Pozen Frozen on FDA Data Request
Biotech
Pozen Frozen on FDA Data Request
By Althea Chang
TheStreet.com Staff Reporter
12/13/2006 10:24 AM EST
URL: http://www.thestreet.com/newsanalysis/biotech/10327629.html
Shares of drugmaker Pozen (POZN) sank Wednesday after regulators said that further data must be submitted before the company's experimental migraine drug Trexima can be approved for marketing.
Shares were down $1.84, or 10.2%, to $16.27.
After reviewing the company's initial application early this year, the Food and Drug Administration requested additional information on the drug, a combination of the pain relievers sumatriptan and naproxen sodium, through a so-called approvable letter, in June.
The company responded to the agency's request in November, but regulators are saying the reply is still incomplete. Pozen expects to submit additional data, which are required to fully assess the drug's safety, before the end of the year.
"We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response," said Dr. Marshall Reese, Pozen's executive vice president of product development. "Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima [new drug application] , we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."
Pozen Frozen on FDA Data Request
By Althea Chang
TheStreet.com Staff Reporter
12/13/2006 10:24 AM EST
URL: http://www.thestreet.com/newsanalysis/biotech/10327629.html
Shares of drugmaker Pozen (POZN) sank Wednesday after regulators said that further data must be submitted before the company's experimental migraine drug Trexima can be approved for marketing.
Shares were down $1.84, or 10.2%, to $16.27.
After reviewing the company's initial application early this year, the Food and Drug Administration requested additional information on the drug, a combination of the pain relievers sumatriptan and naproxen sodium, through a so-called approvable letter, in June.
The company responded to the agency's request in November, but regulators are saying the reply is still incomplete. Pozen expects to submit additional data, which are required to fully assess the drug's safety, before the end of the year.
"We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response," said Dr. Marshall Reese, Pozen's executive vice president of product development. "Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima [new drug application] , we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."
posted by B at 7:49 PM
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