Newron & Zambon Enter Strategic Collaboration & License Agreement

Newron Pharmaceuticals S.p.A. recently announced it has executed with Zambon a strategic collaboration and license agreement for Newron’s lead compound safinamide. In aggregate, the total Zambon investment in Newron will be $25.5 million as defined further, also covering the completion of safinamide’s clinical development and the preparation of the application for marketing approval in Europe and the US.

Zambon has already made an investment of $6.38 million in Newron equity and an option fee, which was announced on April 5, 2012. In addition, Zambon will make a down payment to Newron of $6.38 million for the agreement that has now been executed, 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 US. Zambon qualifies for one seat on the board of directors of Newron, at the upcoming Annual General Meeting.

Newron will receive significant success-based regulatory milestone payments as well as customary double-digit royalty payments on future sales of safinamide in the 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, Newron’s Chairman. “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.”

“Zambon has always been strongly committed to improve the Quality of Life of patients and bring innovative treatments to the market,” added Roberto Consonni, Zambon Pharma’s CEO. “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.”

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson’s disease (PD). Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron’s additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection, NW-3509 for the treatment of schizophrenia, as well as pruvanserin and sarizotan for treatment of CNS diseases. Newron is headquartered in Bresso, near Milan, Italy. For more information, visit www.newron.com.

Zambon is an Italian pharmaceutical and fine-chemical multinational company, earning a strong reputation over the years for high-quality products and services. Zambon was established in 1906 in Vicenza, where are based the Italian fine-chemical and pharma plants. The other manufacturing units are in Switzerland, France, China, and Brazil. Zambon is present in 15 countries with more than 2,500 employees. Zambon Company S.p.A. is the industrial holding of the group, with Zach (Zambon Chemicals), which is a preferred partner for API, custom synthesis, and generics products for big pharma companies; with Zambon S.p.A., the pharma business, which mainly operates in respiratory, pain, and women healthcare; with Z-Cube, the corporate research venture, scouting new technologies and drug delivery system opportunities. For more information, visit www.zamboncompany.com.