Amylin, Eli Lilly And Alkermes Submit Reply To FDA On Bydureon

Date : 07/28/2011 @ 9:30AM
Source : Dow Jones News
Stock : Amylin Pharmaceuticals, Inc. (MM) (AMLN)
Quote : 30.98  0.0 (0.00%) @ 2:05AM

Amylin, Eli Lilly And Alkermes Submit Reply To FDA On Bydureon

Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart

5 Years : From Jul 2012 to Jul 2017

Click Here for more Amylin Pharmaceuticals, Inc. (MM) Charts.

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 
 

Latest AMLN Messages

{{bbMessage.M_Alias}} {{bbMessage.MSG_Date}} {{bbMessage.HowLongAgo}} {{bbMessage.MSG_ID}} {{bbMessage.MSG_Subject}}

Loading Messages....


No posts yet, be the first! No {{symbol}} Message Board. Create One! See More Posts on {{symbol}} Message Board See More Message Board Posts


Your Recent History
LSE
GKP
Gulf Keyst..
LSE
QPP
Quindell
FTSE
UKX
FTSE 100
LSE
IOF
Iofina
FX
GBPUSD
UK Sterlin..
Stocks you've viewed will appear in this box, letting you easily return to quotes you've seen previously.

Register now to create your own custom streaming stock watchlist.


NYSE, AMEX, and ASX quotes are delayed by at least 20 minutes.
All other quotes are delayed by at least 15 minutes unless otherwise stated.