Newron’s aim is to build a leading Central Nervous System (CNS) development company. Our global growth strategy has three elements, centered around developing innovative therapies for CNS disorders, with a special focus on drugs for rare diseases (Orphan Drugs).
1. Maximize safinamide’s commercial opportunity
Through our partnerships with Zambon and Meiji Seika Pharma, we are working to maximize the opportunity for safinamide, which as the first add on therapy to treat early and mid-late stage Parkinson’s disease has the potential to improve the lives of patients around the world. Following the submission of the Marketing Authorization Application (MAA) for safinamide for the treatment of Parkinson’s disease to the European Medicines Agency (EMA) in December 2013, to Swissmedic in March, 2014 as well as the New Drug Application NDA to the US FDA, Newron is working towards global approval of the compound, together with its partners. We are supporting Meiji Seika Pharma in the clinical development of the product in Japan.
2. Focus development resources on value-creation
To maximize the value of our pipeline, we are utilising our development resources on our portfolio of orphan drug candidates, (sarizotan, ralfinamide). Developing orphan drug candidates matches best the Company's financial and organisational resources, and given the advantages, including speed to market, lower development costs and regulatory hurdles as well as higher pricing, allows us to generate substantial benefit for patients suffering from the diseases and our shareholders.
3. Out licence or monetize non-core assets
Partnering is an important part of our overall strategy and we are actively talking to potential partners about our innovative pipeline of novel compounds, to ensure these compounds are profiting from the best expertise to bring them to market.