Amylin Pharmaceuticals, Inc., (NASDAQ: AMLN) has been a battered biotech lately. But shares have just now gotten back above the single-digit threshold and are up more than 80% from recent lows. This morning Amylin and partner Eli Lilly & Co. (NYSE: LLY) announced that the US FDA feedback on the DURATION-1 study is appropriate to use as the basis for demonstrating comparability between intermediate-scale clinical trial material made in Alkermes’ (NASDAQ: ALKS) manufacturing facility, and commercial-scale drug product made at Amylin’s manufacturing facility.
The company said that this provides the companies with an appropriatepathway to demonstrate manufacturing comparability of exenatide onceweekly. The companies are also now confident of the new drugapplication being filed by the end of the first half of 2009.
The overall DURATION clinical program was designed to demonstratesuperiority of exenatide once weekly in comparison to other medicationsin the treatment of type 2 diabetes. The study remains on track. Thesecompanies recently initiated DURATION-4 as the fourth planned DURATIONstudy to examine exenatide once weekly as a monotherapy treatmentcompared to either metformin, a thiazolidinedione or a dipeptidylpeptidase-4 inhibitor. The double-blind study is expected to includeapproximately 800 patients and be completed in 2010.
Amylin may finally get back on track here as a stock. That doesn’t mean that it will fire off to the moon, but it islikely that this will at least stabilize what was feeling like anendless fall in the share price. A once per week treatment for diabetics would be a sharp improvement from the regimens of today.
Amylin Pharmaceuticals (AMLN) is up over 19% at $10.20 and its 52-weektrading range is $5.50 to $39.33. Alkermes (ALKS) is up 4% at $9.06,and its 52-week trading range is $5.55 to $17.05.
Eli Lilly (LLY) also gave better-than-expected guidance for 2009. This was onslower revenue expectations, but it appears good enough for today’smarket. Eli Lilly shares are up 1.7% at $35.65.
Jon C. Ogg
December 11, 2008