Fipamezole for treatment of levodopa (L-dopa) induced Dyskinesia in Parkinsonís Disease; Expected USD 700m+ peak sales first-in-class opportunity for US and EU ready to enter Phase III
Fipamezole is an antagonist of the adrenergic alpha-2 receptor with a novel mode of action in the treatment of Dyskinesia in Parkinson's Disease. The rationale behind the development of fipamezole is to increase noradrenergic release in certain areas of the brain, resulting in rebalancing of the distorted brain network and potentially alleviating symptoms of advanced Parkinson's disease such as dyskinesia, motor fluctuations, orthostatic hypotension and cognitive impairment without exacerbating the underlying Parkinsonian features of the disease.
After positive results of a Phase II study in the treatment of levodopa (L-dopa) induced Dyskinesia in Parkinsonís Disease, Santhera is intending to build a partnership for further development and commercialization of fipamezole. A future licensee will develop and commercialize the product, will have the right to use all data generated by Santhera for development and commercialization and may license worldwide rights, but territory of interest to be negotiated.
Santhera has EU patent protection for the intended oromucosal formulation until 2023. The program, which was granted fast track designation status by the US Food and Drug Administration, is available for partnering.
Rudolf Hausmann, Ph.D.
Phone: +41 78 827 5107