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
Armis Named a Leader for Second Consecutive Year in 2026 Gartner® Magic Quadrant™ for CPS Protection Platforms4.3.2026 17:12:00 EET | Press release
Armis, the cyber exposure management & security company, today announced that it has been named a Leader in the 2026 Gartner Magic Quadrant for CPS Protection Platforms for the second consecutive year. “In an era of agentic AI, the security of our cyber-physical systems has become a strategic imperative for enterprises and governments globally; it is a pivotal pillar of global stability,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “We believe this back-to-back recognition from Gartner reflects our continued commitment to helping organizations secure the complex, critical world of CPS and reinforces the strength of our unified, proactive platform approach. Our innovation pipeline, which is aligned with our customers' needs, will continue to prioritize protecting critical environments to keep society safe and secure.” Armis was named a Leader in this report among the 13 vendors that were evaluated. Armis Centrix™, the Armis Cyber Exposure Management Platform, was evaluated within
Svante Acquires Carbon Dioxide Removal Project Developer, Carbon Alpha Corp.4.3.2026 17:00:00 EET | Press release
Svante Technologies Inc. (Svante), a leader in carbon management, and Calgary-based Carbon Alpha Corporation (Carbon Alpha) today announced that Svante has acquired Carbon Alpha and its related subsidiaries, including Carbon Alpha Development Corp. and its ownership interests in North Star Carbon Solutions Corp. and North Star Carbon Solutions Limited Partnership, a project developer for carbon capture and storage (CCS) in Western Canada. With this transaction, Carbon Alpha’s flagship North Star Bioenergy Carbon Capture and Storage (BECCS) project, developed in partnership with the Meadow Lake Tribal Council (MLTC) in Saskatchewan, joins Svante’s business unit portfolio alongside Svante Development Inc. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304605629/en/ This transaction strengthens Svante’s expertise in geological CO2 storage as part of a fully integrated carbon management company ready to build, own, and operat
Binarly Announces Leadership Transition as Enterprise Demand Accelerates for Supply-Chain Security4.3.2026 17:00:00 EET | Press release
Binarly, the industry leader in software and firmware supply‑chain security, today announced a leadership transition as the company enters its next phase of growth. Founder and current CEO Alex Matrosov has joined the company’s Board, and Gwenyth Castro has joined as Chief Executive Officer to scale global go-to-market and enterprise growth. Binarly developed its Transparency Platform on a unique, patented technology core designed to help the world’s largest enterprises identify and reduce third-party software risk across complex environments. The platform is trusted by organizations including Meta and Dell, among others. “We built Binarly to solve a problem the industry kept ignoring: you can’t secure what you can’t see,” said Alex Matrosov, Founder of Binarly. “Over the last five years, this team turned deep program analysis and vulnerability research into a platform trusted by some of the world’s most demanding enterprises. Now, as AI accelerates how software is built and shipped, t
Andersen Consulting Strengthens Cybersecurity Capabilities Through Collaboration with A3Sec4.3.2026 16:30:00 EET | Press release
Andersen Consulting enhances its cybersecurity and technology transformation offerings through a Collaboration Agreement with A3Sec, a firm specializing in data-driven threat detection, incident response, and exposure management. Headquartered in Spain with offices in Mexico and Colombia, A3Sec has more than 14 years of experience helping public and private organizations across the financial services, telecommunications, energy, government, and enterprise sectors secure their digital assets. Operating its Security and Digital Surveillance Center® (CSVD®) 24/7 with a team of more than 180 cybersecurity professionals and serving more than 280 clients worldwide, the firm delivers integrated cybersecurity services, including managed detection and response, cyber telemetry, threat intelligence, and crisis management, helping clients strengthen resilience and transform risk into strategic advantage while effectively managing exposure and minimizing risk. “Our purpose has always been to prote
Unleash Raises $35M Led by One Peak to Help Enterprises Ship AI-driven Software Faster, Safer, and Smarter4.3.2026 16:00:00 EET | Press release
Unleash, the open-source FeatureOps company, today announced a $35 million Series B financing led by One Peak, with participation from existing investors Spark Capital, Frontline Ventures, and Firstminute Capital. The new funding will be used to accelerate product innovation and global expansion as enterprises confront the opportunities and risks of AI-accelerated software delivery. AI has dramatically accelerated software development, creating a generational opportunity for anyone in an enterprise to turn ideas, prompts, and prototypes into applications. But AI has also outpaced the systems designed to control software delivery. DORA research shows that a 25% rise in AI adoption correlates with a 7% drop in software stability. Enterprises are shipping code 2-3x faster with AI, yet outages caused by uncontrolled feature rollouts and missing kill switches are costing businesses millions in lost revenue, prolonged customer downtime, and brand damage. FeatureOps is emerging as the missing
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