|POZEN Confirms ANDA Filing for Treximet(R) Tablets|
CHAPEL HILL, N.C.--(BUSINESS WIRE)--
POZEN Inc. (NASDAQ: POZN), today announced that POZEN and GlaxoSmithKline (GSK), the holder of the New Drug Application for Treximet, received a letter from Par Pharmaceutical, Inc. (Par) notifying POZEN and GSK that Par submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market sumatriptan 85 mg/naproxen sodium 500 mg tablets, a generic version of the drug sold by GSK under the trade name, Treximet. Par's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of U.S. Patent Nos. 6,060,499, 6,586,458 and 7,332,183.
Par's letter also provided notice to POZEN and GSK that its ANDA contains a certification as required under 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act, commonly referred to as a "paragraph IV certification." Generally, such a certification states that the ANDA applicant believes that the claims of a patent to which a paragraph IV certification is made do not properly prevent that ANDA applicant from commercializing the product that is the subject of its ANDA. When an ANDA contains a paragraph IV certification, notice of that certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA (in this case, GSK) to which the ANDA refers.
GSK and POZEN are evaluating Par's letter and paragraph IV certification. POZEN has full confidence in its intellectual property portfolio related to Treximet and will vigorously defend its patents if they are infringed.
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. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet which was approved by the United States Food and Drug Administration for the acute treatment of migraine attacks, with or without aura, in adults, and with AstraZeneca for proprietary fixed dose combinations of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. 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, such as the current uncertainty regarding primary clinical endpoints for our PN and PA programs; 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, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet; 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 period ended June 30, 2008. 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.