June 3, 2011
Termination of the North American licensing agreement for KW-6002 (Istradefylline)
Tokyo, Japan, June 3 2011 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that the licensing agreement for the right of KW-6002 (generic name: Istradefylline) for North America with Valeant International (Barbados) SRL ("Valeant"), a subsidiary of Valeant Pharmaceuticals International, Inc. (formerly Biovail Corporation), has been terminated in June 2, 2011.
Background and details
|1.||On June 3, 2010, Kyowa Hakko Kirin licensed to Valeant, then called Biovail Laboratories International SRL, the commercialization rights of KW-6002 for North America, which was being developed for the indication of anti-Parkinson's disease.
|2.||In September 2010, Biovail Corporation merged with Valeant Pharmaceuticals International, and changed its name to Valeant Pharmaceuticals International, Inc. ("VPII"). Following the merger, Valeant and VPII adopted a new research and development model and began identifying product development programs that did not align with this new R&D model. It is in connection with this new R&D model that Valeant has made the decision to terminate the current licensing agreement.
|3.||As a result of this termination, all rights of KW-6002 relating to North America have reverted to Kyowa Hakko Kirin.|
About KW-6002 (Istradefylline)
KW-6002 has a novel mechanism of action that antagonizes adenosine A2A-receptors. Clinical studies on KW-6002 have been conducted to evaluate its efficacy and safety in Parkinson's disease patients who had motor complication, such as wearing-off phenomena on levodopa therapy alone or in combination with other anti-Parkinson's disease agents. In April 2007, a new drug application was submitted to the US-FDA, and on February 25, 2008 (US time), an Action Letter, that is, a notification of review status, was received from the FDA. In Japan, the Phase-III clinical studies were completed, and the mean daily duration of the off state was shown to be statistically significantly reduced, compared with placebo group. In addition, with respect to safety, the tolerability of the product was demonstrated.
About Parkinson's disease
Parkinson's disease is a condition of progressive neuronal degeneration, characterized by motor symptoms such as slowness of movement, rigidity, tremor and postural instability. The symptoms of this disease result from the progressive degeneration of the part of the central nervous system made up by the substantia nigra and striatum, resulting in cerebral dopamine deficiency. There are approximately 150,000 Parkinson's disease patients in Japan.
About Valeant Pharmaceuticals International, Inc.
|Location of Head Office:Ontario, Canada|
|CEO:J. Michael Pearson|
|Number of employees:approx. 4300|
|Business details:||Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics|