Zambon, an Italian chemical and pharmaceutical company, has formed a strategic collaboration and license agreement with Newron Pharmaceuticals, an R&D company focused on novel CNS and pain therapies, for the latter’s lead compound safinamide.
The Zambon investment in Newron will total approximately $25.4 million, also covering the completion of safinamide's clinical development and the preparation of the application for marketing approval in Europe and the U.S.
Zambon already made an investment of $6.3 million in Newron equity and an option fee in April, 2012. In addition, Zambon will make a down payment to Newron of an addition $6.3 million, covering the license for safinamide research, development, manufacturing and marketing in all territories of the world with the exclusion of those covered by the recently announced license agreement with Meiji Seika Pharma (Japan and key Asian territories). Furthermore, Zambon will meet the costs incurred by Newron to complete the development of safinamide and prepare the applications and file for marketing approval in Europe and the U.S. Zambon qualifies for one seat on the board of directors of Newron, at the upcoming annual general meeting.
Newron will receive milestone payments based on significant regulatory success, as well as customary double-digit royalty payments on future sales of safinamide in licensed territories.
"The 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,” said Rolf Stahel, chairman of Newron. “Additionally, the disclosed payments to Newron and the take-on of development cost by Zambon provides us with the means to broaden Newron´s strategic options."
Roberto Consonni, CEO of Zambon, 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."