Recently, Alkermes Inc. (ALKS) announced that its drug Vivitrol, which is indicated for the treatment of alcohol dependence, also helped opioid addicts stay away from drugs. Data from the six-month late-stage trial (n=250) demonstrated that subjects injected with Vivitrol (naltrexone for extended-release injectable suspension) once a month were more likely to pass a urine test compared to recipients of a placebo injection. Furthermore, subjects reported a lower craving for drugs, and half the subjects came clean in at least 90% of their drug tests.   The subjects were addicted to opioid drugs including heroin. Before enrolling for the trial, they had to stay away from drugs for at least a week. The most common adverse event affecting patients during the study were inflammation of the nose and throat in addition to insomnia.   The positive results have formed the basis of Alkermes’ decision to file a supplemental new ...

FDA Issues Complete Response Letter on Intermezzo On October 28, 2009, the U.S. FDA issued a complete response letter (CRL) on Transcept's (TSPT) new drug application (NDA) for Intermezzo. The news has sent the shares down roughly 45%. TSPT is down now over 60% from the high following the stock’s 14% decline yesterday before the news was public (an obvious leak at the FDA). The Good The FDA stated that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo in the as-needed treatment of insomnia characterized by difficulty returning to sleep after awakening in the middle of the night (MOTN).  The FDA also recognized that the Intermezzo data did not indicate significant next-day residual effects. The Bad The FDA requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present ...

Puramed Bioscience Inc. is currently trading at $1.50 per share, up $0.50 or 50%, on volume of about 50,000 shares. The stock, which hit a high of $1.99 earlier today, was mentioned about six months ago – April 2, 2009 – to be exact in the FREE Daily Newsletter from QualityStocks. At the time, Puramed Bioscience’s stock was trading for only 8 cents a share! For investors who jumped aboard at that time, they have seen their holding multiply by nearly 19 times!

Puramed Bioscience engages in the research, development and marketing of non-prescription products. The company’s leading product is LipiGesic M, which provides acute relief from migraine headaches. In addition, Puramed also has plans to launch LipiGesic PM, which provides a remedy for insomnia and other sleep disorders as well as LipiGesic H for common tension headaches.

If you are an investor interested in micro-cap and small-cap stocks, such as Puramed

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Alexza Pharmaceuticals, Inc. announced a private placement equity offering of 8.1 million shares of common stock to several qualified institutional investors. The company will receive $2.4325 per share, or approximately $19.1 million in net proceeds.

Alexza Pharmaceuticals also issued 7.3 million warrants as part of the deal. The warrants entitle the holder to purchase 0.9 shares of common stock at $2.77 per share. The warrants expire in seven years.

Alexza Pharmaceuticals is developing a proprietary drug delivery technology called the Staccato® system. This technology vaporizes unformulated pharmaceutical drugs into an aerosol form that allows rapid systemic delivery through lung inhalation.

Alexza Pharmaceuticals has completed Phase 3 trials for using this technology to deliver Loxapine for use in treating schizophrenic or bipolar disorder patients. The company plans a new drug application submission in 2010.

Staccato® is also being tested for use in other areas, including the treatment

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Results from Arena’s (ARNA) phase III BLOSSOM study are strikingly similar to the BLOOM study, with mean total weight loss for the 10mg lorcaserin BID group coming in at 17.0 lbs in BLOSSOM vs. 17.9 lbs in BLOOM. These equated to 7.9% and 8.2% mean absolute weight loss. The placebo was 3.9% and 3.4% in each trial, respectively, putting the mean placebo-adjusted weight loss for each trial at 4.0% and 4.8%. Total categorical weight loss for the completer analysis was 63.2% in BLOSSOM and 66.4% in BLOOM, vs. 34.9% and 32.1% for the placebo. Per the FDA draft guidance: “A product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose ...

Dr Stock Pick HOT News & Alerts!

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FREE Daily Stock Alerts From DrStockPick.com

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DrStockPick.com Watch List!

My Picks for Wednesday September 16, 2009, are:

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MVIS, Microvision, Inc.

MVIS is a global leader in innovative ultra-miniature projection display and image capture products for mobility applications

Today was the commercial introduction of the world’s first laser-based pico projector, called SHOW WX™, based on its proprietary PicoP® display engine technology.

The MVIS pico projector uses the revolutionary laser-based PicoP display engine that delivers large, colorful, bright, and vivid images that are always in focus, regardless of projection distance. The accessory product is a simple plug-n-play pico projector for people on-the-go who

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Green Planet Bioengineering CO. LTD., a subsidiary of ONE Holdings Corp. (ONEZ.OB), focuses on research and development, production and sale of various extracts that can be used for health supplements and organic agricultural products. The company today issued a press release introducing two natural extracts, Resveratrol and 5-HTP, which are expected to generate about $1.8 million in revenue for the company in the third quarter.

Green Planet has teamed with Fujian Traditional Chinese Medical College to create and execute a marketing campaign for Resveratrol and 5-HTP. The new health supplements have contributed $1 million in revenue since they were originally launched, and Green Planet said it has already secured long-term purchase agreements with two new customers.

“We are very excited to have launched our marketing efforts for these new extracts. Sales appear to show a raising trend, leading us to believe that these two new supplements will be highly

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Working in the big leagues of the pharma world allows little room for error. Make a misstep and quite a bit of capital can be lost. Get the process right, however, and quite a bit of profit can be made. Starting out as a development stage company, in this regard, is never easy but if that first product can get to market, profit will flow for the investor that sticks with it from the beginning.

Somaxon Pharmaceuticals inc., a development stage biotechnology company, works to develop specialty pharmaceutical products directed at disease and psychological issues. It is, for the most part, an in-licensing company and is currently completing Phase III trials for an insomnia product.

Although the company has completed much of its Phase III testing for Silenor, its insomnia product, the FDA has been asking for additional efficacy information regarding elderly patients. The FDA, however, indicated to the company that it

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For Immediate Release

Chicago, IL – August 25, 2009 – Zacks Equity Research highlights Transcept Pharmaceuticals (TSPT) as the Bull of the Day and Nabors Industries (NBR) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Guaranty Financial Group Inc. (GFG), Banco Bilbao Vizcaya Argentaria (BBVA) and BB&T Corporation (BBT).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676

Here is a synopsis of all five stocks:

Bull of the Day:

We recently initiated coverage of Transcept Pharmaceuticals (TSPT) with an Outperform rating and $12 price target. We think Intermezzo is a product that can fill a much needed void for insomnia patients with chronic nocturnal awakenings.

An FDA decision on the pending new drug application is expected in late October 2009. We think approval is a high likelihood event at that time.

With the commercialization

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We are initiating coverage of Transcept Pharmaceuticals (TSPT) with an ‘Outperform’ rating and a $12 price target. Among the key points to our investment thesis are as follows: Intermezzo approval in late October 2009 is a high probability event. We base this optimism on the fact that the company is utilizing the 505(b)(2) pathway for approval of a new low-dose formulation of zolpidem, a molecule that has been already approved by the FDA and is available generic. Since the original approval of zolpidem as Ambien in 1994, the U.S. FDA has since reviewed the molecule multiple times, including three recent formulation approvals of a controlled release tablet with Ambien CR in September 2005, an oral spray with ZolpiMist in December 2008 and a sublingual tablet with Edluar in May 2009. Intermezzo, a sublingual low-dose (3.5mg) formulation of zolpidem will be specifically intended for the use as-needed ...