CORRECT: Lilly, Amylin, Alkermes Diabetes Treatment Misses Primary Endpoints

Date : 03/03/2011 @ 10:25AM
Source : Dow Jones News
Stock : Alkermes Plc - Ordinary Shares (ALKS)
Quote : 56.12  -0.85 (-1.49%) @ 5:45PM

CORRECT: Lilly, Amylin, Alkermes Diabetes Treatment Misses Primary Endpoints

Lilly Eli (NYSE:LLY)
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("Lilly, Amylin, Alkermes Diabetes Treatment Misses Primary Endpoints," at 8:31 a.m. EST, misstated that Bydureon was approved in 2005 in the sixth paragraph. The correct version follows: )


An investigational drug to treat Type 2 diabetes under development by Eli Lilly & Co. (LLY), Amylin Pharmaceuticals Inc. (AMLN) and Alkermes Inc. (ALKS) failed to meet primary endpoints in a 26-week study.

Lilly shares were down 33 cents at $33.95 in recent premarket trading, while Alkermes and Amylin were halted ahead of the announcement. They closed Wednesday at $14.10 and $15.01, respectively.

The treatment, Bydureon, was less effective in reducing blood sugar levels than Victoza, an injectible diabetes treatment made by Novo Nordisk A/S (NVO, NOVO-B.KO). However, Victoza patients reported more frequent adverse reactions.

The Food and Drug Administration had requested further data on Bydureon during October. The companies plan to submit a complete response in the second half of this year.

Lilly's outlook has been shaky because it faces a wave of patent expirations that will expose its best-selling drugs to generic competition in coming years. Compounding its challenges, Lilly has suffered a series of research and regulatory setbacks that have hampered efforts to bring new products to market to replace the lost revenue.

Bydureon is a long-acting version of already-approved diabetes drug Byetta, which has been available in the U.S. since June 2005.

"While this study did not meet its primary endpoint, these results reinforce the important role" of the drug class in treating Type 2 diabetes, said Gwen Krivi, vice president product development at Lilly's diabetes unit.

Evaluation of the data continue, and the companies plan to submit a full study for publication.

-By Tess Stynes, Dow Jones Newswires; 212-416-2481;


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