|POZEN Receives Positive News on MT 100 in the U.K.|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jan. 26, 2005--POZEN Inc. (NASDAQ: POZN) announced today that it has received a letter from the Committee on Safety of Medicines (CSM), the Advisory Group to the United Kingdom's (UK) Medicines and Healthcare Products Regulatory Agency (MHRA), agreeing to advise the MHRA that a marketing authorization be granted for MT 100 in the UK, provided that POZEN supplies additional information and meets certain conditions outlined in the letter. Although the MHRA is not bound by the CSM's recommendation, POZEN believes that the MHRA typically agrees with the CSM's opinions. POZEN believes that it can provide the additional information and address all of the conditions set forth in the letter and plans to respond to the letter within 30 days.
If UK approval is granted unconditionally by the MHRA, POZEN will seek approval in Denmark, Sweden, Norway and Finland through the European Union Mutual Recognition Procedure (MRP), in order to enable its licensing partner Nycomed to commercialize MT 100 in those countries. POZEN will also be seeking a partner to market MT 100 in other key European countries to be included in the MRP.
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 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.
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, including because of restrictive conditions to its use or sale; our failure to fully satisfy the conditions to approval of a product candidate or to obtain approval in countries in which we hope to commercialize a product candidate; the failure to obtain approval of our product candidates, including because of, among other reasons, the judgment of the FDA or the regulatory authority in a foreign country that the benefits of the drug do not outweigh its risks and differences in the interpretation of the FDA or another regulatory authority of the results of studies or trials from that of POZEN; costs and delays in the development and/or approval of our product candidates in the United States or other countries, 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 delays in the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue under our collaborative agreements or our failure to achieve milestones under such agreements 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, 2004 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 HodgesChief Financial Officer 919-913-1030 Fran Barsky Director, Investor Relations 919-913-1044
SOURCE: POZEN Inc.