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European committee endorses Bydureon for approval

Fri, 04/15/2011 - 7:17am
The Associated Press

Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Friday a European committee has endorsed its potential diabetes treatment Bydureon, a key step toward possible approval in the European Union.

Bydureon is a once-weekly, injectable version of the type 2 diabetes treatment Byetta, which was developed San Diego-based Amylin and licensed to Indianapolis-based Lilly.

The companies said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval. The European Commission, which approves medicines for the European Union, usually makes a decision on these recommendations in two or three months.

Alkermes Inc. of Waltham, Mass., also is involved in developing the longer-lasting versions of Byetta, which is injected twice a day.

Shares of Amylin jumped 13.6 percent, or $1.54, to $12.80 at the start of trading Friday, while Alkermes climbed 3.3 percent, or 44 cents, to $13.85 and Lilly rose 24 cents to $35.99.

Analysts see Bydureon as an important potential revenue source for Amylin, which has one other drug on the market aside from Byetta. Lilly, meanwhile, has a portfolio that includes eight drugs that passed $1 billion in sales last year.

The companies said last month that Bydureon proved inferior to a daily version Novo Nordisk's Victoza, according to initial results from a late-stage study comparing the drugs.

In the United States, the Food and Drug Administration declined to approve Bydureon in October and asked the companies for more data about the drug. The companies plan to respond in the second half of this year.

The companies also are developing a monthly version of Bydureon, and they said in March that it did well in a small, mid-stage study measuring effectiveness, safety and tolerability.

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