HOUSTON, Dec. 28, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced that Mitsubishi Chemical Corporation, the patent holder for Argatroban injections, Mitsubishi Tanabe Pharma Corporation, Encysive and GlaxoSmithKline have filed a patent infringement lawsuit in the U.S. District Court for the Southern District of New York against Barr Laboratories, Inc. related to Argatroban injections. Argatroban is approved by the U.S. Food and Drug Administration (FDA) for the treatment of heparin-induced thrombocytopenia. Encysive is the holder of the New Drug Application for Argatroban, and has licensed the North American marketing rights for the drug to GlaxoSmithKline.
In November 2007, Encysive received a Paragraph IV Certification letter from Barr, notifying the company of the filing of an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Argatroban injections. Barr's ANDA seeks approval to market a generic version of Argatroban injections prior to the expiration of the patent covering the drug, U.S. patent no. 5,214,052, which is listed in the Orange Book with an expiration date of June 30, 2014. Barr contends that U.S. Patent No. 5,214,052, is invalid, unenforceable, and/or will not be infringed by Barr's manufacture, importation, use, or sale of the product for which the ANDA was submitted. Barr has lodged a contention with respect to obviousness, but provided no grounds for alleged unenforceability or noninfringement.
The commencement of this lawsuit against Barr will automatically stay, or bar, the FDA from approving Barr's ANDA for 30 months (unless modified by the Court), or until a final district court decision finding the patent invalid, unenforceable, or not infringed, whichever is earlier.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a global biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: www.encysive.com.
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This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are the uncertainties of U.S. patent infringement litigation; the validity of U.S. patent no. 5,214,052, the possibility that additional Argatroban ANDAs with Paragraph IV certifications will be filed with the FDA; the sufficiency of our existing capital resources to fund this patent infringement litigation, our ability to raise additional capital to fund cash requirements for future operations as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.