|POZEN Presents Data Demonstrating That a Two Tablet Dose of MT 100 Appears More Effective Than Imitrex 50 mg in Migraine Patients with Nausea or Severe Pain|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Sept. 16, 2003--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company developing therapeutic advancements in a cost effective manner, announced today the presentation of data from four posters at the XI Congress of the International Headache Society in Rome.
One of the presentations highlighted data from a Phase III study with a special focus on migraine patients with severe pain or nausea at baseline. The data demonstrated that a two-tablet dose of MT 100(TM) appears to be more effective in providing pain relief at two hours than a single tablet dose of Imitrex(R) 50 mg in migraine patients with severe pain or nausea at baseline. In addition, both a one and two-tablet dose of MT 100 show an improvement over Imitrex 50 mg in providing nausea relief during the first two hours in patients with severe pain at baseline. Another presentation showed that MT 100 was well tolerated in a long-term safety study. Top line results from the aforementioned studies were announced by POZEN in the company's prospectus for its initial public offering dated October 10, 2000 and in a press release dated September 5, 2002.
"MT 100 has consistently demonstrated its effectiveness in treating migraine pain," stated John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN. "We believe that MT 100's ability to elicit rapid and long-lasting migraine symptom relief with easy tolerability will make it the drug of choice for first-line prescription therapy." POZEN submitted a New Drug Application for MT 100 to the U.S. Food and Drug Administration in July 2003.
The posters can be viewed and downloaded by visiting POZEN's home page at www.pozen.com. Highlights of the poster presentations:
Abstract #: P5N39
Title: Comparative Efficacy of MT 100 and Sumatriptan 50 mg (Imitrex 50 mg) in Treating Acute Migraine Subjects with Severe Pain or Nausea at Baseline
The results of a double-blind, placebo controlled study demonstrated that a one and two-tablet dose of MT 100 showed an improvement over Imitrex 50 mg and placebo in relief of nausea during the first two hours in patients with severe pain at baseline. Also, a two-tablet dose of MT 100 appears to be more effective than a single dose of Imitrex 50 mg in patients with either severe pain or nausea at baseline.
Abstract #: P5N14
Title: Tolerability Profile of MT 100 During One Year of Treatment
The findings demonstrated that single tablet doses of MT 100 administered intermittently over a 12-month period for the treatment of acute migraine are associated with a favorable safety profile.
Abstract #: P5N45
Title: MT 300 is an Effective, Well Tolerated Injectable Antimigraine Therapy
Two randomized double-blind, placebo controlled, multicenter studies demonstrated that MT 300 is well tolerated and significantly more effective for the sustained relief of migraine pain than placebo. In both studies, MT 300 provided significantly more sustained pain relief and significantly more sustained pain free than placebo. In patients with severe pain at baseline, the difference between MT 300 and placebo was even greater in both studies. MT 300 is being developed as an improved and highly purified formulation of dihydroergotamine mesylate (DHE) in a convenient pre-filled syringe that is suitable for at-home use.
Abstract #: P5N32
Title: Time Course of Symptom Relief with Various Anti-Migraine Therapies
This study found that a combination of an NSAID and sumatriptan showed a consistent benefit with regard to the relief of pain and associated migraine symptoms compared to other treatments. These results suggest that targeting more than one mechanism of pain is crucial in treating moderate to severe pain.
The poster presentation titled "Time Course of Symptom Relief with Various Anti-Migraine Therapies" was one of four posters out of 118 at the scientific meeting accepted for oral presentation.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel, 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.
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 FDA approval of our product candidates, resulting in, among other things, 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 Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2003 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.