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发帖数: 462 | 1 Amylin Pharmaceuticals Inc., Eli Lilly & Co. and Alkermes Inc. dropped in
early trading after they were rebuffed a second time in a bid to gain
approval of a once-weekly version of the diabetes drug Byetta.
The Food and Drug Administration “blindsided” the companies late yesterday
by calling for a study assessing the heart risks for the new drug Bydureon,
said Phil Nadeau, an analyst with Cowen & Co. in New York.
The FDA restricted the use last month of GlaxoSmithKline Plc’s diabetes
drug Avandia, which was found to increase heart attack risk in 2007 after
eight years on the market. The agency, stung by criticism it moved too
slowly, acted against Avandia as European regulators ordered the medicine
withdrawn. The agency hadn’t requested any new studies when it declined to
approve Amylin’s application for Bydureon on March 15 and asked for more
information about a risk-management plan.
“It seems like another instance where the FDA surprised a company and it
doesn’t seem like Amylin did anything wrong,” Nadeau said yesterday by
telephone. “Seems like they got blindsided and that’s happening more and
more.”
Amylin declined $10.01, or 49 percent, to $10.48 at 7:55 a.m. New York time
before the Nasdaq Stock Market opened. Alkermes, based in Waltham,
Massachusetts, dropped $3.70, or 26 percent, to $10.80. Indianapolis-based
Lilly fell $1.45, or 3.9 percent, to $36.
Expectations for Approval
Nadeau and other analysts expected Bydureon to be cleared for sale this week
. The drug now will be delayed by as long as 20 months based on a timetable
the company outlined in a conference call with analysts, he said.
Had Bydureon been approved, Nadeau estimated 2011 sales of $420 million. San
Diego-based Amylin, which had revenue of $758.4 million in 2009, canceled
plans for a conference call scheduled today to discuss the company’s third-
quarter earnings.
Chief Executive Officer Daniel Bradbury said the company has the cash
resources to get through the longer time to bring the drug to market. Amylin
plans to respond to the FDA with the results of the heart-risk research by
the end of 2011, and the agency may take as long as six months to respond,
Bradbury said on a conference call.
“We’ve tried to estimate conservatively,” Bradbury said. “The reality is
that we don’t get to control all estimates of this timeline.” |
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