Biovail Corporation (NYSE, TSX: BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a license agreement with Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin). BLS has acquired the U.S. and Canadian rights to commercialize products containing istradefylline – a new chemical entity targeted for the treatment of Parkinson’s disease.
“This transaction again highlights our focus on late-stage specialty central nervous system products,” said Bill Wells, Biovail’s Chief Executive Officer. “Istradefylline represents a novel approach for the treatment of Parkinson’s disease and provides another building block within our development pipeline, which now has four programs targeting unmet medical needs in Parkinson’s disease.”
Under the terms of the agreement, BLS has paid an upfront fee of $10 million, and could pay 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. BLS will also make tiered, royalty payments of up to 30% on net commercial sales of products containing istradefylline. In connection with this transaction, BLS has also entered into a supply agreement with Kyowa Hakko Kirin 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.
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.