|POZEN Receives Approval for MT 100 in the United Kingdom|
CHAPEL HILL, N.C., Nov 28, 2005 (BUSINESS WIRE) -- POZEN, Inc. (NASDAQ: POZN), a pharmaceutical company focused primarily on products for the treatment of acute and chronic pain, migraine and other pain-related conditions, announced today the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Marketing Authorization for MT 100 for the acute treatment of migraine.
MT 100 was developed as an oral, first-line treatment for migraine. It is a patented sequential release tablet containing two approved drugs, naproxen sodium, which relieves pain and reduces inflammation, and metoclopramide, which accelerates the absorption of naproxen and contributes to the relief of migraine.
Dr. John R. Plachetka, chairman, president and CEO of POZEN stated, "The authorization for MT 100 by the MHRA is a milestone event for POZEN as it's our first regulatory approval for one of our drug candidates. We are currently seeking a partner who can bring MT 100 to market in the UK and eventually in other countries outside the US."
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 acute and chronic pain and pain-related therapeutic areas. POZEN has a development and commercialization alliance with GlaxoSmithKline. 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; 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 Quarterly Report on Form 10-Q for the quarterly period ended September 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.
SOURCE: POZEN, Inc.
POZEN, Inc. Bill Hodges, Chief Financial Officer, 919-913-1030 or Fran Barsky, Director, Investor Relations, 919-913-1044