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
LTM Launches AI 1000 to Develop the Next Generation of Forward Deployed Engineers12.6.2026 09:14:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today announced AI 1000, a strategic workforce transformation initiative anchored by a dedicated Center of Excellence (CoE). The program will develop a pool of 1,000+ AI-certified engineers, including Forward Deployed Engineers (FDEs), to help enterprises adopt, deploy, and scale AI. The launch comes amid a major shift in enterprise tech talent. The FDE — among the fastest-growing roles in the AI ecosystem — combines the technical knowledge of LLMs and domain SLMs with business understanding to turn ideas into quantifiable ROI accretive outcomes and to drive client adoption. AI 1000 is LTM’s structured response to this shift: it provides the training, platforms, and governed career frameworks to develop FDEs at scale. AI 1000 takes an end-to-end approach to talent development via a four-stage model: Identify, Enable, Deploy, and Govern. It starts by identifying high-potential engineers using a proprietary AI Readi
NTT DATA Group Appoints Kazuhiko Nakayama as New President and Chief Executive Officer12.6.2026 09:00:00 EEST | Press release
NTT DATA Group, a global leader in AI, digital business and technology services, today announces that the Board of Directors has approved the appointment of Kazuhiko Nakayama as NTT DATA Group’s new President and Chief Executive Officer, effective June 12, 2026. Yutaka Sasaki, former President and CEO of NTT DATA Group, will assume the role of Senior Executive Vice President of NTT, Inc., effective June 18. Serving most recently as CFO of NTT DATA Group, Nakayama brings proven leadership and a depth of expertise and experience in defining business strategy and delivering growth. He will continue to strengthen the competitive advantages of the $30+ billion business whilst accelerating it’s AI-centered growth strategy across the 70+ countries and regions in which it operates. NTT DATA Group’s growth strategy will focus on two key areas alongside its core business operations: AI‑empowered New Value & Productivity; and Next‑Generation Infrastructure. It aims to lead in areas such as Operat
Venture Global Announces Closing of $2.25 Billion of Senior Secured Notes12.6.2026 00:00:00 EEST | Press release
Venture Global LNG, Inc. (“Venture Global”) announced today that its wholly-owned subsidiary, Venture Global LNG, Inc. (the “Issuer”) has closed its offering of $1.125 billion aggregate principal amount of its 6.375% senior secured notes due 2034 (the “2034 Notes”) and $1.125 billion aggregate principal amount of its 6.625% senior secured notes due 2036 (the “2036 Notes” and, together with the 2034 Notes, the “Notes”). The Issuer used the gross proceeds from the offering to redeem all of the Issuer’s outstanding 8.125% senior secured notes due 2028 (the “Existing 2028 Notes”) and used cash on hand to pay the redemption premium and related fees and expenses for the offering and the redemption. The 2034 Notes will mature on December 15, 2034, and the 2036 Notes will mature on June 15, 2036. The Notes were issued at par. The Notes will initially not be guaranteed by any of the Issuer’s subsidiaries. In the future, certain of the Issuer’s subsidiaries that incur or guarantee certain amount
Venture Global and Atlantic-SEE Announce Expansion of Long-Term LNG Sales and Purchase Agreement with Greece11.6.2026 23:30:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and ATLANTIC – SEE LNG TRADE S.A. of Greece announced an expansion of their existing Sales and Purchase Agreement (SPA) for the purchase of U.S. liquefied natural gas (LNG) from Venture Global for twenty years starting in 2030. Under the deal, Atlantic-SEE is doubling their existing contract with Venture Global from a minimum of 0.5 million tonnes per annum (MTPA) to 1.0 million tonnes per annum (MTPA). Atlantic-SEE LNG is a newly formed joint venture announced in November at the 6th Partnership for Transatlantic Energy Cooperation (PTEC) conference hosted in Athens, Greece between Greek companies AKTOR Group and DEPA Commercial. The announcement of this expanded supply agreement follows Venture Global’s previously announced investment in regasification capacity at the Alexandroupolis LNG import terminal in Greece, which currently accounts for approximately 25% of the terminal’s total capacity. The Alexandroupolis LNG FSRU receiving terminal and S
Merrithew ® Expands Global Mindful Movement Leadership with Acquisition of the GYROTONIC ® Organization11.6.2026 18:30:00 EEST | Press release
Merrithew®, a global leader in mindful movement education and equipment and creator of internationally recognized programs including STOTT PILATES®, ZEN•GA®, Halo® Training and Total Barre®, today announced the acquisition of the GYROTONIC® organization, creator of the globally respected GYROTONIC® and GYROKINESIS® methods. Founded by Juliu Horvath, the GYROTONIC® and GYROKINESIS® methods are internationally recognized for their distinctive approach to movement, combining fluidity, strength, mobility, coordination, and rehabilitation through specialized equipment and movement sequences. Practiced in studios and wellness centers worldwide, the methods have cultivated a deeply loyal global community of instructors, trainers, therapists, and movement professionals. The acquisition marks a significant milestone in Merrithew International Inc.’s growth strategy and reflects Merrithew’s commitment to growing the rapidly expanding global mindful movement category. The addition of the GYROTONI
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