|POZEN and GSK Announce Start of Phase III Program for Trexima, a Novel Migraine Treatment; POZEN Will Receive Phase III Initiation Milestone Payment of $15 Million|
CHAPEL HILL & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--May 18, 2004--POZEN (NASDAQ: POZN) and GlaxoSmithKline (NYSE: GSK) today announced the start of the Phase III program for Trexima(TM). Trexima is the proposed brand name for the combination of sumatriptan (5-HT1B/1D agonist) and naproxen sodium in a single tablet.
The Phase III program will begin immediately. POZEN will conduct two Phase III pivotal trials, designed to determine the effectiveness and safety of Trexima for the acute treatment of migraine. In addition, POZEN will conduct a long-term, open label safety study.
"Moving into Phase III is a major step in the development of this important new medicine," said Stan Hull, GSK Senior Vice President, US Pharmaceuticals. "GSK has long been a leader in discovering and developing migraine treatments, and we are pleased to be working with POZEN to move Trexima into the final stage of development."
"We look forward to a rapid development program for Trexima, with a targeted NDA filing in the second half of 2005. We believe Trexima, which uses POZEN's MT 400(TM) technology, has the potential to be one of the best treatments for migraine," said John R. Plachetka, Pharm.D., POZEN's Chairman, President and Chief Executive Officer.
POZEN and GSK signed an agreement in June 2003 for the development and commercialization of proprietary combinations of a triptan (5-HT1B/1D agonist) and a non-steroidal anti-inflammatory drug (NSAID), including the combination that makes up Trexima. Under the agreement, POZEN is responsible for the pre-clinical, clinical, and regulatory development activities for Trexima, while GSK is responsible for formulation development, manufacturing and commercialization. The commencement of the Phase III program will trigger a $15 million development milestone payment to POZEN by GSK. The companies expect the New Drug Application (NDA) for Trexima to be filed in the second half of 2005.
Migraine afflicts approximately 28 million people in the United States alone, of which roughly three out of four migraine sufferers are women. Migraine attacks can last from 4 hours to 72 hours and are typically characterized by sharp pulsating pain on one side of the head, nausea, and extreme sensitivity to light and sound. While the precise mechanism of migraine is unknown, researchers believe migraine attacks are caused by acute inflammation surrounding selected vessels in the head. The average migraine sufferer experiences the first attack during the early teen years, and the attacks generally continue throughout adulthood.
Imitrex (sumatriptan) tablets are approved for the acute treatment of migraines with or without aura in adults and are available by prescription in pharmacies nationwide. Imitrex should only be used when a clear diagnosis of migraine has been established by a physician. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.
About Naproxen Sodium
Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox(R), Anaprox DS(R), Naprelan(R), Aleve(R) and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.
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 developed what it believes to be one of the largest and most advanced product pipelines in the field of migraine. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel Pharmaceuticals, and Nycomed. 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.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website: www.gsk.com.
POZEN forward looking statements
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, or the failure to obtain such approval 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 our Form 10-Q for the quarter ended March 31, 2004 under "Management's Discussion and Analysis 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.
GSK Cautionary Statement regarding forward-looking statements: Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations include, but are not limited to, those described under 'Risk Factors' in the Operating and Financial Review and Prospects in GSK's Annual Report on Form 20-F for 2002.
CONTACT: POZEN Inc.
SOURCE: POZEN Inc.