Amylin Shares Soar as Diabetes Drug Catches a Break From FDA

Amylin Pharmaceuticals stock shot up this morning after the company said it had some good fortune in dealings with the FDA. The San Diego biotech said it will be able file an application to market its diabetes drug, the once-weekly version of exenatide, in the first half of 2009 after all. That’s despite a warning the company issued last month that said it might take a lot longer.

Amylin (NASDAQ: AMLN) shares climbed 26 percent to $10.75 at 10:17 am Eastern time after the news was released. Amylin’s technology partner, Cambridge, MA-based Alkermes, got a milder boost, rising 4.4 percent to $9.08.

The FDA came around to Amylin’s idea that an extension study of a trial called Duration-1 would offer enough proof to show that the version of once-weekly exenatide used in clinical trials is equivalent to the stuff it plans to make in a large-scale commercial plant in Ohio. This is critical for Amylin, which is counting on the once-weekly exenatide to drive much of its future growth. The current version of exenatide (Byetta) is Amylin’s biggest moneymaker, generating $636 million in sales in 2007 for Amylin and its marketing partner, Eli Lilly. Even so, it can be a drag for patients because it must be taken in twice-daily injections. And more recently, demand has been dropping because since the FDA warned physicians about cases of pancreatitis that occurred in patients taking the medicine.

The once-weekly exenatide uses polymer technology to help make the drug last longer in the body, requiring fewer injections. That should make patients more willing to keep them taking the drug to control their blood sugar.

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