Biovail entered into a license agreement with Kyowa Hakko Kirin for U.S. and Canadian rights to commercialize products containing istradefylline, a treatment for Parkinson disease. The firm paid an up-front fee of $10 million and could pay up to $20 million in milestones linked to development and FDA approval. Additionally, Kyowa could receive up to an additional $35 million if certain sales-based milestones are met.
Biovail will also make tiered, royalty payments of up to 30% on net commercial sales. In connection with this transaction, Biovail also entered into a supply agreement with Kyowa Hakko Kirin for the supply of istradefylline.
Istradefylline specifically antagonizes the adenosine A2A receptor, according to Biovail. Kyowa Hakko Kirin began clinical development in 1996 and conducted Phase II and Phase III trials in patients who were experiencing wearing-off phenomenon, a motor complication, while receiving Levodopa alone or in combination with other anti-Parkinson disease drugs. In April 2007, an NDA was submitted to the FDA, and in February 2008, Kyowa Hakko Kirin received an action letter from the FDA.
“This transaction again highlights our focus on late-stage specialty central nervous system products,” points out Bill Wells, Biovail’s CEO. “Istradefylline represents a novel approach for the treatment of Parkinson disease and provides another building block within our development pipeline, which now has four programs targeting unmet medical needs in Parkinson disease.”
Biovail’s pipeline comprises Staccato® loxapine for the treatment of agitation in schizophrenia and bipolar disorder patients; pimavanserin for Parkinson disease psychosis, as adjunctive therapy in schizophrenia, and potentially Alzheimer disease psychosis; BVF-018 (modified-release formulation of tetrabenazine) for the treatment of Tourette syndrome; fipamezole for levodopa-induced dyskinesia, also known as Parkinson disease dyskinesia; and CX717 for the treatment of respiratory depression.