Press Release

Printer Friendly Version View printer-friendly version
<< Back
POZEN Submits New Drug Application for Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 8, 2005--POZEN Inc. (NASDAQ: POZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of Trexima(TM), the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology (TM), and naproxen sodium, in a single tablet for the acute treatment of migraine.

Dr. Marshall Reese, executive vice president, product development stated, "We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA. This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline (GSK) and POZEN."

Upon the FDA's acceptance for filing of the Trexima NDA, a $20 million milestone payment from GSK is payable to POZEN.

About Migraine

Migraine affects more than 28 million people in the Unites States alone, of which roughly three out of four migraine sufferers are women. According to the International Headache Society's diagnostic criteria, migraine is characterized by recurrent headaches lasting 4 to 72 hours (untreated) and with symptoms including moderate to severe headache pain, throbbing head pain, head pain located on one side of the head, head pain aggravated by routine activity, nausea, vomiting, and sensitivity to light and sound. Migraine can be disabling and sufferers may miss days of work, lose time with family and friends, and be unable to pursue basic daily activities.

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. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of migraine. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has development and commercialization alliances with GlaxoSmithKline, Valeant Pharmaceuticals North America, a subsidiary of Valeant Pharmaceuticals International (formerly Xcel Pharmaceuticals, Inc.), and Nycomed Danmark ApS. 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/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any 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 Quarterly Report on Form 10-Q for the period ended June 30, 2005 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.

CONTACT:
POZEN Inc.
Bill Hodges
Chief Financial Officer
919-913-1030
Fran Barsky
Director, Investor Relations
919-913-1044

SOURCE: POZEN Inc.


Replication or redistribution of EDGAR Online, Inc. content is expressly prohibited without the prior written consent of EDGAR Online, Inc. EDGAR Online, Inc. shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.