|POZEN Presents Phase III Data Demonstrating That MT 300 is Effective in Providing Sustained Pain Relief for the Acute Treatment of Migraine|
Data Presented at The American Headache Society's 45th Annual Scientific Meeting
CHAPEL HILL, N.C.--(BUSINESS WIRE)--June 23, 2003--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company developing therapeutic advancements in a cost effective manner, announced today the presentation of data from three posters at the 45th Annual Scientific Meeting of The American Headache Society (AHS) in Chicago. One of the presentations highlighted data from a Phase III study demonstrating that MT 300 is effective in providing sustained pain relief for the acute treatment of migraine. MT 300 is being developed as a new, improved formulation of dihydroergotamine (DHE) in a convenient pre-filled syringe that is suitable for at-home use. Top line results from the studies were announced by POZEN in press releases issued on July 22, 2002 and October 4, 2002.
"As migraine attacks differ in severity, so should treatment options," stated John R. Plachetka, Pharm.D., chairman, president and chief of executive officer of POZEN. "At POZEN, we are currently developing three product candidates that are designed to treat the full range of migraine attacks. We are excited to present data on MT 300 and believe it has the potential to offer patients a convenient and effective injectable therapy for their migraine attacks." POZEN submitted a New Drug Application for MT 300 to the U.S. Food and Drug Administration in December 2002.
The Company's three presentations were:
The results of two randomized double-blind, placebo-controlled, multicenter studies performed in patients with acute migraine attacks showed that MT 300 was well tolerated and significantly more effective for the sustained relief of migraine pain than placebo. Furthermore, MT 300 provided a convenient and easy to use package for patient self-administration.
Efficacy data obtained from subjects who treated severe migraine headaches with one of three different treatments were used as example data to illustrate how different pain measures can be interpreted. The presentation concluded that while measures of pain response at 2 hours allow some treatments to appear effective, only sustained measures of pain responses incorporated the use of rescue medication and pain relapse over time. Sustained pain response measures (particularly pain free) are most closely aligned with patients' expectations of treatment success.
Title: Barriers to the Use of Oral Triptans by Patients Diagnosed with Migraine Headaches. The findings presented in this study were derived from a usage and attitude study with migraineurs designed to investigate current migraine treatment use and satisfaction with existing therapies. The study concluded that efficacy, side effects, and cost are barriers to using oral triptans for migraine treatment.
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.
POZEN is a pharmaceutical company developing therapeutic advancements in a cost effective manner. Since its inception, POZEN has developed the largest and most advanced product pipeline in the field of migraine. Product development efforts are focused on diseases with unmet medical needs where POZEN can improve efficacy, safety, and/or patient convenience. POZEN recently signed a development and commercialization agreement with GlaxoSmithKline for a novel migraine treatment. The company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN." For detailed company information, see POZEN's website: www.pozen.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 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 enter into or maintain, 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 March 31, 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.