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
Rave Sues Apple in Five Countries Over App Store Removal7.5.2026 18:03:00 EEST | Press release
Rave Inc. (“Rave” or the “Company”), the developer and operator of the Rave app, a cross-platform co-viewing “super app” with more than 225 million downloads, today announced that it has filed antitrust lawsuits against Apple in five countries: the United States, Canada, Brazil, the Netherlands and Russia. The lawsuits challenge Apple’s unilateral and anticompetitive decision to remove Rave from its App Store, thereby distorting competition, reducing consumer choice in co-viewing functionalities and increasing the costs to users of switching between iPhone and competing smartphone devices. Rave operates a social entertainment app that allows users in different locations to watch their favorite videos, movies, and TV shows together in real time across multiple operating systems and devices, including iOS, Android, Windows and macOS, and communicate through chat and voice. Rave alleges that this cross-platform experience threatened Apple’s closed iOS ecosystem, which Apple maintains by l
emnify named a Visionary in the 2026 Gartner ® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide7.5.2026 18:00:00 EEST | Press release
emnify, a global provider of cloud-native IoT connectivity solutions, today announced it has been recognized as a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507642325/en/ emnify named a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide. Get the report As a first-time recognized vendor, emnify believes this recognition reflects its forward-looking approach to IoT connectivity, building a platform designed to anticipate where enterprise needs are heading rather than replicating the connectivity models of the past. "We feel being named a Visionary in our first appearance in the Gartner® Magic Quadrant™ recognizes our deliberate strategy of the last decade: from owning our core network and pioneering satellite-cellular convergence on a single SIM, to embedding fine-tuned AI models
UAE Commits $49bn to Local Manufacturers7.5.2026 17:00:00 EEST | Press release
The United Arab Emirates (UAE) pledged $49 billion in industrial procurement opportunities on Monday and announced plans to localize more than 5,000 products as the Gulf state doubled down on its industrial sovereignty agenda. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507855698/en/ UAE commits $49bn to local manufacturers (Photo: AETOSWire) Dr. Sultan Al Jaber, UAE Minister of Industry and Advanced Technology, made the announcement at the opening of the fifth edition of Make it in the Emirates, which follows a period that has tested the region. “History remembers the challenges nations face. But it also remembers how nations respond to them and what they build next,” he said. TA’ZIZ announced $40.5 billion worth of agreements aimed at expanding UAE chemical production capacity. The opportunities include offtakes and $2 billion of financing for the UAE’s first world-scale methanol plant. A $270 million National Indust
Andersen Consulting Strengthens Organizational Transformation Capabilities with Afiniti7.5.2026 16:30:00 EEST | Press release
Andersen Consulting announces a Collaboration Agreement with Afiniti, a global business transformation consultancy headquartered in the United Kingdom that helps organizations deliver and sustain complex change programs. Founded in 2003, Afiniti is a global business change consultancy based in the UK and U.S., supporting clients through complex transformation across people, process, systems, and data, and bringing change to life through creative consulting services. The firm primarily serves highly regulated, safety-driven, and asset-intensive organizations with large, geographically dispersed workforces across sectors including energy, utilities, life sciences, transport, and construction. Afiniti works with well-known brands to deliver end-to-end expertise across organizational, digital and AI, cultural, and operating model transformation, particularly in complex scenarios such as mergers and acquisitions, large-scale technology adoption, and underperforming change programs that have
Datavault AI Announces Board of Directors Has Requested Management’s Complete Plan for Dividend Spin-Out of Acoustic Sciences Division into Stand-Alone Public Company7.5.2026 16:07:00 EEST | Press release
Datavault AI Inc. (“Datavault AI” or the “Company”) (NASDAQ:DVLT), a pioneering technology licensing company seeking to redefine data valuation, monetization, and secure Web 3.0 experiences, today announced that Company management has commenced its evaluation of a potential dividend spin-out of the Company’s Acoustic Sciences division which includes its ADIO®, WiSA®, Event Citadel™, and API Media operations into a new stand-alone public company, which is proposed to be named “API Media”. The Company has reserved the ticker symbol “ADIO” for the proposed spin-out entity and currently intends that API Media will be listed on NASDAQ following completion of the proposed transactions, which remain subject to approval by the Company’s board of directors, definitive agreement, and satisfaction of closing conditions, as well as any regulatory approvals that may be required in connection therewith. The Company has engaged Houlihan Lokey as its financial advisor and Paul Hastings LLP as its lega
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