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
Klarna Card reaches 5 million active customers19.3.2026 16:31:00 EET | Press release
Klarna, the global digital bank and payments provider, today announced that the Klarna Card has reached 5 million active customers globally, underscoring rapid adoption as consumers shift towards new forms of payment which provide more control over day-to-day money management. The card draws from the customer's own funds for everyday spending, with the option to spread the cost of a specific purchase, like a large appliance or a flight, when it makes sense to do so. The result is a card that offers genuine spending control without the long-term debt obligations that come with traditional credit cards. The card’s growth is reinforced by Klarna’s membership program. The program offers premium perks such as airport lounge access, travel insurance, and lifestyle subscriptions — without requiring users to take on debt, meet spending thresholds, or revolve balances. By separating everyday spending from rewards, Klarna is challenging the strings-attached model legacy banks have long relied on
Andersen Consulting Expands Technology Platform in France19.3.2026 15:30:00 EET | Press release
Andersen Consulting expands its digital transformation offering through a Collaboration Agreement with Teolia Consulting, a French firm specializing in project and product management, cloud platform engineering, data transformation, and Atlassian suite integration and adoption. Founded in 2014, Teolia Consulting helps organizations achieve digital performance, from agile methodology to time-to-market solutions. The firm’s expertise is focused on delivering integrated strategies that align technology with organizational change. The firm works across industries including banking, insurance, fashion, and retail, empowering clients to strengthen resilience and accelerate digital maturity. “At Teolia Consulting, we believe that true transformation happens when technology and people evolve together,” said Lucienne Jacquet, managing partner of Teolia. “By collaborating with Andersen Consulting, we not only amplify our impact but also gain access to a worldwide organization of like-minded indi
Stonebranch Releases 2026 Global State of IT Automation Report, Revealing Orchestration as the Missing Link for AI Adoption and Trust19.3.2026 15:30:00 EET | Press release
Stonebranch, a leading provider of service orchestration and automation solutions, today released its annual 2026 Global State of IT Automation Report, the company’s most comprehensive research study to date. Based on responses from 402 IT automation professionals spanning C-suite executives to individual contributors across North America, EMEA, Latin America, and APAC, the report provides a detailed, data-driven portrait of how enterprises are investing in, deploying, and deriving value from IT automation in 2026. “This year’s findings highlight an important shift in how organizations approach automation,” said Giuseppe Damiani, CEO of Stonebranch. “Organizations are now building automation as strategic infrastructure — a governed, scalable foundation that spans hybrid environments, operationalizes AI, and delivers automation-as-a-service to thousands of users across the enterprise. The companies that get orchestration right are not just running more efficient IT operations. They are
Perma-Pipe Accelerates Growth with New U.S. Northeast Facility Investment to serve Artificial Intelligence Data Center customers, Provides Middle East Operations’ Update and Concludes the Board’s Review of Strategic Alternatives19.3.2026 15:00:00 EET | Press release
Perma-Pipe International Holdings, Inc. (the “Company”) today announced a strategic expansion initiative focused on accelerating growth through entry into the high-demand U.S. Northeast region. The Company is positioning itself to capitalize on the rapidly expanding Artificial Intelligence (“AI”)-driven data center market in both the United States and international markets while continuing to reinforce its leadership in critical infrastructure solutions. As part of this growth strategy, Perma-Pipe will prioritize investments aimed at expanding its presence in the rapidly evolving AI data center sector. The initiative reflects the Company’s long-term commitment to supporting next-generation technology infrastructure and strengthening its position in the global energy, industrial, and infrastructure markets. Expansion in the U.S. Northeast President & Chief Executive Officer, Saleh Sagr said, “We are excited to announce the expansion of our operations with a new facility in the Northeast
Armis Launches First-of-Its-Kind Benchmark Report Warning of Critical Security Gaps in AI-Native Development19.3.2026 14:00:00 EET | Press release
Armis, the cyber exposure management & security company, is warning that the rapid enterprise adoption of AI-native development is outpacing critical security safeguards, leaving organizations exposed to systemic vulnerabilities. New research from Armis Labs’ Trusted Vibing Benchmark Report, which evaluates 18 leading generative AI models across 31 test scenarios, reveals a 100% failure rate in generating secure code. These vulnerabilities are most prevalent in high-risk areas like memory buffer overflows, design file uploads and authentication systems. Therefore, organizations should immediately implement AI-native application security controls to reduce risk. “The era of vibe coding is here, but speed should not come at the cost of security,” said Nadir Izrael, CTO and Co-Founder of Armis. “Our research finds that the worst offenders are the same ones selling security solutions for the very vulnerabilities their models create. If the industry continues to integrate autonomous code wi
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