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Byetta Shares Dropping Upon News Of Four More Deaths

Posted by Jane Akre
Wednesday, August 27, 2008 1:49 PM EST
Category: Major Medical
Tags: Byetta, Amylin Pharmaceuticals, Eli Lilly, Type 2 Diabetes, FDA and Prescription Drugs

More bad news about Byetta and pancreatitis deaths. 

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IMAGE SOURCE: Amylin Pharmaceuticals, Web site

 

Lilly and Amylin Pharmaceuticals now say there have been four more deaths associated with their drug for type-2 diabetes, Byetta.

Marketwatch is reporting that Amylin Pharmaceutical shares plunged more than 24 percent by midday, the lowest level in eight years.

Marketing partner Eli Lilly fared a little better, down only one percent.

After the market closed Tuesday the two companies held a conference with analysts to discuss two deaths from complications from pancreatitis, a severe inflammation of the pancreas.

It was then that the company executives disclosed that four more suspected deaths have also been reported among Byetta users.  The patients all had pancreatitis at some point, but none died directly from it.

Pancreatitis, can result in toxins being released into the bloodstream, but it rarely leads to death and usually takes a week to subside.

The company said it was reporting the additional deaths “in the interests of transparency.”

Analysts are downgrading shares of Amylin to sell from hold citing “heightened vigilance for patient safety”.

Doctors were advised by the FDA not to use Byetta in patients with symptoms of the disease.

Amylin executives say the four cases did not involve patients with necrotizing form of pancreatitis which affects about 20 percent of patients with an inflammation of the pancreas. In the necrotizing form of pancreatitis, enzymes digest the pancreas, which can lead to a hemorrhage.

“It appears the FDA focused on necrotizing and hemorrhagic pancreatitis, whereas these other four cases only had pancreatitis in their history,” Orville Kolterman, Amylin’s senior vice president of research and development, tells Reuters.

The Food and Drug Administration is considering adding a black box warning to the drug. Last October, a warning label was updated to include the risk of pancreatitis.

Byetta, also known as exenatide, and approved in June 2005, is part of a new class of diabetes drugs, GLP-1 analogues.

It is delivered twice a day by injection and it is supposed to lower blood sugar in patients with type 2 diabetes and aid in weight loss. The effort it takes to receive two injections a day may be partially responsible for a drop-off in sales in recent months.

Amylin is still planning to introduce a longer-acting delayed release form of Byetta taken once-a-week. The companies planned to file for approval in 2009.

About one million people have taken Byetta which produced sales of $636 million last year in the U.S. and more than $14 million overseas. #


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