Bloomberg News

Amylin Gains After Diabetes Drug Wins Approval for New Use

October 20, 2011

(Updates with close of trading in second paragraph.)

Oct. 20 (Bloomberg) -- Amylin Pharmaceuticals Inc. rose the most in more than six months after its Byetta drug developed with Eli Lilly & Co. won expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes.

Amylin gained 13 percent to $11.55 at 4 p.m., its biggest climb since April 15. The Food and Drug Administration cleared the injectable medicine, first approved in April 2005, to be used by patients taking insulin glargine, a long-acting insulin marketed by French drugmaker Sanofi as Lantus, Amylin and Lilly said yesterday in a statement.

The move would “make Byetta available to millions of insulin-using Type 2 diabetes patients in the United States,” Vincent Mihalik, senior vice president of sales and marketing at Amylin, said in an April earnings call.

Almost 26 million people ages 20 or older in the U.S. have diabetes, according to the American Diabetes Association in Alexandria, Virginia. At least 90 percent of those have Type 2, the most common form of the disease during which the body doesn’t produce enough insulin or cells ignore insulin. Most Type 2 patients need at least one insulin shot daily.

“This expanded use for Byetta is important for clinical care, in that it provides a new option for the many patients with Type 2 diabetes who are not achieving treatment goals,” John Buse, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill, said in the statement released by the companies.

Drug Sales

Byetta stimulates pancreas cells to produce insulin when blood sugar is high. It has been approved for patients taking other diabetes medicines and on its own as a therapy with diet and exercise.

The drug brought in $559 million for San Diego-based Amylin last year, almost 85 percent of the company’s revenue, according to data Bloomberg compiled. The drug accounted for $151 million in sales for Indianapolis-based Lilly last year.

Sanofi said last week it expects Lantus to generate 2011 sales of 4 billion euros ($5.48 billion.)

Amylin sued Lilly in federal court alleging anticompetitive activity and breach of a strategic alliance agreement, the company said in a statement in May. Amylin wants to stop Lilly from using the same sales force to promote linagliptin, a product Lilly is developing with German drugmaker Boehringer Ingelheim GmbH to complete with Byetta and a once-weekly version called Bydureon under review by the FDA.

Linagliptin, sold under the name Tradjenta, was approved in May by the FDA for sale in the U.S.

--Editors: Andrew Pollack, Steve Walsh

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.


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