FDA Hurdle for Byetta Sinks Amylin, Alkermes
(Editor's note: For more, check out an upated version of this news story.)
Shares of
Amylin Pharmaceuticals
(AMLN)
plummeted Tuesday after its partner
Alkermes
(ALKS) - Get Alkermes plc Report
disclosed in a filing with the
TheStreet Recommends
Securities and Exchange Commission
the likelihood of regulatory delays for Byetta LAR.
Shares of Amylin were giving up 24% to $8.09 in recent trading Tuesday morning, while Alkermes was shedding 17.8% to $8.30.
Alkermes said it recently received feedback from the Food and Drug Administration that data submitted as part of its new-drug application (NDA) for a long-acting version of diabetes drug Byetta do not meet FDA requirements.
The data are from "correlation studies" that Amylin submitted to show that the drug manufactured by Alkermes in its facility and used in clinical trials was the same as that manufactured on a commercial scale in Amylin's facilty.
According to the filing, Amylin is in active discussions with the U.S. regulatory agency regarding the options to allow the application to be filed 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," Alkermes stated in the SEC filing.
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