|POZEN and Xcel Announce Receipt of Not-Approvable Letter for MT 300; Pozen Reports MT 100 Regulatory Developments|
CHAPEL HILL, N.C. & SAN DIEGO--(BUSINESS WIRE)--Oct. 20, 2003--POZEN Inc. (NASDAQ:POZN) and Xcel Pharmaceuticals, Inc. (Xcel) announced today that POZEN received a not-approvable letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application for MT 300(TM). The letter was issued based on the FDA's conclusion that while MT 300 achieved its primary endpoint, it failed to achieve statistical significance versus placebo for the relief at two hours of the secondary symptoms of migraine (nausea, sensitivity to light, and sensitivity to sound). No clinical safety issues were identified in the letter, nor were any non-clinical issues cited as impacting the FDA's decision to issue the not-approvable letter.
In the letter, the FDA acknowledged that MT 300 provided a statistically significant improvement over placebo on the pre-defined primary endpoint of sustained pain relief (defined as relief of migraine pain at two hours that is maintained throughout the next 22 hours) as well as relief of pain at two hours post dose. The sustained relief of the secondary symptoms (defined as relief of secondary symptoms at two hours that is maintained throughout the next 22 hours) was a secondary endpoint in both of the Phase III trials. POZEN submitted data indicating that MT 300 provided statistically significant sustained relief of the secondary symptoms of migraine with the exception of sustained nausea relief, in one of the two Phase III trials.
"We are disappointed with the Agency's conclusion, but we are committed to working with the FDA to seek to resolve the issues raised in the letter as soon as possible," stated John R. Plachetka, Pharm.D., POZEN's chairman, president, and chief executive officer.
POZEN looks forward to meeting with the FDA to discuss the requirements for resolution of identified issues concerning the New Drug Application. The company does not expect the not-approvable letter for MT 300 will change its financial outlook for 2003.
MT 300 is being developed as a new formulation of dihydroergotamine mesylate (DHE) in a pre-filled syringe. DHE has been used for migraine treatment for over 50 years and is regarded as clinically effective by clinicians worldwide. The MT 300 New Drug Application was submitted to the FDA by POZEN in December 2002 and accepted for filing in February 2003.
Separately, POZEN announced that it received a letter of comments from an advisory group to the Medicines and Healthcare Products Regulatory Agency (MHRA), relating to the Marketing Authorization Application (MAA) for MT 100. POZEN submitted the MAA to the MHRA in October 2002 to obtain marketing approval of MT 100 for the acute treatment of migraine. Following standard procedure in the U.K., POZEN intends to submit a response to the comments raised by the advisory group.
POZEN to host webcast today at 10:00 a.m. Eastern Time
POZEN will host a webcast today, October 20, at 10:00 a.m. Eastern Time to discuss the information in this release. The webcast will be live and archived on POZEN's home page at www.pozen.com.
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 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.
About Xcel Pharmaceuticals
Xcel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on prescription products that treat disorders of the central nervous system (CNS). Xcel's portfolio includes four marketed products, two that are used to treat epilepsy and two that are used to treat migraine, and one product candidate to treat migraine. The Company's 96-person nationwide field sales organization promotes its products to high-prescribing epilepsy and migraine specialists. Xcel's strategy is to increase prescription demand for its key products through targeted sales and marketing efforts, to leverage its presence in the CNS market through the acquisition of late-stage development product candidates and additional commercial products, and to develop enhancements for its current products. For more information about Xcel Pharmaceuticals, please visit www.xcelpharmaceuticals.com. For more information about Xcel's products, please visit www.diastat.com, www.migranal.com, www.DHE45.com, and www.choosemysoline.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 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.
Xcel forward-looking statements: This press release contains forward-looking statements including targets, estimates, plans, expectations, goals and projections, which involve risks and uncertainties, including risks associated with receiving FDA approval for MT 300, our ability to successfully launch and grow MT 300, our ability to grow our products, our ability to acquire and integrate late-stage development product candidates and new products, our ability to develop and obtain regulatory approvals for product enhancements, our dependence on third parties for manufacturing, the competitiveness of the pharmaceutical industry, and other risks. Any forward-looking statements represent our best judgment at this time and are based on assumptions, factors and other conditions that could change. Any such changes could produce significantly different results. We do not update or revise any of our forward-looking statements even if experience or future events show that the projected results or events will not be realized.
CONTACT: POZEN Inc.