Three partners on diabetes drug Bydureon--Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly & Co. (LLY) and Alkermes Inc. (ALKS)--submitted a response to the U.S. Food and Drug Administration that includes additional data indicating the drug didn't slow heart rates.
The FDA requested further testing for the drug last year. Bydureon's success is key to the future of Amylin, which hasn't reported a profit since going public in 1992. The drug also would be a positive development for Lilly, which is seeking new drugs to offset looming generic competition to its top products. European regulators approved the treatment last month.
The companies' reply includes results from a recently completed survey that shows that exenatide--the drug's nontrade name--at and above therapeutic levels didn't prolong corrected heart intervals in healthy individuals. It also includes an update of safety information from ongoing or completed studies since the companies' last response.
"We are confident that the study results and our detailed submission have addressed the requirements outlined by the FDA, and we remain committed to making Bydureon available to patients in the U.S. as soon as possible," said Christian Weyer, senior vice president, research and development, for Amylin.
The companies said they expect to receive an updated Prescription Drug User Fee Act action date from the FDA in two weeks. The companies said their resubmission could take up to six months for review.
Amylin shares, down 37% over the past 12 months, closed at $11.96 on Wednesday and were inactive premarket. Lilly shares, up 6.5% over the past 12 months, fell 0.7% in premarket trading to $37.72. Alkermes shares, up 34% over the past 12 months, closed at $17.55 and were inactive premarket.
-By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; firstname.lastname@example.org