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FDA seeks added data on Trexima
AFX-Europe - June 9, 2006 12:50 PM (EDT)
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NEW YORK (AFX) - Drug developer Pozen Inc. and pharmaceutical giant
GlaxoSmithKline PLC said Friday that the Food and Drug Administration has issued an
approvable letter for their migraine treatment Trexima.
However, the agency also requested added safety information on Trexima, which may
require new studies. Shares of Pozen plunged $7.22 on the news, or 51 percent, to $6.89
on the Nasdaq. Earlier in the session, the stock touched a fresh 52-week low of $6.55,
erasing its prior trough of $7.25.
An approvable letter is an official notification which contains conditions that must
be satisfied prior to obtaining final U.S. marketing approval.
Pozen and GlaxoSmithKline plan to request a meeting with the agency as quickly as
possible to determine the appropriate next steps to gain full approval.
The treatment combines GlaxoSmithKline's Imitrex, which uses Pozen's RT Technology,
with naproxen sodium, a nonsteroidal anti-inflammatory drug. RT Technology allows drugs
to quickly dissolve and disperse in the stomach, especially when stomach movement is
slowed down, a common occurrence during a migraine.
The companies, which submitted the application in August, had expected to have the
treatment approved and on the market by the second half of 2006.
American depositary shares of London-based GlaxoSmithKline shed 57 cents to $54.83 on
the New York Stock Exchange.