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Biovail exits Parkinson's collaboration

Biovail is returning the rights to a late-stage Parkinson's disease drug candidate to the Swiss firm Santhera Pharmaceuticals

Biovail, which was recently acquired by Valeant Pharmaceuticals, is returning the rights to a late-stage Parkinson's disease drug candidate to the Swiss firm Santhera Pharmaceuticals.

Santhera said it will regain the US and Canadian rights to the drug, known as fipamezole, in January 2011. The drug is poised to enter phase III studies for the treatment of levodopa-induced dyskinesia in Parkinson's Disease, a debilitating movement disorder for which there is currently not an approved treatment in the US.

Santhera and Biovail signed a development and commercialisation deal in August of last year under which Biovail made a $12m payment to the Swiss firm.

However, according to Santhera, Biovail has determined as part of its post-merger review that the drug is no longer a strategic priority for the company.

"Biovail has decided to return the fipamezole project solely due to a shift in strategic focus of the new Valeant group," the company said.

"Importantly, the programme has advanced significantly over the past year, including technical process optimisation for supply of product and the completion of important nonclinical and clinical studies, which were all performed by Biovail."

Santhera said it is committed to completing the phase III development programme for the North American markets. The company said it would discuss next steps with the French pharmaceutical company Ipsen, which recently licensed the drug outside North America and Japan.

Fipamezole was shown in phase II studies to reduce levodopa-induced dyskinesia without a clinically meaningful worsening of Parkinson-type features of the disease. The data also suggest that the drug may improve cognitive functioning. 

25th October 2010

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