Biotech Clinical Trials Update: Sanofi, Sunshine Biopharma, Forest Labs

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Includes: FRX, SBFM, SNY
by: Roger Newman

This is one of a series of articles that will highlight recent clinical tria updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.

Sanofi (NYSE:SNY) and its subsidiary Genzyme reported positive top-line results for a Phase 3 trial comparing their compound alemtuzumab to the approved multiple sclerosis treatment Rebif. Genzyme is developing alemtuzumab in conjunction with Bayer HealthCare. Rebif sales reached nearly 1.7 billion Euro in 2010. Trial results showed that alemtuzumab treatment resulted in a 55 percent reduction in relapse rate as compared to Rebif, a significant reduction. Another Phase 3 trial of alemtuzumab is underway with top-line results expected in late 2011. Sanofi expects to file for US and EU approval in early 2012, having been granted fast track status by the FDA.

Sunshine Biopharma Inc. (OTCPK:SBFM) announced that it had completed a study of its compound Adva-27a in Multidrug Resistant Breast Cancer (MRBC) cells. These cytotoxicity studies evaluate the ability of a compound to destroy cancer cells in vitro. Adva-27a was found to be 16 times more effective at killing MRBC cells than Etoposide, a commonly used drug according to the company. SBFM is a small ($21MM market cap) company focused on the treatment of cancer. There is no reported short interest outstanding.

Forest Laboratories, Inc. (NYSE:FRX) announced top-line results from a Phase 3 study of levomilnacipran for the treatment of adults in major depressive disorder. Data showed a statistically significant improvement for those patients treated with levomilnacipran as compared to placebo. Results from two additional placebo controlled studies are expected in late 2011 and the first half of 2012. Major depressive disorder affects approximately 10 million adults in the US each year and annual sales of anti-depressants are in excess of $10 billion per year.

These clinical updates are short summaries and should be used as a basis for further research. You should always perform your own due diligence. Many factors can determine whether a particular drug candidate will ever come to market or be profitable and biotech investing should be considered high risk.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.