Amylin Pharmaceuticals (AMLN) Gives Another Update

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. Such a decision could significantly delay the drug reaching the market. (that's a problem)
• Amylin CEO Daniel Bradbury told analysts on a conference call that the company has since received positive feedback from doctors. "Once physicians understand the context of the data they are comfortable continuing to prescribe Byetta," he said. "We haven't seen a major impact on Byetta prescribing."
• Kolterman said that of the two deaths reported by the FDA last week, one was of a male patient who weighed 400 pounds (181 kg) and had extensive gallstone disease. Gallstone disease is a common cause of pancreatitis. The second death was in a patient who had discontinued Byetta four months before being hospitalized with necrotizing pancreatitis.
• Among the latest four cases, one died of complications from surgery after gallbladder removal, the second died from a relapse of leukemia two and a half months after recovering from pancreatitis and a third died from intestinal bleeding following gallbladder removal. Little is known about the fourth case, Kolterman said.
• Malone said that media coverage of the deaths with Byetta "tended to be a bit sensationalized." He noted there has been only one report of pancreatitis for every 3,000 patients taking the drug for one year. While the company cannot rule out a connection between its drug and the pancreas problems, Malone said there have been reports of similar problems with rival medications. "With all other diabetes medications we know there has been pancreatitis, and some of those people have died," said Malone. "So it's not a unique phenomenon with Byetta." He added that diabetes patients are already three times more likely to develop pancreatitis compared with healthy patients.
• Malone also tried to ease concerns about the timeline for company's long-acting version of Byetta -- which is formulated for use once a week, instead of twice a day. He said the companies still hope to bring the drug to market by mid-2009 and that there are no plans for additional studies, despite the FDA's safety concerns.

So this appears to be an overblown reaction, but the thesis for purchasing is the mid 2009 launch of the once a week version and if that is at risk, our thesis changes. Need to do more reading but we might have to reconsider the position if this becomes an issue that delays the next iteration launch.

Long Amylin Pharmaceuticals in fund; no personal position