Amylin, Alkermes Shares Plunge On Possible FDA Delays

Xconomy San Diego — 

San Diego-based Amylin Pharmaceuticals and its partner, Cambridge, MA-based Alkermes, both took a dive in the stock market today after they said they might face regulatory delays in developing a new diabetes drug. The companies said the FDA might ask them to run another clinical study before they can receive approval of a once-weekly form of the diabetes drug exenatide.

Amylin (NASDAQ: AMLN) fell 21 percent to $8.46 at 1:30 pm Eastern time, while Alkermes (NASDAQ: ALKS) dropped 9 percent to $9.21. Amylin has been in talks with the FDA about what it needs to do to demonstrate that the once-weekly exenatide used in clinical trials is equivalent to the drug it plans to manufacture at large scale in an Ohio factory.

Investors reacted to this line disclosed in a regulatory filing by Alkermes with the Securities and Exchange Commission: “Amylin has recently received feedback from the FDA that these data have not met their requirements to demonstrate comparability.” Amylin said it still hopes to submit its new drug application by the end of the first half of 2009 for the more convenient form of exenatide, currently marketed as a twice-daily injection called Byetta. If the FDA demands a new study, that application will be delayed, Amylin said.