Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson’s Disease Patients
15.3.2021 09:00:00 EET | Business Wire | Press release
Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system and its partner, Zambon S.p.A. (“Zambon”), an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, today announced an agreement regarding a potentially pivotal study to evaluate the efficacy of safinamide in Parkinson’s disease patients with levodopa induced dyskinesia (PD LID).
Under the agreement, Newron will sponsor the study and be responsible for its development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.
The double-blind, placebo-controlled study is intended to be performed in the US, Europe and Asia/Australia, with the aim of a label extension for safinamide in key markets. Safinamide has previously been approved for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa experiencing “off” episodes in 20 markets including: the European Union, Switzerland, the United Kingdom, the United States, Canada, Australia, Latin America, Israel, the United Arab Emirates, Japan and South Korea. Safinamide is commercialized by Zambon as well as Meiji Seika/Eisai. Supernus Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of products for the treatment of CNS diseases, acquired the US commercialization rights for safinamide in 2020.
Ravi Anand, CMO of Newron, said: “Previous pre-clinical and clinical studies have provided preliminary evidence of the efficacy of safinamide in reducing dyskinesia. We will be working with international clinical experts and regulatory authorities to finalize the design of a global trial to demonstrate the benefits of safinamide on dyskinesia in patients with PD.”
Paola Castellani, CMO and R&D Head of Zambon, added: “Since 2015, thousands of Parkinson’s disease patients around the world have benefited from safinamide’s safe and efficacious profile and the subsequent improvement in their motor fluctuations. We look forward to working closely with Newron to potentially provide a new treatment option for those living with PD LID, an area of huge medical need.”
Parkinson’s disease affects an estimated seven to ten million patients worldwide. More than 40% of Parkinson patients experience PD LID, involuntary, non-rhythmic and often painful movements during waking hours that are purposeless and unpredictable. Dyskinesia can interfere with people's daily living, resulting in functional impairment and disability. People with Parkinson's disease often experience multiple fluctuating periods of OFF time and dyskinesia during any given day, which can impede their movement and daily function. Currently, only one drug has ever received marketing authorization for PD LID in the US.
References:
Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. Borgohain, Rupam; Szasz, Jozsef; Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H et al. (2014)
Movement disorders : official journal of the Movement Disorder Society vol. 29 (10) p. 1273-80.
Anand R: Safinamide is associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa (SETTLE). 17th International Congress of Parkinson’s Disease and Movement Disorders, Sydney, Australia, June 16-20, 2013.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210314005022/en/
Contact information
Newron
Stefan Weber - CEO
+39 02 6103 46 26 - pr@newron.com
UK/Europe: Simon Conway / Natalie Garland-Collins
FTI Consulting
+44 20 3727 1000 - SCnewron@fticonsulting.com
Switzerland: Valentin Handschin, IRF Reputation
+41 43 244 81 54 - handschin@irf-reputation.ch
Germany/Europe: Anne Hennecke, MC Services
+49 211 52925222 - anne.hennecke@mc-services.eu
USA: Paul Sagan, LaVoieHealthScience
+1 617 374 8800, Ext. 112 - psagan@lavoiehealthscience.com
Zambon
Valentina Saffioti - Global Pharma Communication
+39 0266524508 - valentina.saffioti@zambongroup.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Airship Announces Results Guarantee; Releases Commissioned Study Finding 476% ROI for Composite Organization22.7.2026 18:00:00 EEST | Press release
Airship, the mobile-first customer experience platform leader, today announced its Airship Results Guarantee, a corporate commitment to achieve predetermined business outcomes for new customers. Concurrently, the company released the results of a separate, commissioned Total Economic Impact™ (TEI) study conducted by Forrester Consulting on behalf of Airship, July 2026. The study found that a composite organization based on interviewed customers achieved a 476% Return on Investment (ROI) with a payback period of less than six months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722832535/en/ Airship has launched a new results guarantee offer to stand behind its value. Alongside this offer, the team shared the results of a new Total Economic Impact™ (TEI) study commissioned with Forrester Consulting illustrating that a composite organization achieved a 476% ROI with a payback period of less than six months. “We introduced
Arrakis Comes out of Stealth With $38M to Help Industrial Enterprises Compete in the AI Era22.7.2026 16:56:00 EEST | Press release
Arrakis, the AI deployment company helping industrial companies install AI agents for mission-critical operations, today announced a $30 million Series A led by Blossom Capital, with participation from existing investor Accel, which also led the company's $7.5 million seed round. The round brings total funding to around $38 million and includes backing from prominent technology leaders, including Olivier Pomel, founder and chief executive of Datadog, Olivier Godement, OpenAI’s Head of business products and Junaid Hussein, founder of Cambridge Aerospace. Founded in January 2026 by former Accel investor Rafael Quintanilla, together with co-founders Haroun Beltaifa, Romain Fouilland and Mikhail Galkov - alumni of Palantir, DeliveryHero, Revolut, Datadog and ASML - Arrakis helps industrial companies deploy AI into core operational workflows across aerospace, energy, logistics, manufacturing, construction and telecommunications markets. Across the US and Europe, governments and businesses a
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 16:00:00 EEST | Press release
Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Sentinel satellites to create detailed embeddings - compressed AI representations - of every 10-meter square of Earth's surface. TESSERA represents the most accurat
Omilia Appoints Ryan Kam as Chief Marketing Officer to Lead Global Brand and Growth Strategy22.7.2026 15:00:00 EEST | Press release
Omilia, a global leader in Self-Learning Agentic CX, today announced the appointment of Ryan Kam as Chief Marketing Officer (CMO). Ryan will be responsible for Omilia's global brand, demand generation, and marketing strategy as the company scales its go-to-market presence across enterprise markets. In his new role, Kam will own Omilia's global marketing function, spanning brand strategy, demand generation, product marketing, analyst relations and communications. He joins at a moment of significant commercial momentum: Omilia has seen accelerating enterprise demand across all industries and is investing in a marketing engine built to match the pace of its growth. Ryan Kam brings more than 20 years of marketing leadership across some of the most recognized names in enterprise technology. Most recently, he served as CMO at Egnyte, a leader in cloud content security and governance. Prior to that, Kam held the CMO role at LogicMonitor, where he drove growth for one of the leading infrastruc
Echodyne Announces ATAK Integration for MESA® Radar Platform22.7.2026 15:00:00 EEST | Press release
Echodyne, the radar platform company, today announced the availability of an Android Team Awareness Kit (ATAK) plugin for its MESA® radar platform. The integration enables users to configure, control, and visualize data from Echodyne radars within the ATAK environment, supporting military, public safety, and security operations that rely on TAK for shared situational awareness. The plugin extends radar management and visualization capabilities to ATAK users, allowing high-fidelity radar data and system controls to be accessed through a familiar operational interface. By integrating radar data into existing TAK workflows, organizations can streamline deployment, reduce operator workload, and improve access to real-time situational awareness. TAK is a government-developed geospatial platform used across U.S. military, federal, state, and local government organizations, as well as by U.S. partner nations. According to the U.S. Army TAK Product Center, the TAK ecosystem supports 15 Departm
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom