Amylin Pharma (AMLN) Sees Morning Pressure

November 4, 2008 9:51 AM EST

After trading higher earlier, Amylin Pharmaceuticals Inc. (Nasdaq: AMLN) has fallen sharply over the past few minutes. The stock is now down 30%.

There was an 8-k filing from Alkermes (Nasdaq: ALKS) mentioning Amylin:

"Alkermes, Inc. is working with Amylin Pharmaceuticals, Inc., or Amylin, to develop exenatide once weekly, a long-acting formulation of exenatide. Amylin submitted data from its in vitro in vivo correlation studies to the U.S. Food and Drug Administration, or FDA, to demonstrate comparability between exenatide once weekly manufactured by Alkermes in its facility and used in previous clinical studies and exenatide once weekly manufactured on a commercial scale in Amylin’s Ohio facility. Amylin has recently received feedback from the FDA that such data have not met FDA requirements to demonstrate comparability. Amylin is in active discussions with the FDA regarding options to enable a New Drug Application, or NDA, submission by the end of the first half of 2009. If Amylin is required to initiate a new clinical study, the timing of the NDA submission would depend on the parameters of the new study, and the submission could be delayed beyond the previously stated filing timeline of by the end of the first half of 2009."

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