Byetta Talk Leads Amylin to Fall Further
08/27/08 - 05:31 PM EDT
Elizabeth Trotta
Updated from Aug. 26
Shares of Amylin (AMLN Quote - Cramer on AMLN - Stock Picks) fell 25% Wednesday as Wall Street opined on recent cases of pancreatitis and deaths in patients taking the company's diabetes drug Byetta. Also top of mind were possible effects on a prospective long-acting version of the drug. On a conference call Tuesday evening, the company and its partner Eli Lilly (LLY Quote - Cramer on LLY - Stock Picks) disclosed four additional deaths in patients who had taken Byetta -- the newest bit of the discussion surrounding the elusive connection between pancreatitis and the drug. In October 2007, the Food and Drug Administration issued an alert that it received 30 post-marketing reports of acute pancreatitis in patients taking Byetta. Amylin updated the label to include information about acute pancreatitis in the precautions section of the label. Last Monday, regulators warned that Byetta, which accounted for more than 80% of Amylin's revenue in the first half of 2008, could be connected to six cases of severe pancreatitis, two of which resulted in death. Amylin said in the conference call Tuesday that the four additional deaths occurred in patients with Type II diabetes who were taking Byetta and diagnosed with pancreatitis -- although executives said those deaths were not directly attributable to pancreatitis. The FDA had been told of the deaths, but the agency hadn't disclosed them to the public. The companies reiterated Tuesday that it's ultimately still unknown what, if any, role Byetta played in the rare cases of pancreatitis, and the companies reiterated they continue to believe in the drug's positive risk-benefit profile for patients with type II diabetes. The overall risk of pancreatitis is three times greater in patients with Type II diabetes than it is in the general population. The FDA said last week that it was working with the companies to add stronger warnings in the product label around the risk of necrotizing or acute hemorrhagic pancreatitis. The companies said Tuesday that the discussion is ongoing and that there have been no formal recommendations made at this point.
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