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Cholesterol Drug Battle: Niaspan vs. Zetia 16 Nov 2009
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Pharma's Market

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Sep.04

12:26 PM ET

Thursday, 4 Sep 2008

Amylin's Byetta Battle

Posted By:Mike Huckman

Topics:Pharmaceuticals

Sectors:Health Care Equipment and Services | Health Care | Pharmaceuticals

Companies:Eli Lilly and Company | Amylin Pharmaceuticals

Of the 36 companies presenting here at the BioCentury/Thomson Reuters biotech conference, investors are probably most interested in the update from Amylin Pharmaceuticals.

The stock has been on a slide since the FDA and the company disclosed a total of six deaths among diabetics who developed pancreatitis after taking Byetta, the twice-a-day injectable drug from AMLN[AMLN Loading... () ] and Eli Lilly[LLY Loading... () ].

The CFO Mark Foletta did the presentation to the approximately 100 people in the room. CEO Dan Bradbury didn't make it. Foletta went over the facts that I reported on "Fast Money" when the news broke last week--media coverage that he said has "created some confusion in the marketplace."

"While serious," Foletta said, "it's a condition that is rare and is not new. There's no definitive causal relationship between Byetta and pancreatitis, but a possible association is being explored."

Foletta said he thinks the FDA could change the Byetta label regarding the suspected pancreatitis risk around the time it's expected to make a decision on the approval of Byetta for use as a stand-alone treatment for diabetes. That's supposed to happen, Foletta said, by the end of the year.

He also mentioned--and I think this might be new-- that a "major national insurance carrier" informed the company late last week that among the nearly 40,000 patients it has on Byetta there is "no difference" in the incidence of pancreatitis versus diabetics on other drugs.

One observation, though. Foletta didn't acknowledge the elephant in the room--the pancreatitis-related deaths--until around seven minutes into his formal presentation. In the news biz, that's called burying the lead.