Santhera and Biovail Enter into License Agreement to Develop and Commercialize JP-1730/Fipamezole in North America
Santhera Pharmaceuticals and Biovail Corporation announced that the two companies have signed a license agreement for Santhera's JP-1730/fipamezole. Biovail acquires the US and Canadian rights to develop and commercialize the drug for the treatment of dyskinesia in Parkinson's disease. JP-1730/ fipamezole is a first-in-class compound that, in a recent Phase IIb study, displayed the potential to reduce levodopa-induced dyskinesia.
Under the terms of the agreement between Biovail Laboratories International SRL and Santhera Pharmaceuticals Ltd and subject to customary closing conditions, Santhera will receive an upfront payment of USD 8 million and a further payment of USD 4 million upon the successful closing of its acquisition of Oy Juvantia Pharma Ltd. Biovail will pay up to USD 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 Parkinson's Disease. The agreement also stipulates that Biovail make additional milestone payments of up to USD 145 million as certain sales thresholds are met. Santhera will also receive royalty payments of 8% to 15% on net commercial sales of JP-1730/fipamezole. Should Biovail pursue a second indication, up to USD 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 United States 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 United States is scheduled for 2011. Santhera will retain co-promotion rights in the United States.
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