TreximetTreatment for Migraine
Update: Treximet Now FDA Approved - April 15, 2008
Pozen Submits Response to Approvable Letter for Trexima
CHAPEL HILL, N.C.--Oct 15, 2007 - POZEN Inc. announced today that it submitted a response to the Approvable letter for Trexima received on August 1, 2007. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter.
POZEN believes the submission constitutes a complete response. The submission includes, in addition to a required routine Safety Update and revised product labeling, the results of three non-clinical (in vitro) studies that provide clarifying information about a previously submitted non-clinical study, the Chinese Hamster Ovary (CHO) assay. The FDA may take up to six months to review this submission, although the company has requested a 60 day review.
In addition, while the non-clinical data are under review by the FDA, POZEN plans to conduct a clinical evaluation of the genotoxic potential of Trexima in a short-term study in human volunteers in the event the FDA requires this data. This study is expected to begin this quarter with results available for submission to and review by the FDA, if required, during the first quarter of 2008. "Although we believe that our submission addresses FDA's concern regarding the genotoxic potential of Trexima, we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required," said Dr. Marshall Reese, executive vice president, product development.
POZEN will hold a webcast to provide an update on Monday, October 15, 2007 at 11:00 a.m. Eastern time. 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 combining sumatriptan, formulated with RT Technology, 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 a proprietary fixed dose combination of naproxen with the proton pump inhibitor esomeprazole magnesium 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.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; our inability to know with certainty what standards the FDA will use to evaluate drug candidates and how that may change or evolve over time; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; the receipt of future development, regulatory or sales milestones and royalty payments from our collaboration partners; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended June 30, 2007. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Bill Hodges, Chief Financial Officer, 919-913-1030
Fran Barsky, Director, Investor Relations, 919-913-1044
Posted: October 2007
- FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients - May 15, 2015
- Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDAfor Acute Treatment of Migraine - April 16, 2008
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) - January 16, 2008
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - November 1, 2007
- Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days - October 5, 2007
- FDA Issues Second Approvable Letter for Trexima - August 2, 2007
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - March 22, 2007
- Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End - December 13, 2006
- Pozen Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006
- Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter - July 31, 2006
- Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment - June 9, 2006
- GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA - October 11, 2005
- POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine - August 8, 2005
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