Biovail Corporation 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 US 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 US$ 10 million, and could pay up to US$ 20 million in potential development milestones through US Food and Drug Administration (FDA) approval and up to an additional US$ 35 million if certain sales-based milestones are met. BLS will also make tiered, royalty payments of up to 30 per cent 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.
Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products.
Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan. It had a new start in October 2008 following the merger of Kyowa Hakko Kogyo and Kirin Pharma with the aim of becoming a global specialty pharmaceutical company that creates innovative new drugs.