Firm says decision results from pipeline review, and belief that safinamide has more limited market potential than originally envisaged.

Merck Serono will return its global rights to the Phase III-stage Parkinson disease candidate safinamide back to Newron Pharmaceuticals. The Merck KGaA division said its decision was made as part of an ongoing review of its R&D pipeline, together with its view that safinamide has a more limited market potential than originally anticipated. Newron stresses that Merck Serono’s move to offload safinamide isn’t due to any new efficacy or safety findings.

Newron is itself the subject of a €45 million takeover bid by Biotie Therapies. Although agreed by both firms’ boards, the transaction is still subject to the approval of Newron shareholders, at an EGM expected to be convened at the end of October. Biotie says it will now evaluate whether the situation regarding safinamide will have any impact on the proposed acquisition of Newron.

Transfer of the safinamide drug rights back to Newron will become effective in April 2012, until which Merck Serono will continue to meet all its contractual and ethical commitments regarding ongoing clinical development of the drug. The firm’s decision to pass safinamide back to Newron will also have no effect on the more recently signed deal granting Newron a license to develop Merck’s early clinical-stage serotonin and dopamine receptor modulators, pruvanserin and sarizotan, for potential CNS applications. Newron says it will now work to evaluate all the opportunities for safinamide’s continued development, including repartnering.

The firm granted Merck Serono exclusive worldwide rights to develop, manufacture, and commercialize safinamide for Parkinson disease, Alzheimer disease, and other cognitive disorders, back in 2006. The drug is in development for use in combination with dopamine agonists for the treatment of both early- and later-stage Parkinson disease, and has a multifactorial mechanism of action that includes reversible inhibition of MAO-B and of dopamine uptake, and inhibition of excessive glutamate release.

Merck Serono has completed patient enrollment into the Phase III Motion and Settle Studies, which are due to report during the first half on 2012, and represent the final trials in the planned Phase III development program for safinamide as an adjunctive therapy for Parkinson disease. 

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