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
Coherent Solutions Launches AKTIV, a Dedicated Fitness and Wellness Technology Business Unit10.11.2026 17:34:00 EET | Press release
Coherent Solutions officially launches AKTIV, a dedicated business unit focused exclusively on fitness and wellness technology. AKTIV brings together over 15 years of fitness industry experience, dedicated leadership, and global engineering capabilities to help fitness and wellness operators and equipment manufacturers compete through technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110242555/en/ Coherent Solutions officially launches AKTIV “We know the fitness and wellness industry and the challenges operators and manufacturers face. With AKTIV, we spend less time defining what needs to be built and more time delivering solutions that improve operations, member experiences, and business performance,” said Vadim Bartlov, Managing Director of AKTIV. AKTIV builds on Coherent Solutions' established work with leading fitness companies, including Life Time, Planet Fitness, Anytime Fitness, Orangetheory, and BowFlex,
Mouser Explores the Newest Computing Technologies Beyond Moore's Law in its Technology Series10.11.2026 17:12:00 EET | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, Moving Beyond Moore's Law. The series explores how engineers are advancing computing performance as traditional semiconductor scaling approaches its physical limits, from chiplets and advanced packaging to silicon photonics and emerging transistor technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006980414/en/ Explore what comes after Moore's Law as the industry seeks new paths to computing performance. As a key driver of semiconductor advancement, Moore's Law has served as a roadmap for the industry, describing the trend of transistor counts on integrated circuits doubling approximately every two years. With conventional silicon transistors becoming increasingly difficult to shr
Netceed appoints Eric Updyke as Group CEO10.11.2026 16:15:00 EET | Press release
Netceed, a global leader in delivering supply chain solutions across broadband, data center and energy infrastructure, today announced the appointment of Eric Updyke as Group CEO, effective 10th November, 2026. He succeeds Alper Türken, who will step down as CEO on 10th November, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110492065/en/ Netceed appoints Eric Updyke as Group CEO Eric brings more than 35 years of leadership experience in communications and technology infrastructure. Most recently, he served as CEO of Spirent Communications plc from 2019 to 2025. At Spirent, he led the company's shift from a hardware-centric vendor to a solutions provider built on software, automation and services. He also expanded the business into new sectors, including AI data center providers, and guided it through a strategic sale, culminating in its $1.5 billion acquisition by Keysight Technologies in 2025. Before Spirent, Eri
80% of IT Leaders Say the Digital Workplace Is Critical to AI Success, Yet Only 10% Have Fundamentally Redesigned It, Lenovo Research Finds10.11.2026 16:00:00 EET | Press release
Eight in ten IT decision makers say the digital workplace is critical to successful AI-led transformation, yet only 10% report fundamentally redesigning it for AI, according to Lenovo’s sixth Work Reborn report, The AI-ready workplace. The findings expose a significant gap between deploying AI tools and the operating capabilities needed to integrate them into how work gets done across an organization. The report frames workplace readiness as a connected system spanning people, workflows, technology, support and governance, with each contributing to how enterprises translate AI ambition into business outcomes at scale. Based on an August 2026 survey of 1,200 IT leaders at organizations with at least 1,000 employees across 12 countries, the report examines the workplace conditions needed to translate AI deployment into measurable value. While 76% rank AI-led transformation among their organization’s top IT priorities, only 27% have scaled AI across business functions. AI Deployment Is No
Nearly Nine in 10 Private Capital GPs Face Data Validation Challenges10.11.2026 16:00:00 EET | Press release
Nearly nine in 10 (88%) of private capital general partners (GPs) surveyed say their finance and operations teams spend between 11% and 50% of their time validating, reconciling, recalculating or recreating administrator outputs, according to new research from CSC, the leading provider of global business administration and compliance solutions¹. CSC surveyed more than 300 GPs and 200 limited partners (LPs) across North America, Europe, the U.K., and Asia Pacific. The report, Future Private Capital CFO 2026, examines how fund finance, liquidity management, reporting, outsourcing, cybersecurity, and AI governance are reshaping the role of the private capital CFO. Half of GPs say their finance and operations teams spend 11% to 25% of their time validating, reconciling, recalculating, or recreating administrator outputs, while 38% put the figure at 26% to 50%. As firms add asset classes, structures, jurisdictions, liquidity tools, and reporting requirements, complexity is increasingly bein
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