This is one of a continuous series of articles that will highlight recent clinical trial updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.
Alkermes Inc. (ALKS) announced topline results from a Phase 2 trial of ALKS 33 for binge eating disorder. ALKS 33 demonstrated a significant reduction in reported binge eating episodes but these results were not markedly different from the placebo. ALKS announced that it will not move forward with further studies for this indication. ALKS 33 does remain in development for other indications such as alcohol dependence and in combination with ALKS 5461 for cocaine addiction and treatment-resistant depression. ALKS has a market cap of $1.8 billion and latest 12 month sales of $186 million (click here). Just over 700,000 shares of ALKS are sold short, or about 7 days to cover (click here).
Amylin Pharmaceuticals (AMLN) reported that exenatide in a once-weekly formulation (Bydureon) did not appear to cause an irregular heart rhythm. This was in response to an FDA request for additional information. ALKS owns the technology that allows the compound to last long enough in the blood to allow once-weekly injections. If successful, Bydureon would replace a twice-daily shot with a once-weekly injection, a significant quality of life improvement. According to statistics, 25 million in the U.S. suffer from diabetes, a number that is expected to rise due to the national problem of obesity. Bydureon was approved for sale in Europe last month (click here). Eli Lilly (LLY) is also partnered with AMLN on Bydureon.
Titan Pharmaceuticals Inc. (OTCQB:TTNP) announced positive results from its Phase 3 trial of Probuphine in treating patients with opiod dependence. Probuphine is a subcutaneous implant that delivers a steady dose of the drug buprenorphine (click here) over six months following implantation. This helps to ensure compliance with treatment prescribed as opposed to the typical sublingual administration of buprenorphine which requires voluntary compliance. TTNP is a small ($104 million market cap) company focused on discovery of products for the treatment of central nervous systems diseases. TTNP has only 59 million shares outstanding and no meaningful short interest. It is traded on the over the counter bulletin board system.
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 very high risk.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.