Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it, its affiliate Sucampo AG, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited (Takeda), and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Inc., Par Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. (collectively, Anchen) related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA ® (lubiprostone) oral capsules, 8 mcg and 24 mcg. The lawsuit claims infringement of six patents that are listed in the FDA’s Orange Book and that are scheduled to expire between 2020 and 2027.
Sucampo commenced the lawsuit within 45 days from the receipt of a Notice letter sent by Anchen, dated December 26, 2012, regarding its filing of its ANDA. Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit, final FDA approval of Anchen’s ANDA will be stayed up to 30 months from the January 2, 2013 date of receipt of the Notice letter.
“Sucampo’s patent estate for AMITIZA ® is strong, and the company intends to vigorously defend our intellectual property. We believe that the AMITIZA ® patents, granted by the US Patent & Trademark Office, are valid, enforceable, and infringed by Anchen’s proposed lubiprostone products,” said Thomas J. Knapp, Executive Vice President, Chief Legal Officer, and Corporate Secretary of Sucampo.
About Sucampo Pharmaceuticals, Inc.Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman, Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com. Sucampo Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the US and internationally and the exposure to litigation and/or regulatory actions. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's most recent Form 8-K and 10-K, which the Company incorporates by reference.
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