The Food and Drug Administration sure gave Amylin Pharmaceuticals
The companies announced bad news yesterday. The FDA wouldn't let Amylin use its in vitro-in vivo correlation studies to prove that the extended-release Byetta manufactured on a commercial scale at its new plant using Alkermes' technology is the same as the drug manufactured on a smaller scale that was used in clinical trials.
The companies, along with marketing partner Eli Lilly
The other possibility, a new bridge trial, could result in the company not being able to file a new drug application by its goal of the middle of next year. A delay would be a huge benefit to Novo Nordisk
The companies and investors knew a delay was possible -- the FDA is giving Genzyme
Amylin may be knocked down, but this is only round one of a three round fight. Don't give up on "the kid" yet.
Are Amylin and Alkermes bad-news buys? Let us know what you think in Motley Fool CAPS. Make an out- or underperform call on these companies; post a pitch about when you think extended-release Byetta will make it to market. It's free. It's fun. And, it's Foolish.
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Novo Nordisk is a Motley Fool Global Gains recommendation. Eli Lilly is an Income Investor selection. The Fool has a disclosure policy.