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Biovail gain Parkinson's drug rights

Biovail has entered into a licensing deal with Kyowa Hakko Kirin for the rights in the US and Canada for products containing istradefylline

Biovail, through its subsidiary Biovail Laboratories International, has entered into a licensing deal with Kyowa Hakko Kirin for the commercialisation rights in the US and Canada for products containing istradefylline – a chemical entity with the potential to treat Parkinson's disease.

The licensing agreement includes an upfront payment of $10m with the potential for a further $20m to be paid in milestone payments through approval from the US Food and Drug Administration (FDA). An additional $35m could also be paid should specific sales-based milestones be met.

Further royalty payments of up to 30 per cent will be made to Kyowa Hakko Kirrin on net commercial sales of products containing istradefylline.

"This transaction again highlights our focus on late-stage speciality central nervous system products," said Bill Wells, Biovail's CEO. 

"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 programmes targeting unmet medical needs in Parkinson's disease," he continued.

Kyowa Hakko Kirin began clinical trials of istradefylline in 1996. In April 2007, the new drug application (NDA) for registration of istradefylline in the US was submitted to 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.

3rd June 2010


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