June 27, 2012

A Glitch in the GLP-1 Story

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This is the story of Byetta, the 2006 blockbuster drug introduced by Amylin Pharmaceuticals and Eli Lilly. Was the drug too good to be true? Well, according to documents recently released to the FDA, Byetta has more of a story than initially told.

Byetta is a Type 2 diabetes drug that stimulates insulin secretion and slows the gastric emptying to curb the rise in post meal blood glucose. Byetta can be injected several times a day. Bydureon is the same type of drug in an extended-release form, so it only requires one injection per week.

Amylin Pharmaceuticals concealed a study from the FDA that raised heart safety concerns about Byetta and then hindered FDA access to the data when the agency discovered its existence.

To add insult to injury, Amylin executives lied to investors by failing to disclose that this hidden Byetta heart-safety study played a key role in FDA rejecting the company’s follow-on diabetes drug Bydureon. Injurious to patients, insulting to investors. Attaboy, Amylin!

Bristol-Myers Squibb made an unsolicited offer to buy Byetta from Amylin. The offer wasn’t tempting enough for Amylin to bite. However the proposal must have sparked some interest in selling Byetta because the search for a new Big Pharma to pimp Byetta has led us to the deep throat of Byetta’s dirty little secrets.

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