Amylin, Eli Lilly to Address Byetta Concerns

Amylin(AMLN Quote) and partner Eli Lilly(LLY Quote) said they will hold a conference call Tuesday evening to discuss a Food and Drug Administration advisory on a diabetes treatment that could be linked to two recent deaths.

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 deaths. The FDA said it was working with the companies to add stronger warnings in the product label around the risk of necrotizing or acute hemorrhagic pancreatitis.

Ultimately it's still unknown what -- if-any -- role Byetta played in the rare cases of pancreatitis. There was no direct causal role found in patients the companies followed before, said Lazard Capital Markets analyst Matt Osborne last week. Moreover, Osborne noted that the overall incidence is low when you consider more than a million prescriptions have been written thus far.

Osborne, who maintained a hold rating for the stock, doesn't expect the cases will affect near-term sales or the company's filing for Byetta LAR, which the Street is expecting in the second quarter of 2009 at the latest.

Still, he said, it sounds like the FDA is considering stricter language. And while the current label has a precaution, the FDA could try to take that to a more severe, black-box warning.

The call is scheduled for 5 p.m. Amylin shares closed up 4.5%, at $27.77 on Monday, and were rising 0.7% in recent post-market activity. Lilly's shares closed down 1.06%, at $47.52, and were flat in recent after-hours trading.