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
SLB, Liberty Energy to Form Strategic Alliance for Data Center Infrastructure and Power14.7.2026 14:50:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) today announced an agreement with Liberty Energy Inc. (NYSE: LBRT) to form a strategic alliance that will deliver modular infrastructure and integrated power generation solutions for new data center projects globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714708557/en/ A rendering of modular data center infrastructure with co-located, behind-the-meter generation. The collaboration will bring together complementary expertise in modular infrastructure, power generation and operations to support the rapid deployment of new data center capacity and help the world’s leading AI companies address increasingly complex energy requirements. The growth of AI and high-performance computing is driving unprecedented demand for data center capacity. As developers work to add new compute capacity, many are seeking behind-the-meter power solutions that can be deployed independently
ACE Welcomes Telekom Srbija Group as Newest Member, Expanding Anti-Piracy Fight in Southeast Europe14.7.2026 14:21:00 EEST | Press release
The Alliance for Creativity and Entertainment (ACE), the world’s leading anti-piracy coalition, today announced Telekom Srbija Group as its newest member, strengthening ACE’s content protection efforts in Southeast Europe and across the global digital media ecosystem. Telekom Srbija Group is a leading telecommunications and media group in Southeast Europe, providing connectivity, multimedia and digital services across the region. Operating across 15 markets regionally and globally, and serving more than 14 million users, the Group has established a strong and expanding international footprint. In recent years, the company has expanded beyond its core telecommunications business to become a major investor in premium television, film, sports and digital content, developing its own production and distribution capabilities and licensing its content to international platforms and broadcasters. “Telekom Srbija Group’s decision to join ACE strengthens our collective ability to address digital
STARTEEPO Increases Xerox Position to 8.8 Million Shares, Becomes Second-Largest Common Shareholder14.7.2026 14:00:00 EEST | Press release
STARTEEPO Invest (“STARTEEPO”), a Prague-based alternative investment fund focused on high-conviction public equity investments, today announced that it has increased its beneficial ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”) to 8.8 million common shares, together with options on an additional 140,000 shares, as disclosed in an amended Schedule 13D filing with the U.S. Securities and Exchange Commission. Based on publicly available ownership disclosures, STARTEEPO is now Xerox’s second-largest holder of common stock. “We have reached the target ownership level established for the current phase of our investment strategy,” said Frantisek Bostl, Chairman of the Board of STARTEEPO Invest. STARTEEPO’s investment thesis remains centered on balance sheet improvement, disciplined capital allocation, operational execution, the successful integration of Lexmark, and what we believe is the market’s continued undervaluation of Xerox’s long-term strategic positionin
European Commission Approves Erbitux ® (cetuximab) in Combination with Encorafenib and FOLFOX for First-Line Treatment of Metastatic Colorectal Cancer with BRAF V600E Mutation14.7.2026 12:00:00 EEST | Press release
Merck, a leading global science and technology company, today announced that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. Erbitux is now indicated in combination with encorafenib for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) — both in first-line treatment in combination with FOLFOX (BREAKWATER regimen) and for patients who have received prior systemic therapy (BEACON regimen). The first-line approval is based on results from the Phase 3 BREAKWATER trial, which showed that the cetuximab–encorafenib–FOLFOX combination delivered statistically significant and clinically meaningful improvements in the dual primary endpoints of objective response rate (ORR) and PFS, as well as a significant overall survival benefit — reducing the risk of death by 51% versus chemotherapy with or without bevacizumab. ”The approval of Erbitux in combination with encorafenib and FOLFOX marks an important milestone for patients wit
Nordic Firms Seek Green, Sovereign AI Infrastructure14.7.2026 12:00:00 EEST | Press release
Nordic enterprises are adopting private and hybrid cloud infrastructure that combines AI-ready capacity, local residency and low-carbon operations as high-performance workloads and geopolitical risk reshape IT strategies, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm. The 2026 ISG Provider Lens® Private/Hybrid Cloud — Data Center Services report for the Nordics finds that the region is evolving from a hosting destination into a backbone for European data processing. Enterprises are using the Nordics’ renewable energy and natural cooling to support cloud strategies that balance large scale with environmental consciousness and compliance with data sovereignty regulations. “Nordic enterprises are connecting infrastructure decisions to resilience, data control and sustainability rather than treating cloud as a capacity purchase,” said Susanta Dey, director, ISG EMEA Cloud and
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