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Oct18
Serono and Newron Pharma Entered Into Global Development and Commercialization Agreement for Safinamide

Serono (VTX: SEO and NYSE: SRA) and Newron Pharmaceuticals SpA has entered into an agreement wherein Newron has granted Serono the exclusive worldwide rights for the development, manufacture and commercialization of safinamide in Parkinson's disease (PD), Alzheimer's disease, and other cognitive disorders.

Safinamide has recently revealed positive clinical results from an early Phase III study in Parkinson’s disease. Safinamide is an orally administered alpha-aminoamide derivative that combines the inhibition of dopamine re-uptake and MAO-B: the two key mechanisms involved in the control of dopamine concentration in the brain, and inhibition of glutamate release.

The terms of agreement include:

  • Serono will be responsible for all future development, manufacture and commercialisation costs.
  • Serono will make an upfront payment and additional milestone payments to Newron of up to $200 million based on defined development and commercialization achievements in all major markets.
  • Serono will also pay Newron undisclosed royalties on worldwide net sales.
  • In addition, Newron will have the right to opt for co-promotion with Serono in Italy and Spain. Other financial details of the agreement were not disclosed.
  • According to Luca Benatti, CEO of Newron:

    "Serono has a major presence in the area of CNS and is the right partner to take safinamide on at this late-stage in its development.

    The significant financial contribution from Serono, together with the co-promotion opportunity, will enable us to further develop Newron as a broader based fully integrated bio-pharmaceutical company."

    Under the agreement, Safinamide will the be the subject of an extensive clinical development plan undertaken by both companies, with Serono assuming overall program leadership.

    Find more details from the press release (a pdf file). 

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