Serono and Newron Pharmaceuticals signed an agreement under which Newron has granted Serono exclusive worldwide rights to develop, manufacture and commercialise safinamide in Parkinson's disease (PD), Alzheimer's disease, and other cognitive disorders. Newron has recently reported positive results with safinamide from an early phase III study in Parkinson's disease.
Under the terms of the agreement, 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 details of the financial terms of the agreement were not disclosed.
Safinamide is an alpha-aminoamide derivative which is orally administered. Studies have shown that safinamide combines the inhibition of dopamine re-uptake and MAO-B, two key mechanisms involved in the control of dopamine concentration in the brain, and inhibition of glutamate release. Based on the results of prior clinical trials, Newron believes that safinamide, as an adjunctive treatment to dopamine agonists and levodopa, has a competitive advantage over current therapies for Parkinson's disease.
Luca Benatti, CEO of Newron, said, "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."
Franck Latrille, senior executive vice president of Global Product Development, Serono, commented, "This partnership enables us to expand our Neurology portfolio by investing in innovative products to meet significant unmet medical needs, such as Parkinson's and Alzheimer's disease."
Safinamide will be the subject of an extensive clinical development plan undertaken by both companies, with Serono assuming overall leadership of the programme. This will involve Newron completing on-going phase III studies with safinamide as an add-on therapy to dopamine agonists in early stage PD patients, and with safinamide as an adjunct treatment to Levodopa in mid to late stage PD patients. Serono plans to expand the programme with a series of innovative additional studies aimed at addressing unmet medical needs in the treatment of Parkinson's disease, such as control of non motor symptoms, mainly cognitive impairment and depression, the delay and severity of motor complications and the possibility to delay disease progression.
The double blind placebo controlled trial, conducted in Europe, South America and Asia with 270 early stage Parkinson's disease patients being treated with safinamide as an adjunctive treatment to a stable dose of a single dopamine agonist, proved over 24 weeks of treatment to be well tolerated and associated with a clinically relevant and statistically significant improvement in UPDRS part III motor score (primary efficacy measure) as well as several secondary endpoints such as responder rates and Activities of Daily Living (ADL) compared to dopamine agonist monotherapy, at a dose of 50 to 100 mg/day. In addition, safinamide showed promising effects on cognition. Compared to patients on dopamine agonist monotherapy, the addition of safinamide indicated a potential improvement in cognitive function.
Unified Parkinson's Disease Rating Scale (UPDRS) III motor scale, which provides a semi quantitative evaluation of motor impairment as a means of rating patients severity.