Amylin Pharmaceuticals Gives Another Update
By:
TraderMark Wednesday, August 27, 2008 10:39 AM
Some very conflicting reports coming out of
Amylin Pharma (AMLN) - 4 "more" deaths but not "linked to the drug". I took some off the table yesterday in the $28s as
I mentioned I would as it neared resistance ($29) so we only have about a 0.5% stake but the drama here is immense. The stock was down 8% in after hours yesterday. Hard to make heads or tails of
these different "takes" from the new data. These are not new deaths, just ones the FDA did not report last week due to their nature. Of the 4 new deaths, 1 has little information and the other 3 sound like they have nothing to do with the drug. But it's all about sentiment and human emotion in the short run in the stock market. Ah, the fun of biotech.
- Amylin Pharmaceuticals Inc (AMLN) said there have been four deaths among patients with pancreatitis who took its diabetes drug, Byetta, in addition to two deaths reported last week by U.S. regulators.
- The company said the four cases had not been captured in the report last week by the Food and Drug Administration, which said it had received six reports of patients who developed hemorrhagic or necrotizing pancreatitis that required hospitalization. Two of those patients died.
- The additional four cases did not involve patients with the necrotizing form of the disease, which affects 15 percent to 20 percent of patients with inflammation of the pancreas, said Amylin
- Orville Kolterman, Amylin's senior vice president of research and development, said in an interview the four deaths were not considered related to the pancreatitis. "It appears the FDA focused on necrotizing and hemorrhagic pancreatitis, whereas these other four cases only had pancreatitis in their history," Kolterman said. In the necrotizing form of pancreatitis, enzymes digest the pancreas, which can lead to a hemorrhage.
- Even so, he said the company was reporting them "in the interests of transparency."
- Canaccord Adams analyst Adam Cutler said the company was trying to make a case for why pancreatitis is unlikely to be caused by Byetta, "yet the FDA is concerned." Given the FDA's concerns, Cutler said: "I'm wondering whether they will have to do longer, larger, safety trials" of the version that is designed to stay in the body for a full week.
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