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
Phenom Adds Major Headline Speakers as IAMPHENOM Europe Approaches Sold-Out Status6.10.2026 16:30:00 EEST | Press release
Phenom, the leader in applied AI built to redesign work operations for hiring faster, developing better and retaining longer, today announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006714151/en/ Phenom announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. The two-day conference gives attendees what other HR events can’t: an inside look at AI agents already in production, automated workflows tailored to specific business contexts and the dramatic results they are already delivering. Across keynotes, customer sessions, hands-on experiences and peer networking with the continent’s top CHROs and HRIT decision-makers, guests can participate in discussion
European Firms Struggle to Keep Pace with Growing DSAR Demands, New Reveal Study Finds6.10.2026 16:00:00 EEST | Press release
New research published today byReveal, the provider of integrated AI-native platforms spanning the dispute resolution lifecycle, found that large European organisations complete fewer than half of data subject access requests (DSARs) within the one-month deadline required under the General Data Protection Regulation (GDPR), a shortfall the study ties directly to a near-universal absence of purpose-built technology. Nearly nine in 10 organisations still run DSARs on manual or general-purpose workflows, with no dedicated tooling in place. The report, based on a survey of 213 legal and privacy professionals at large European enterprises, is the first of its kind to benchmark how organisations across the region are managing DSAR compliance at scale. The findings expose structural inconsistencies between how organisations perceive their DSAR processes and how those processes perform. Ninety percent of respondents said they are confident their process would withstand scrutiny from an Informa
Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets6.10.2026 16:00:00 EEST | Press release
Rochester Electronics today announced the launch of fully enabled e-commerce capabilities across its regional websites, allowing customers in key global markets to search for, source, and purchase authorized semiconductors in their local language. While Rochester's regional sites previously offered localized content and product information, they now support a complete end-to-end purchasing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006914131/en/ Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets The newly upgraded platforms are now live in Portuguese (Brazil), Spanish (Mexico), French, German, Italian, and Polish, complementing Rochester’s existing full e-commerce platforms in English, Chinese, Japanese, and Korean (South Korea). Customers can now complete transactions directly through their local sites, simplifying sourcing, improving efficiency, and reducing process
Xsolla Shows Brand Owners How to Create Value for Video Players at Brand Licensing Europe With Rewarded Marketing6.10.2026 16:00:00 EEST | Press release
Xsolla, a global commerce company, today announced it will be at Brand Licensing Europe 2026 at ExCeL London, October 6 to 8, to show brand owners how to engage with video game players by creating quest-based programs and value new users actually value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006443167/en/ Graphic: Xsolla Video games are one of the largest categories of entertainment spending in the world, yet most brands still treat the category as an experiment: a one-off promotional stunt or a single media buy, not a lasting engagement program. The traditional formats brands default to were never built for players. Interstitial pop-ups disrupt gameplay, banner ads go unnoticed, and in-game activations remain cumbersome and expensive to execute. The idea is already proven in games, where players have purchased, collected, and valued digital items for years. The relationship between players and games is built on t
New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support6.10.2026 16:00:00 EEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced findings from the 2026 IT Virtualization Survey – What’s Next for VMware Users, a new global survey of nearly 300 VMware user organizations conducted by Unisphere Research on behalf of Rimini Street. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006014490/en/ New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support Cost Cited as the Number One Factor in Seeking Alternative VMware Solutions Key Findings: 90% of respondents said they are considering alternatives to VMware due to higher licensing costs, while 54% cited the end of perpetual license support as another reason to evaluate other options. The research shows that cost remains the leading driver of virtuali
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