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Santhera and Juvantia to Collaborate on Development of Phase II Product for Dyskinesia in Parkinson's Disease
07 Sep 2006 -
Santhera Pharmaceuticals and Juvantia Pharma announced that they have entered into a strategic collaboration to advance the development of Juvantia's fipamezole (JP-1730) for the treatment of Dyskinesia in Parkinson's Disease (DPD) patients. A Phase IIa clinical trial in the US has already shown proof-of-concept for fipamezole and a fast track registration status has been granted by the FDA.
The collaboration is aimed at advancing fipamezole through a larger-scale Phase IIb clinical trial next year to confirm the encouraging results seen in the earlier Phase IIa clinical trial. Santhera will be responsible for conducting and funding development work and has a call option to secure all rights to the product via the acquisition of all Juvantia shares at a later point in time. No further financial terms of the agreement were disclosed.
Dr. Juha-Matti Savola, former CEO and President of Juvantia, has joined Santhera as Director Clinical Development and will be responsible for the fipamezole development program at Santhera's facilities in Liestal, Switzerland.
Fipamezole, an alpha-2 adrenergic receptor antagonist, offers a novel mode of action to treat dyskinesia (involuntary movements) in Parkinson's Disease (PD). In a Phase IIa clinical trial, carried out in collaboration with the US National Institutes of Health (NIH), fipamezole was able to reduce levodopa-induced dyskinesias and prolong levodopa's duration of action. Levodopa is currently the standard therapy for PD and can result in patients developing dyskinesia after several years of its use. The Phase IIa results have established proof-of-concept for fipamezole.
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