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Lilly diabetes drug wins approval for expanded use

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Eli Lilly and Co. and Amylin Pharmaceuticals Inc.’s Byetta has received expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes.

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 Wednesday in a prepared 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, Va. At least 90 percent of those have Type 2, the most common form of the disease in which the body doesn’t produce enough insulin or the cells ignore the 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.

Byetta stimulates the 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 compiled by Bloomberg. 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 $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.


 

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  1. John, unfortunately CTRWD wants to put the tank(s) right next to a nature preserve and at the southern entrance to Carmel off of Keystone. Not exactly the kind of message you want to send to residents and visitors (come see our tanks as you enter our city and we build stuff in nature preserves...

  2. 85 feet for an ambitious project? I could shoot ej*culate farther than that.

  3. I tried, can't take it anymore. Untill Katz is replaced I can't listen anymore.

  4. Perhaps, but they've had a very active program to reduce rainwater/sump pump inflows for a number of years. But you are correct that controlling these peak flows will require spending more money - surge tanks, lines or removing storm water inflow at the source.

  5. All sewage goes to the Carmel treatment plant on the White River at 96th St. Rainfall should not affect sewage flows, but somehow it does - and the increased rate is more than the plant can handle a few times each year. One big source is typically homeowners who have their sump pumps connect into the sanitary sewer line rather than to the storm sewer line or yard. So we (Carmel and Clay Twp) need someway to hold the excess flow for a few days until the plant can process this material. Carmel wants the surge tank located at the treatment plant but than means an expensive underground line has to be installed through residential areas while CTRWD wants the surge tank located further 'upstream' from the treatment plant which costs less. Either solution works from an environmental control perspective. The less expensive solution means some people would likely have an unsightly tank near them. Carmel wants the more expensive solution - surprise!

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