June 3, 2010
Kyowa Hakko Kirin to enter out-licensing agreement with Biovail for
anti-Parkinson's disease drug KW-6002 (Istradefylline) in North America
Tokyo, June 3, 2010 –Today, Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) Chiyoda-ku, Tokyo Japan; President, Yuzuru Matsuda) has formed a licensing agreement with Biovail Laboratories International SRL (BLS), a subsidiary of Biovail Corporation (Ontario, Canada; CEO, Bill Wells) for the development and commercialization of Kyowa Hakko Kirin’s anti-Parkinson's disease drug KW-6002 (generic name: Istradefylline) in the U.S. and Canada.
Under the terms of the agreement, Kyowa Hakko Kirin will receive from BLS an upfront fee of $10 million, and could receive up to $20 million in potential development milestones through U.S. Food and Drug Administration (FDA) approval and up to an additional $35 million if certain sales-based milestones are met. Kyowa Hakko Kirin will receive tiered, royalty payments of up to 30% on net commercial sales of products containing istradefylline. In connection with this transaction, Kyowa Hakko Kirin has also entered into a supply agreement with BLS for the supply of istradefylline.
BLS will be seeking a meeting with the FDA in the near term to discuss istradefylline’s development path forward.
･About Biovail Corporation:
Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products. The Company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system markets. The Company is listed on the New York Stock Exchange and the Toronto Stock Exchange.
･About KW-6002 (Istradefylline):
Istradefylline has a novel mechanism of action that specifically antagonizes the adenosine A2A receptor. Kyowa Hakko Kirin began clinical trials of istradefylline in 1996 and conducted Phase II and Phase III trials to assess and identify its safety and efficacy in Parkinson's disease patients who were experiencing wearing-off phenomenon, a motor complication, while receiving Levodopa therapy alone or in combination with other anti-Parkinson's disease drugs. In April 2007, based on the results of these studies, the new drug application (NDA) for registration of istradefylline in the U.S. was submitted to the FDA and on February 25, 2008, Kyowa Hakko Kirin received an action letter from the FDA. The results of the Phase II clinical trial in Japan demonstrated the efficacy of istradefylline compared to placebo and Kyowa Hakko Kirin is currently conducting a Phase III clinical trial in Japan.
･About Parkinson’s disease:
Parkinson's disease is a progressive neurodegenerative disorder which is 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 certain nerve cells located in a specific area in the brain leading to a shortage of the neurotransmitter dopamine. This results in decreased activation of dopamine receptors in the brain which is thought to cause the motor symptoms. The symptoms of Parkinson's disease are treated primarily by dopamine replacement therapy with Levodopa or dopamine agonists. Long-term therapy with Levodopa is associated with motor complications such as the development of a shortening response to each dose, which is called "wearing-off phenomenon", and involuntary movements.