/22/09, (29) Hemispherx Biopharma (AMEX:HEB) ($2.13) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.
 
On 7/29/09, (30) Cell Therapeutics (NASDAQ:CTIC) ($1.48) announced that it was notified by the European Medicines Agency (EMEA) that pixantrone is eligible to be submitted for a Marketing Authorization Application (MAA) through the EMEA's centralized procedure. The centralized review process provides for a single coordinated review for approval of pharmaceutical products that is conducted by the EMEA on behalf of all European Union member states. The EMEA also designated pixantrone as a New Active Substance, which would be eligible for a 10-year market exclusivity period in EU member states upon approval. CTIC will request a meeting with the EMEA to discuss the submission of the MAA for pixantrone to treat aggressive non-Hodgkin's lymphoma (NHL) in the EU member states.
 
 On 7/7/09, CTIC announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.
 
On 6/24/09, CTIC announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. The Company is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.
 
Disclosure: No positions


May 08

Personalized Stock Index Investing at Investars YOU
Mikerun
   Mike Havrilla   05/08/10  

This pick is about: iShares Nasdaq Biotechnology Index Fund (IBB)
Rating:   Positive   $82.55 (05/08/10)
Closed:   05/16/2010 @ $85.18 (+3.19% in 8 days)
9 pts


Investars YOU allows users to build the most personalized, stock index-based portfolios (referred to as “YOUs”) possible and is working to partner with as many brokers as possible to provide users with the flexibility to choose how they invest across any of the indexes which are being offered and tracked at the site. Please contact Investars YOU with any questions or to learn more about investing in the HavRx Stock Indexes through partners such as thinkorswim Advisors, which can also be contacted directly at the preceding link.

<font> TD Ameritrade (NASDAQ: AMTD) acquired thinkorswim in June 2009 and is currently in the process of integrating the brokerage and advisor operations, which is in addition to other pending agreements to make the personalized, stock index-based investing service of Investars YOU available on additional online investing platforms. </font>

<font> The updated performance tracking statistics for the 18 HavRx Stock Indexes are included below and these indexes are also available for licensing and development as exchange-traded funds (ETFs). The list below includes the index name, tracking start date, number of stocks per index, last price for each index, and percentage change for each index since inception. </font>

<font> Healthcare Stock Indexes (13) 
   
Regulatory Catalyst 6/21/09 115 $2,028.21 102.8%
Diabetes Care 11/19/09 50 $1,144.01 14.4%
Cosmetic / Restorative Med 6/24/09 78 $1,339.39 33.9%
Life Science Leaders 12/15/09 25 $931.77 -6.8%
Natural Health 12/15/09 53 $1,040.50 4.1%
Immune Therapy / Vaccines 12/15/09 53 $1,209.98 21.0%
Emerging Cancer Dx / Tx 6/21/09 85 $1,949.20 94.9%
Global Generic Drugs 6/24/09 75 $1,605.11 60.5%
Global Health IT 6/24/09 55 $1,318.62 31.9%
Global Hospitals 6/28/09 51 $1,404.47 40.4%
Stem Cells 6/22/09 48 $1,268.14 26.8%
Health Benefit Providers 6/21/09 54 $1,423.08 42.3%
Global Crop Science 12/17/09 48 $933.47 -6.7% </font>

<font> Non-Health Stock Indexes (5) 
   
Global Clean-Tech 6/21/09 58 $1,213.73 21.4%
Global Railroad Industry 6/24/09 46 $1,370.54 37.1%
Global Tobacco Industry 6/21/09 21 $1,460.49 46.0%
Global Trucking / Logistics 6/24/09 47 $1,257.95 25.8%
Global Air Transport 6/24/09 48 $1,907.06 90.7% </font>

<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The actively managed HavRx Regulatory Catalyst Index update report is currently tracking 530 entries and 333 companies (including over 150 stocks trading under $5 per share and 11 private companies). Promo codes (50% discount) are available for college students, investment clubs, and subscribers to my previous FDA Calendar or similar services. </font>

<font> Disclosure: No positions </font>



March 23

HavRx Stock Indexes: Healthcare Continues Uptrend following Reform
Mikerun
   Mike Havrilla   03/23/10  

This pick is about: Teva Pharmaceutical Industries Ltd (TEVA)
Rating:   Positive   $64.54 (03/23/10)
Closed:   05/15/2010 @ $56.8 (-11.99% in 53 days)
9 pts


The healthcare sector continued its uptrend this week following the Obamacare reform plan. Many stocks in the sector are trading at multi-year or all-time highs such as hospital operator Tenet (NYSE:THC), pharmacy benefit manager (PBM) Express Scripts (NASDAQ:ESRX), and generic drug makers Mylan (NYSE:MYL) + Teva Pharma (NASDAQ:TEVA).

<font> The continued uptrend in the healthcare sector and overall market may be more reflective of resolving the health reform issue and since many of the components of the plan do not take effect until 2014 or later; investors may also be anticipating changes occurring before some aspects of the plan ever take effect. In general, the healthcare reform plan is expected to result in more insured Americans so that hospitals would presumably benefit from lower charge-offs that occur from treating uninsured patients. </font>

<font> Also, the outlook for the generic drug industry is robust due to a focus on healthcare cost containment, upcoming patent expirations for mega-blockbuster drugs such as Pfizer's (NYSE:PFE) Lipitor, and an expected increase in prescription drug volumes that favors generics. </font>

<font> HavRx Index Stats as of 23-March 2010  </font>

<font> Index Name, Tracking Start Date, # Stocks, Last Price, % Chg </font>

<font>


Healthcare Stock Indexes (13)   

  
Regulatory Catalyst 6/21/09 98 $1,885.37 88.5%
Diabetes Care 11/19/09 36 $1,181.48 18.1%
Cosmetic / Restorative Medicine 6/24/09 78 $1,370.45 37.0%
Life Science Leaders 12/15/09 25 $1,052.49 5.2%
Natural Health 12/15/09 52 $1,055.84 5.6%
Immune Therapy / Vaccines 12/15/09 50 $1,165.04 16.5%
Emerging Cancer Dx / Tx 6/21/09 72 $1,890.70 89.1%
Global Generic Drugs 6/24/09 73 $1,695.24 69.5%
Global Health IT 6/24/09 55 $1,320.28 32.0%
Global Hospitals 6/28/09 51 $1,417.59 41.8%
Stem Cells 6/22/09 48 $1,282.80 28.3%
Health Benefit Providers 6/21/09 54 $1,540.78 54.1%
Global Crop Science 12/17/09 48 $1,096.89 9.7%


Non-Health Stock Indexes (5)     


Global Clean-Tech 6/21/09 57 $1,317.39 31.7%
Global Railroad Industry 6/24/09 46 $1,359.63 36.0%
Global Tobacco Industry 6/21/09 21 $1,573.83 57.4%
Global Trucking / Logistics 6/24/09 47 $1,294.24 29.4%
Global Air Transport 6/24/09 49 $1,943.58 94.4%

 

mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed HavRx Regulatory Catalyst Index. Please visit www.mikehavRx.com for more details on my new publishing company, website, and premium service.

Disclosure: No positions

</font>


 
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Investment Style:
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Avg exp holding time:
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Age:
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