POZEN Submits New Drug Application for Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine.CHAPEL HILL, N.C. -- POZEN Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : POZN) announced the submission of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the marketing approval of Trexima(TM), the proposed brand name for the combination of sumatriptan succinate sumatriptan succinate (soo´m Aflaxen, Aleve, Anaprox, Anaprox DS, Apo-Napro-Na (CA), Apo-Napro-Na DS (CA), Arthroxen (UK), Napratec (UK), Naprelan, Novo-Naprox Sodium (CA), Novo-Naprox Sodium DS (CA), Synflex (CA), Synflex (UK) Pharmacologic class: , in a single tablet for the acute treatment of migraine. Dr. Marshall Reese, executive vice president, product development stated, "We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA. This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) and POZEN." Upon the FDA's acceptance for filing of the Trexima NDA, a $20 million milestone payment from GSK is payable to POZEN. About Migraine Migraine affects more than 28 million people in the Unites States alone, of which roughly three out of four migraine sufferers are women. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches lasting 4 to 72 hours (untreated) and with symptoms including moderate to severe headache pain, throbbing throb intr.v. throbbed, throb·bing, throbs 1. To beat rapidly or violently, as the heart; pound. 2. To vibrate, pulsate, or sound with a steady pronounced rhythm: head pain, head pain located on one side of the head, head pain aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound. Migraine can be disabling and sufferers may miss days of work, lose time with family and friends, and be unable to pursue basic daily activities. About POZEN 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. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of migraine. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has development and commercialization alliances with GlaxoSmithKline, Valeant Pharmaceuticals North America, a subsidiary of Valeant Pharmaceuticals International Valeant Pharmaceuticals International is a pharmaceutical company with activities spanning the drug discovery pipeline from target identification through clinical trials and commercialization. (formerly Xcel Pharmaceuticals, Inc.), and Nycomed Danmark ApS. The company's common stock is traded on The Nasdaq Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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; 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; 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 Quarterly Report on Form 10-Q for the period ended June 30, 2005 under "Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations." We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. |
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