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
NetApp Helps Customers Accelerate Adoption of Latest VMware Cloud Foundation Innovations2.9.2026 23:30:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, announced new capabilities in NetApp ONTAP® have been tested and validated to support VMware Cloud Foundation (VCF) 9.1, giving customers an optimized and secure data infrastructure foundation for their private and hybrid clouds. By combining the advanced capabilities of VCF 9.1 with cost-effective and enterprise data management with built-in security features from NetApp, including safeguarding data against ransomware attacks with rapid recovery, mutual customers can lower costs and accelerate the deployment of their AI software into production. VMware Cloud Foundation 9.1 provides enterprises with a unified private cloud platform for running both traditional and modern workloads. NetApp's solutions are tested and validated to support VCF 9.1 environments, enabling mutual customers to immediately begin taking advantage of VCF 9.1 innovations when they upgrade, with a data infrastructure layer already proven to work w
Venture Global Announces Closing of $3,000,000,000 364-Day Senior Secured Revolving Credit Facility2.9.2026 23:30:00 EEST | Press release
Venture Global, Inc. (“Venture Global”) announced today that its subsidiary Venture Global LNG, Inc. (“VGLNG”) has entered into a new, $3,000,000,000 364-day revolving credit facility (the “Facility”). Venture Global expects to use the proceeds from borrowings under the Facility for general corporate purposes of VGLNG and its subsidiaries, including to fund certain project costs for the CP2 and Plaquemines bolt-on expansions prior to their respective FIDs. Bank of America, N.A. served as Coordinating Lead Arranger and Sole Bookrunner and will also serve as Administrative Agent. BBVA, Goldman Sachs, ING, J.P. Morgan, Mizuho, MUFG, NBC, RBC, Scotia, SMBC, U.S. Bank, and Wells Fargo served as Coordinating Lead Arrangers and Barclays, Santander, and Deutsche Bank served as Joint Lead Arrangers. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Vent
Invivoscribe Begins Commercial Shipments of PrepQuant ™ Systems, Enabling High-Sensitivity Sample Preparation for MRD Testing2.9.2026 22:31:00 EEST | Press release
Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced that commercial shipments of the PrepQuant™ System have begun in North America. First unveiled at the American Association for Cancer Research Annual Meeting in April 2026, PrepQuant is now being delivered to customers, marking the platform's progression from development and validation into commercial deployment. The commercial milestone extends Invivoscribe's capabilities into laboratory instrumentation and addresses a critical bottleneck in highly sensitive molecular testing: efficiently recovering, concentrating, and quantifying DNA from larger blood and plasma inputs. PrepQuant is assay agnostic, designed to produce concentrated genomic DNA and cell-free DNA (cfDNA) suitable for a full range of downstream molecular workflows, including MRD assays intended to detect very low levels of residual disease. MRD Sensitivity Starts Before the Assay As MRD testing moves tow
C.H. Guenther Opens Centre of Excellence in Coventry, UK to Accelerate Bakery Innovation and Support Future Manufacturing Growth Across UK and Europe2.9.2026 19:00:00 EEST | Press release
C.H. Guenther & Son LLC (“C.H. Guenther” or “CHG”), a leading food manufacturer, has opened a new Centre of Excellence (the “Centre”) at its flagship Coventry bakery, creating a dedicated innovation and customer collaboration hub designed to accelerate the development of premium bakery products across the UK and Europe. The new facility has been designed to support CHG’s customers including leading global quick service restaurants, foodservice operators and retailers as they develop, test and refine new bakery products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902696890/en/ The purpose-built, 172-square-metre Centre of Excellence brings together a commercial-scale bakery, customer demonstration kitchen, sensory evaluation facilities, innovation suite and dedicated collaboration spaces in one specialized location. Designed to support and accelerate product development from concept through to commercial manufacturing,
Record Asset Management Enters New Phase of Growth2.9.2026 18:35:00 EEST | Press release
Record Asset Management GmbH (“RAM”), a subsidiary of London-listed Record plc (“Record” or the “Group”), is pleased to announce that it is now operating cashflow positive, thereby marking a transition from its investment phase into a growth business within the Group, and a significant milestone towards sustainable profitability. RAM is the European asset management arm of Record, the London-listed specialist investment group managing USD 122 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. RAM was established as a sister company to Record’s core currency business and obtained its BaFin license in 2022. RAM has grown rapidly in the last two years and has developed into a diversified private markets platform with dedicated infrastructure e
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