In September 2006 Newron signed an agreement with Serono giving them exclusive worldwide rights to develop, manufacture and commercialise safinamide in Parkinson’s disease (PD), Alzheimer’s disease, and other cognitive disorders. For more details, see press releases.
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.