Date: 2017-05-12
Type of information: Milestone
Compound: safinamide
Company: Newron (Italy) Zambon (Italy)
Therapeutic area: Neurodegenerative diseases - CNS diseases
Type agreement: collaboration - licensing
Action mechanism: Monoamine oxidase inhibitor. Safinamide is an alpha-aminoamide. It has a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of excessive release of glutamate.
Disease: Parkinson's disease
Details:
- • On April 5, 2012, Newron Pharmaceuticals has signed a strategic collaboration and licence option with Zambon Company, the industrial holding of Zambon, for Newron’s lead compound safinamide. The compound is currently in phase III development as an add-on therapy to dopamine agonists and levodopa in patients with Parkinson’s disease. The global rights to safinamide will be returned to Newron by Merck Serono on April 17, 2012. Last october, Newron Pharmaceuticals has announced that Merck Serono,was returning global rights to safinamide to Newron effective due to strategic considerations and re-prioritization of its R&D pipeline.
Financial terms:
- Under the agreement, Zambon will make an initial investment of €20m into Newron also covering the completion of safinamide’s clinical development and the preparation of the application for marketing approval in Europe and the US. Zambon will make an immediate equity investment in Newron of 726,435 newly issued shares at market price for a fully diluted 9.1% shareholding. Zambon has also committed to increase its stake in Newron in a future share capital increase.
- In addition, Zambon will pay Newron an undisclosed sum for the exclusive option to a license for safinamide covering its research, development, manufacturing and marketing in all territories of the world with the exclusion of those covered by the license agreement with Meiji Seika Pharma (Japan and key Asian territories).
Latest news:
- • On May 12, 2017, Newron Pharmaceuticals announced the receipt of milestone payments linked to the approval of Xadago® (safinamide) for the treatment of Parkinson’s disease by the FDA. The payments were made by Newron’s partner Zambon, who holds the rights to develop and commercialize Xadago® globally, excluding Japan and other key territories where Payments totaled €11.3 million which under the applicable IFRS rules will be recognized as immediate revenue. Newron is also eligible to receive royalty payments on sales as part of the 2012 agreement.
- • On May 14, 2012, Newron has announced that it has executed with Zambon a strategic collaboration and licence agreement for safinamide.
- • On May 2, 2012, Newron announced that it has agreed with Zambon to extend the option term for a strategic collaboration and licence for Newron’s lead compound safinamide to May 13, 2012.
Is general: Yes
