Santhera Pharmaceuticals received €13 million (about $16.58 million) from Ipsen under a potentially €141 million (about $179.75 million) deal granting the latter rights to fipamezole outside the U.S., Canada, and Japan. The compound is being developed as a treatment for levodopa-induced dyskinesia in Parkinson disease.
While Santhera holds Japanese rights, Biovail owns the drug in the U.S. and Canada. Biovail expects to begin the Phase III program for fipamezole in 2011. Santhera’s agreement with Ipsen stipulates that Ipsen has the right to use the resulting data for its own development and commercialization purposes within its licensed territories.
Additional payments contingent to future development, regulatory, and sales milestones of up to €128 million have also been agreed to. In addition, Santhera is entitled to royalty payments on Ipsen’s future net sales.
Fipamezole is an antagonist of the adrenergic alpha-2 receptor that reportedly has a novel mode of action in the treatment of dyskinesia in Parkinson disease. The rationale behind development is to increase noradrenergic release in certain areas of the brain resulting in rebalancing of the brain network and potentially alleviating symptoms of advanced Parkinson disease, such as dyskinesia and motor fluctuations, without exacerbating the underlying Parkinsonian features of the disease.