Healthcare Industry News: Trexima
News Release - December 13, 2006
Pozen Expects to Submit Revised Response to Trexima(TM) (Sumatriptan/Naproxen Sodium) Approvable Letter by Year EndCHAPEL HILL, N.C.--(HSMN NewsFeed)--POZEN Inc. (NASDAQ: POZN ) announced today that the U.S. Food and Drug Administration (FDA) has completed its initial review of POZEN's response to the June 8, 2006 Approvable Letter for Trexima(TM) and has determined the response is not yet complete. The FDA has requested additional analyses and supporting information relating to the data submitted in the November response.
Provision of the additional information will allow the FDA to determine the comparability of the new data submitted in November to that contained within the original Trexima NDA and to more fully assess the relative safety profile of Trexima. POZEN expects to prepare and submit the revised response before year end.
Dr. Marshall Reese, executive vice president, product development of POZEN stated, "We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response. Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima NDA, we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."
POZEN will hold a webcast to provide an overview on the Trexima full response clarification on Wednesday, December 13, 2006 at 8:30 a.m. Eastern Time. The call-in number for the webcast is 877-385-2370 (domestic) and 706-679-0866 (international). The access code is 4434183. A replay will be available beginning at 1:30 p.m. on Wednesday, December 13, 2006, and may be accessed by dialing 800-642-1687 (domestic) or 706-645-9291 (international) and entering the conference call code 4434183. The webcast can be accessed live and will be available for replay at www.pozen.com.
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for the proposed product candidate Trexima(TM) combining sumatriptan, formulated with RT Technology(TM), and naproxen sodium in a single tablet which is currently under review by the United States Food and Drug Administration for the acute treatment of migraine, and with AstraZeneca for proprietary fixed dose combinations of the proton pump inhibitor esomeprazole magnesium with naproxen in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
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