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Amylin, Eli Lilly Announce Expanded Approval For Byetta In Europe - Update

Eli Lilly and Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN) said Friday that the European Commission has granted an expanded marketing approval for their diabetes drug Byetta.

According to the companies, the EC has additionally approved Byetta as an adjunctive therapy to basal insulin, with or without metformin and/or Actos, for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

"The marketing authorization for the use of Byetta with basal insulin provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said Christian Weyer, senior vice president, research and development, Amylin Pharmaceuticals.

"In a clinical trial, patients using fixed-dose Byetta with titrated basal insulin achieved better postprandial and overall glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using titrated basal insulin without Byetta," said Weyer.

The main study included in the EU marketing authorization submission package was a double-blind, 30-week clinical trial.

In the study, Byetta 10 micrograms or placebo was added to existing insulin glargine therapy (with or without metformin, pioglitazone or both), which was titrated to achieve target fasting glucose levels. The primary endpoint was reduction in A1C, a measure of average blood sugar over three months.

After 30 weeks of treatment, Byetta showed a statistically significant reduction in A1C compared to placebo, lowering A1C by 1.7 percentage points from a baseline of 8.3 percent. Patients treated with optimized insulin glargine plus placebo experienced a 1.0 percentage point decrease in A1C from a baseline of 8.5 percent.

Byetta (exenatide) is an injectable prescription medicine that may improve blood sugar control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. It can also be used with metformin, a sulfonylurea, a thiazolidinedione or Lantus (insulin glargine), which is a long-acting insulin. It was first approved in Europe in 2006.

Byetta was the first glucagon-like peptide-1 receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. Byetta has been available in the U.S. since 2005 and is used in nearly 80 countries worldwide.

Last October, the FDA approved Byetta as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione, along with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

Diabetes affects an estimated 347 million adults worldwide and nearly 26 million people in the U.S. About 90 to 95 percent of those affected have type 2 diabetes.

Lilly and Amylin last November amicably terminated their decade-long collaboration. As part of the transition plan outside the U.S., Amylin will assume responsibility for exenatide product commercialization efforts on a market-by-market basis by the end of 2013.

Amylin will work with Lilly on plans for markets outside the U.S. during the transition period. Both companies are committed to ensuring a seamless transition of global product responsibility to Amylin while maintaining continuity of patient care.

LLY is trading at $39.90, up $0.09 or 0.23%, on a volume of about 1.3 million shares on the NYSE.

AMLN is trading at $15.62, up $0.21 or 1.36%, on about 1.0 million shares on the Nasdaq.

by RTT Staff Writer

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