Pozen sinks on FDA request

Pozen sinks on FDA request
By Val Brickates Kennedy, MarketWatch
Last Update: 4:35 PM ET Dec 13, 2006

BOSTON (MarketWatch) -- Shares of Pozen Inc. tumbled Wednesday on news that regulators want additional data for its proposed migraine medication Trexima before they will consider approving the drug.
POZN shares closed down 11% at $16.09, after hitting a session low of $15.06.
In a release, Pozen said that the Food and Drug Administration is still requesting "additional analysis and supporting information" for Trexima as part of an approvable letter it issued the drug on June 8. An approvable letter means that the agency will consider approving the drug if more information is provided.
Pozen submitted additional information in response to the approvable letter in early November. On Wednesday, Pozen said it expects to fulfill the FDA's latest request by the end of the year.
Trexima is a combination of the generic pain reliever naproxen and GlaxoSmithKline's popular migraine drug Imitrex, which is slated to lose patent protection around 2009. Imitrex is known generically as sumatriptan.
"Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima NDA (new drug application), we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan," said Marshall Reese, Pozen's executive vice president for product development, in a statement.
Imitrex had combined sales of $1.1 billion in 2005, according to Pozen's website. Trexima was co-developed by Pozen and Glaxo. End of Story
Val Brickates Kennedy is a reporter for MarketWatch in Boston.