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Amylin Faces Oct. 22 FDA Review For Bydureon drug

From Associated Press (May 6, 2010)

NEW YORK -- Amylin Pharmaceuticals Inc. and its partners said Thursday the Food and Drug Administration will take until Oct. 22 to make a regulatory decision on the potential diabetes drug Bydureon.

The companies, which include Eli Lilly & Co. and Alkermes Inc., responded last month to an FDA request for more information on manufacturing and a risk mitigation plan. The agency asked for the additional information in March.

Bydureon, or exenatide-LAR, is a once-weekly version of the injectable treatment Byetta, which is currently taken twice daily. It is part of the broader GLP-1 class of drugs, which work by increasing the body’s insulin production.

The FDA approved Novo Nordisk’s once-daily GLP-1 drug Victoza in January. That drug had been under review for two years as safety concerns slowed down the regulatory process. The FDA approved it with a warning over the risk of thyroid cancer.

With competition in the diabetes treatment field tight, the announcement of the October review date sent shares of both Amylin and Alkermes lower in morning trading Thursday.

Shares of Amylin, based in San Diego, fell $1.79, or 9.1 percent, to $17.94. The stock has traded between $10.10 and $24.20 over the last 52 weeks.

Meanwhile, shares of Alkermes, based in Waltham, Mass., fell 76 cents, or 6 percent, to $11.90. The stock has traded between $7.54 and $14.19 over the last 52 weeks.

Shares of Eli Lilly, based in Indianapolis, fell 8 cents to $35.


Posted: May 2010