European regulators granted marketing approval for an injectable
once-weekly diabetes drug, Bydureon, being developed by Eli Lilly
& Co. (LLY), Amylin Pharmaceuticals Inc. (AMLN) and Alkermes
Inc. (ALKS).
The approval is a positive development for the companies, which
are still hoping to get approval in the U.S. after a rejection of
the drug last year.
Bydureon is a long-acting version of Byetta, a twice daily drug
from Lilly and Amylin that was approved in 2005.
The FDA declined to approve Bydureon early last year and made
the same move in October, requesting more clinical data. The
companies expect to submit that data and re-apply for approval in
the second half of the year.
Bydureon's success is key to the future of Amylin, which hasn't
reported a profit since going public in 1992. The drug also would
be a positive development for Lilly, which is seeking new drugs to
offset looming generic competition to its top products.
Shares of Lilly and Alkermes closed Monday at $37.56 and $17.04,
respectively. Amylin shares closed at $11.42. None of the stocks
were active premarket.
-Thomas Gryta of Dow Jones Newswires contributed to this
article.
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