Merck KGaA to Return Safinamide Rights to Newron Pharmaceuticals, Citing "Limited Market Potential"
Published: Oct 21, 2011
Based on the agreement signed in 2006, Merck Serono has confirmed that it will meet its contractual and ethical commitments regarding the ongoing clinical development program for safinamide until April 2012.
Based on the previously reported completion of enrolment of the Phase III MOTION and SETTLE trials, these studies are scheduled to report results in first half of next year. These two trials have been set up to complete the planned Phase III development of safinamide as an adjunctive treatment for Parkinson’s disease that was the basis for the registration programme agreed upon with health authorities in key world markets. Merck Serono will work with Newron to execute an appropriate transfer of the program to Newron.
The collaboration of Merck Serono and Newron on pruvanserin and sarizotan continues.
Newron will now re-assess all the opportunities for safinamide including re-partnering the compound at some stage. Ownership of global commercial rights for safinamide could provide Newron the option to pursue marketing of this new chemical entity for Parkinson's disease in selected territories, as well.
On 27 September Newron announced its intention to merge with Biotie Thera- peutics. Both companies will evaluate this new opportunity.
Further announcements will be made in due course.
Safinamide is an alpha-aminoamide that is currently being developed by Merck Serono and Newron as an add-on therapy to dopamine agonists or levodopa in patients with early or late- stage Parkinson’s disease. It is believed to have both dopaminergic and non-dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro. Studies are ongoing to better understand safinamide’s actions in patients with Parkinson’s disease.
About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Newron is undertaking phase III trials with safinamide for the treatment of Parkinson’s disease (PD) in conjunction with its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications. Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron’s additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection and NW-3509 for the treatment of schizophrenia. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.
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