Sucampo Pharmaceuticals, Inc. ("Sucampo") announced that it, together with R-Tech Ueno, Ltd., Sucampo AG, and Takeda Pharmaceutical Company Limited ("Takeda") and certain affiliates of Takeda, has filed a patent infringement lawsuit against Anchen Pharmaceuticals, Inc. ("Anchen"), which had filed Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA® (lubiprostone) oral capsules, and certain affiliates of Anchen. (For more details, please refer to Sucampo's release dated February 8, 2013)
As a result of Sucampo's filing of the said lawsuit, final FDA approval of Anchen's ANDA will be stayed up to 30 months from January 2, 2013.
The said filing will have no impact on the forecast of business results for the fiscal year ending March 2013.
About R-Tech Ueno, Ltd.
R-Tech Ueno is a bio venture company established in September 1989 for
the purpose of R&D and marketing of drugs. Under the leadership of the
CEO, also a medical doctor, the company is developing new drugs on the
theme "Physician-Oriented New Drug Innovation", targeting ophthalmologic
and dermatologic diseases that previously had no effective therapeutic
We aim at becoming a "global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) and developing and selling pharmaceutical products through the eyes of doctors." We are promoting the development of new drugs for unmet medical needs for which the government provides recommendations and assistance, orphan drugs and the drugs in the field of anti-aging (lifestyle drugs).
Lubiprostone (trade named Amitiza®) is a local activator of type-2 chloride channels in cells lining the small intestine. Lubiprostone increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. Sucampo management believes the type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body.
Amitiza® is a registered trademark of Sucampo Pharmaceuticals, Inc.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., an international pharmaceutical company,
is focused on the discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of
prostones, which occur naturally in the human body as a result of
enzymatic, 15-PGDH, transformation of certain fatty acids, was first
identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals'
Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo
Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief
Executive Officer and currently Advisor, International Business
Development and a member of the Board of Directors.
For more information about Sucampo Pharmaceuticals, please visit www.sucampo.com.