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
Galderma Announces U.S. FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission2.2.2026 08:00:00 EET | Press release
Galderma (SIX: GALD) today announced that the U.S. FDA has accepted the BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. Galderma has worked closely with the U.S. FDA to implement adjustments to its manufacturing process. Galderma is committed to using its expertise and heritage in the neuromodulator space to develop next-generation aesthetic solutions that address evolving needs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260201157212/en/ “We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions. We’re excited about the potential to bring this innovative neuromodulator to the U.S., offering advanced performance and ease of use and building on our portfolio of neuromodulators that meets the full spectrum of injecto
High-end Aesthetic Brand ‘Lorient’ Gains Global Prestige at IMCAS 20261.2.2026 09:00:00 EET | Press release
Lorient, a premium aesthetic brand, announced that it has drawn global attention at the 27th IMCAS World Congress 2026 in Paris, attracting over 15,000 professionals and demonstrating its leadership in aesthetic innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260131322203/en/ Lorient’s low degree of modification delivers a smooth injection experience and high biocompatibility (Image: Lorient) The highlight was a session led by Dr. Jani van Loghem, a globally revered key opinion leader known for establishing international aesthetic safety protocols. His involvement provided a prestigious validation of the technical excellence of Lorient. Alongside him, prominent Korean medical experts Dr. Won Lee and Dr. Do Young Rhee shared clinical insights that drew widespread praise from the international medical community. Central to the academic discussions was Lorient’s "safety-first" philosophy for its premium HA filler ran
Sharjah Ruler Receives Portugal’s Grand Collar of Order of Camões31.1.2026 19:27:00 EET | Press release
His Excellency Marcelo Rebelo de Sousa, President of the Portuguese Republic, awarded His Highness Sheikh Dr Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, the Grand Collar of the Order of Camões (Grande Colar da Ordem de Camões), the highest sovereign cultural order in Portugal. His Highness is the first Arab figure to receive the Order of Camões and the sixth recipient worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260131119526/en/ Sharjah Ruler receives Portugal’s Grand Collar of Order of Camões (Photo: AETOSWire) The honour was conferred during a ceremony hosted by the Portuguese President at the Presidential Palace in Lisbon. The event was attended by Sheikha Bodour bint Sultan Al Qasimi, Chairperson of the Sharjah Book Authority, alongside senior officials. The ceremony recognised His Highness’s prominent global stature, as a leading figure in culture, intellectual thought and in
Incyte Announces Positive CHMP Opinion for Zynyz ® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)30.1.2026 16:29:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “Today’s positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer.” The positive CHMP opinion was based on data from the Phase 3 POD1UM-303/Inter
Mediawan to Acquire The North Road Company, Creating a New Global Independent Content Platform30.1.2026 14:32:00 EET | Press release
Mediawan, the leading independent European studio led by Pierre-Antoine Capton, co-founded by Capton, Xavier Niel and Matthieu Pigasse, today announced the signing of an agreement to acquire The North Road Company (“North Road”), the preeminent independent U.S.-based studio founded by Peter Chernin. The combination creates one of the world’s largest independent studios with major creative hubs in the five continents and capabilities spanning all genres, formats and audiences. Together, Mediawan and North Road will have a stronger ability to accelerate the development of powerful IP, foster fresh creative synergies through format adaptations and co-production opportunities, and deliver ever greater value to viewers, talent and partners worldwide. The acquisition brings together two of the most dynamic independent studios in the sector with world-class creative talent, premium IP, and the scale to deliver content at the highest level. In an industry undergoing significant consolidation,
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