Amylin Pharmaceuticals Inc.(AMLN) expects to update the label of diabetes treatment Byetta, co-marketed with Eli Lilly & Co. (LLY), and get a U.S. Food and Drug Administration decision during the first quarter on its use as a monotherapy.

Last year, news of patient deaths from severe pancreatitis led the FDA to start working with the companies on amending its label to "add stronger and more prominent warnings" about the risk of the pancreatic inflammation.

Shares of Amylin recently traded down 63 cents, or 5.4%, to $11.06.

Amylin Chief Executive Daniel Bradbury made the comments at a JPMorgan health-care conference in San Francisco and reiterated that a once-weekly formulation of the drug, in development with Lilly and Alkermes Inc. (ALKS), remains on track to be filed with the FDA in the first half of 2009.

The disclosure of the deaths raised concern on Wall Street that the filing timeline for the long-acting version would be delayed and alter its hoped-for 2010 approval. At the conference, Bradbury stressed that there is no proven relationship between Byetta and pancreatic side effects.

Amylin, which launched a restructuring plan in November, still expects to be cash flow positive by the end of 2010, he said.

Bradbury also said the FDA will allow Amylin to proceed with a meta-analysis of prior data in its application for the once-weekly Byetta to show that there is no increased risk of cardiovascular events associated with the drug.

The discussion with regulators was prompted by December recommendation from the FDA for more stringent clinical trials for diabetes drugs to better assess heart attack and stroke risks.

Bradbury said the company has also submitted the results from an insurance database analysis to the FDA that shows that there was no statistical difference in cases of acute pancreatitis in Byetta users compared with other diabetes patients.

-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com

Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary. You can use this link on the day this article is published and the following day.