Santhera Signs License Agreement With Biovail

Santhera and Biovail have signed a license agreement for Santhera’s JP-1730/fipamezole. Biovail has acquired the US and Canadian rights to develop and commercialise the drug for the treatment of Dyskinesia in Parkinson’s Disease.

Under the terms of the agreement, Santhera will receive an upfront payment of $8m and a further payment of $4m upon the successful closing of its acquisition of Oy Juvantia Pharma.

Moreover, Biovail will pay up to $35m in potential development and regulatory milestones associated with the initiation of a phase III study, regulatory submissions and approvals of JP-1730/fipamezole in Dyskinesia Parkinson’s Disease.

Additionally, the agreement also stipulates that Biovail make additional milestone payments of up to $145m, as certain sales thresholds are met. Santhera will also receive royalty payments of 8% to 15% on net commercial sales of JP-1730/fipamezole.

Biovail will be responsible for the remaining clinical development programs and costs in the US and Canada. The companies have agreed to collaborate on the development program.

Santhera will have the right to use and sublicense data generated for development and commercialisation purposes outside of North America. Initiation of the first phase III study in the US is scheduled for 2011. Santhera will retain co-promotion rights in the US.

Klaus Schollmeier, CEO of Santhera, said: “Importantly, today’s agreement is consistent with our strategy of partnering larger indications whilst retaining copromotional rights for our commercial operations in the US.