* FDA asks for heart rate study
* Companies say FDA decision now pushed to mid-2012
* Amylin cancels Wednesday earnings conference call
(Adds byline, company comments, background)
By Deena Beasley
LOS ANGELES, Oct 19 U.S. health regulators
declined on Tuesday to approve a diabetes drug being developed
by Amylin Pharmaceuticals Inc's AMLN.O and Eli Lilly and Co
(LLY.N), citing the need for further studies, including the
drug's effect on heart rate.
The companies said they aim to reply to the Food and Drug
Administration by the end of next year. They expect the next
review of the drug, Bydureon, to have a six-month clock --
meaning a final FDA decision could come by mid-2012.
Shares of Amylin, which fell 3.4 percent in regular
trading, were halted after hours. Shares of Lilly were down 2.5
percent after hours at $36.50.
Analysts have projected annual sales of over $1 billion if
Bydureon is approved by regulators.
The FDA requested in a "complete response letter" a
thorough study of the impact of the drug's main component,
exenatide, on heart muscle, Amylin and Lilly said in a
In addition, the agency has requested results from an
ongoing study of the drug.
"In preclinical and clinical trials ... exenatide has not
demonstrated any increase in cardiovascular complications due
to QT prolongation or arrhythmia disorders," Amylin Chief
Executive Daniel Bradbury said on a conference call.
Bydureon, which employs technology from Alkermes Inc
(ALKS.O), is a once-weekly version of diabetes drug Byetta,
which is currently sold by Amylin and Lilly.
Byetta, also known as exenatide, is approved for the
treatment of type II diabetes -- the more common form of the
disease that is closely linked to obesity.
The companies had resubmitted Bydureon to the FDA in May
after the agency sent the company a previous complete response
letter in March requesting final information for the drug's
label as well as a risk evaluation and mitigation strategy.
Separately, Amylin said its unaudited third quarter net
product sales fell to $154 million, including $132.4 million
for Byetta, from the year earlier period's $192.9 million,
including $171 million for Byetta.
The company, which had been slated to report full results
for the quarter on Wednesday, said it will issue the report
within the next few weeks.
Bradbury said he believes that Amylin has adequate
financial resources to take the company through to the launch
(Reporting by Deena Beasley; editing by Sofina Mirza-Reid and