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; nathalie.tadena@dowjones.com