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POZEN Announces Receipt of $20 Million in Milestone Payments from GlaxoSmithKline
Posted: 04-29-2008 : CHAPEL HILL, N.C.
CHAPEL HILL, N.C. -- POZEN Inc. (NASDAQ: POZN), announced the receipt of a total of $20 million in milestone payments from GlaxoSmithKline (GSK) for the U.S. Food and Drug Administration approval of, and GSK’s intent to commercialize, Treximet™ (sumatriptan and naproxen sodium) for the acute treatment of migraine in adults, the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, and an anti-inflammatory pain reliever in a single tablet.
Dr. John R. Plachetka, chairman, president and chief executive officer said, “We are extremely pleased that the FDA has approved Treximet and are very excited that GSK has already begun the process to commercialize the drug with expected availability in pharmacies by mid-May.”
Treximet contains 85 mg sumatriptan, formulated with RT Technology™, and 500 mg naproxen sodium. In clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.
Important Safety Information
Prescription Treximet is indicated for the acute treatment of migraine attacks, with or without aura, in adults. Treximet should only be used where a clear diagnosis of migraine headache has been established.
Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Treximet contains a non-steroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Please consult complete Prescribing Information available at www.Treximet.com.
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. 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 Treximet™, which was recently approved by the United States Food and Drug Administration for the acute treatment of migraine attacks with or without aura in adults, and with AstraZeneca for proprietary fixed dose combinations 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.
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