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Under the terms of the agreement, which covers only the US and Canada, and subject to customary closing conditions, Biovail will make an upfront payment of $8 million, a further payment of $4 million upon the successful closing of Santhera's acquisition of Oy Juvantia Pharma, and will pay up to $35 million 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 in Parkinson's disease.
The agreement also stipulates that Biovail make additional milestone payments of up to $145 million as certain sales thresholds are met. Biovail will also make royalty payments of 8% to 15% on net commercial sales of JP-1730/fipamezole. Should Biovail pursue a second indication, up to $20 million in additional success milestones would be payable to Santhera upon approval.
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 commercialization 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.
Bill Wells, Biovail's CEO, said: "This agreement with Santhera is directly on strategy and another important step in our efforts to build a sustainable product-development pipeline in specialty central nervous system disorders."
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