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
Accertify's Q2 Global Air Travel Fraud Report Finds Fraud Pressure Intensifying Across Middle East and Africa15.7.2026 14:00:00 EEST | Press release
Accertify, a leading fraud decisioning provider whose Predictive Yes Platform helps merchants say yes to more good customers, more revenue, and more growth, today announced the release of its Global Air Travel Fraud Report: Q2 2026, a quarterly analysis examining how fraud pressure varies across global airline markets based on departure city at time of booking. Based on analysis of 132.9 million airline booking transactions processed between April and June 2026, the report evaluates prevented fraud rates across 537 departure cities that each processed at least 10,000 transactions during the quarter, providing airlines with a data-driven view of where Accertify's Predictive Yes platform intervened most frequently at booking. The Q2 findings reveal that fraud pressure continues to vary significantly by market, with the most notable shift occurring across the Middle East and Africa. The region's average prevented fraud rate more than doubled quarter over quarter, from 0.95% to 2.03% — the
Forrester’s 2027 Budget Planning Guides: After A Year Of Caution, Business And Tech Leaders Are Ready To Invest Again15.7.2026 12:00:00 EEST | Press release
According to Forrester’s (Nasdaq: FORR) 2027 Budget Planning Guides, business and technology leaders are approaching 2027 with renewed confidence as they increasingly accept volatility as a permanent feature of the business environment. After a year of more cautious spending, more than 80% of leaders expect their budgets to increase over the next 12 months, with as many as one-quarter anticipating growth of 10% or more. But planning in the age of AI demands more than bigger budgets: Increasing investment without modernizing operating models, strengthening data foundations, and improving AI readiness will only accelerate fragmented data, duplicated work, and technical debt. To realize AI’s full potential, leaders must rethink their strategies and prioritize investments in operational foundations, governance, and experimentation that drive tangible outcomes. This year, optimism is widespread across functions: 82% of technology decision-makers and 91% of marketers expect budget increases
Post-Quantum’s Algorithm - Classic McEliece - Achieves Global ISO Standardization to Protect the World From Quantum Cyber Attack15.7.2026 11:00:00 EEST | Press release
It’s proven that today’s encryption is vulnerable to attack by a sufficiently mature quantum computer running Shor’s algorithm - a catastrophic event commonly known as Q-Day. Even before such a cryptographically relevant quantum computer emerges it is known that adversaries are stealing encrypted data now, which can be decrypted later - also known as Harvest Now, Decrypt Later (HNDL). Google’s recent use of Artificial Intelligence (AI) to optimise Shor’s algorithm reduces the number of physical qubits required to break today’s encryption, therefore shortening the timeline to Q-Day. This has led prominent experts to estimate today’s encryption may be broken as-soon-as the next three years. It’s against this backdrop that the International Organisation for Standardisation (ISO) has included the Classic McEliece algorithm as part of its standard for Asymmetric Ciphers (ISO/IEC 18033-2). Organisations from ISO’s 177 member states can now upgrade to Classic McEliece using an international s
Thredd Joins The Visa Agentic Ready Programme, Bringing Agent Network Readiness To Issuers Across Europe, Starting With Zilch15.7.2026 10:00:00 EEST | Press release
Thredd, the AI-first issuer processing platform, today announced it has joined the Visa Agentic Ready programme, enabling issuers across Europe to participate in agent-initiated payments without rebuilding their payments infrastructure. Consumer payments platform Zilch will be among the first issuers on the platform to enable agent-initiated payments for its cardholders. As a processor and enabler, Thredd sits at the trust layer of the payments ecosystem. By joining the programme, Thredd is ready to support Visa and its clients as the market moves into agentic commerce. Agentic commerce introduces a new type of payment initiator: An AI agent acting on a cardholder's behalf. The core payments principles do not change. Cardholder permission, issuer approval, authentication and fraud monitoring all still apply. What changes is how trust is established and enforced at the point an agent transacts. Taking a Zilch customer as an example, a cardholder might ask an AI agent to find a product w
Surgerii Robotics Announces First European Installation of the SHURUI ® Single-Port Surgical System at Vall d'Hebron University Hospital15.7.2026 10:00:00 EEST | Press release
Surgerii Robotics today announced the first European installation of its SHURUI Single-Port (SP) Surgical System at Vall d'Hebron University Hospital in Barcelona, Spain, one of Europe's leading academic medical centers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713209503/en/ The first pediatric procedure performed with the SHURUI SP system was a nephroureterectomy on a twelve-year-old boy whose kidney and ureter had become infected and non-functional due to multiple stones. The SHURUI SP system is CE-marked for adult and pediatric use, making it the only CE-marked single-port robotic surgical system currently indicated for pediatric procedures in Europe. The installation marks an important milestone in the international expansion of Surgerii Robotics and the introduction of the technology into a major European reference center. As part of this collaboration, Vall d'Hebron University Hospital has become the first hos
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