Newron and Zambon enter into a new €5m agreement for safinamide

Zambon will make a total investment in Newron of €20m

Newron Pharmaceuticals has executed a €5m partnership and licensing deal for Newron’s leading compound safinamide, for the treatment of Parkinson’s disease.

Newron is an Italian research and development company focused on novel CNS and pain therapies based in Bresso, while Zambon is a chemical and pharmaceutical company with plants in Vicenza.

Zambon will make a total investment in Newron of €20m, which will also cover the completion of safinamide’s clinical development and the preparation of the application for marketing approval in Europe and the US.

In April Zambon made an investment of €5m in Newron equity and an option fee.

In addition, Zambon will pay Newron €5m for the agreement that has now been executed, covering the licence for safinamide research, development, manufacturing and marketing in all territories of the world, excluding those covered by a recently announced licensing agreement with Meiji Seika Pharma (Japan and key Asian territories).

Newron will receive significant success-based regulatory milestone payments as well as double-digit royalty payments on future sales of safinamide in the licensed territories.

Rolf Stahel, Newron’s chairman, said: ‘This strategic agreement with Zambon is of immense importance to Newron, as it provides us with a strong partner to support the completion of safinamide’s development. Additionally, the disclosed payments to Newron and the take-on of development costs by Zambon provides us with the means to broaden Newron’s strategic options.’

Roberto Consonni, Zambon Pharma’s ceo, added: ‘We believe the closing of the agreement on safinamide and our competences in the pharma area and in fine-chemical processes represents a significant opportunity in the add-on treatment of Parkinson’s disease.’

Phase III trials of safinamide are currently ongoing, with the firm reporting ‘positive results’ yesterday (14 May), which Newron says will lead to a projected global safinamide filing with the regulators in 2013.

Newron is also evaluating the further clinical development of ralfinamide for pain and psychiatric diseases.

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