edit - it was briefly in the 15% fire sale club.
NEW YORK (AP) -- Shares of Amylin Pharmaceuticals Inc. fell Thursday following a Food and Drug Administration panel's recommendation for approval of a rival's diabetes treatment.
The stock fell 72 cents, or 6 percent, to $11.33 in afternoon trading. Shares have traded between $5.50 and $35 over the past 52 weeks.
On Wednesday, an FDA panel of experts recommended approval of New York-based Bristol-Myers Squibb Co.'s and London-based AstraZeneca's oral diabetes drug Onglyza, or saxagliptin. The panelists also recommended studies of heart safety after approval.
The agency is not required to follow the panel's recommendation, though it normally does.
Novo Nordisk's once-daily injectable drug liraglutide, which is expected to compete even more directly with Amylin's twice-daily Byetta injection, is facing a similar panel review Thursday.
Wall Street expects the FDA eventually to approve both Onglyza and liraglutide.
San Diego-based Amylin, along with Indianapolis-based Eli Lilly & Co. and Cambridge, Mass.-based Alkermes Inc., is developing a once-weekly version of Byetta, called exenatide LAR. The companies hope to ask for FDA approval in the second quarter. Like its potential competitors, though, that drug will face increased safety scrutiny by the agency over potential heart risks.
Bristol-Myers and AstraZeneca's Onglyza got a favorable 10 to 2 vote on the heart risk issue. But the same panel unanimously agreed that the drug should continue to be studied on high-risk patients to assure safety.
Novo Nordisk is likely to face the same scrutiny, as is Amylin and partners when LAR comes under review.
"It is difficult to gauge FDA or the panel's willingness to accept the liraglutide cardiovascular data, but at a minimum we feel post-approval studies will be required," said Thomas Weisel analyst M. Ian Somaiya, adding that the agency could require a safety study before the drug is approved. |
