{"id":457169,"date":"2021-03-15T07:00:38","date_gmt":"2021-03-15T11:00:38","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=457169"},"modified":"2021-03-15T07:00:38","modified_gmt":"2021-03-15T11:00:38","slug":"newron-and-zambon-sign-agreement-for-potentially-pivotal-study-with-safinamide-in-parkinsons-disease-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/newron-and-zambon-sign-agreement-for-potentially-pivotal-study-with-safinamide-in-parkinsons-disease-patients\/","title":{"rendered":"Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson\u2019s Disease Patients"},"content":{"rendered":"

<\/p>\n

Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide <\/i>in Parkinson\u2019s Disease Patients<\/b><\/p>\n

Global study to evaluate the reduction of<\/i>levodopa-induced dyskinesia (PD LID)<\/i><\/p>\n

MILAN–(BUSINESS WIRE<\/a>)–
\nNewron Pharmaceuticals S.p.A. (\u201cNewron\u201d) (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. (\u201cZambon\u201d), 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<\/i> in Parkinson\u2019s disease patients with levodopa induced dyskinesia (PD LID).\n<\/p>\n

\nUnder 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.\n<\/p>\n

\nThe 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<\/i> in key markets. Safinamide<\/i> has previously been approved for the treatment of Parkinson\u2019s disease as add-on therapy to levodopa\/carbidopa experiencing \u201coff\u201d 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<\/i> 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<\/i> in 2020.\n<\/p>\n

\nRavi Anand, CMO of Newron, said: \u201cPrevious 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<\/i>.\u201d\n<\/p>\n

\nPaola Castellani, CMO and R&D Head of Zambon, added: \u201cSince 2015, thousands of Parkinson\u2019s disease patients around the world have benefited from safinamide\u2019s 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.\u201d <\/i><\/p>\n

\nParkinson\u2019s 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.\n<\/p>\n

References:
\n
<\/b>Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease.<\/a> Borgohain, Rupam; Szasz, Jozsef; Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H et al. (2014)
\n
Movement disorders : official journal of the Movement Disorder Society<\/i> vol. 29 (10) p. 1273-80.
\n
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\u2019s Disease and Movement Disorders, Sydney, Australia, June 16-20, 2013.\n<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210314005022\/en\/<\/a><\/span><\/p>\n

Newron
\n<\/b>
Stefan Weber – CEO
\n
+39 02 6103 46 26 – pr@newron.com<\/a><\/p>\n

UK\/Europe: <\/b>Simon Conway \/ Natalie Garland-Collins
\n
FTI Consulting
\n
+44 20 3727 1000 – SCnewron@fticonsulting.com<\/a><\/p>\n

Switzerland: <\/b>Valentin Handschin, IRF Reputation
\n
+41 43 244 81 54 – handschin@irf-reputation.ch<\/a><\/p>\n

Germany\/Europe: <\/b>Anne Hennecke, MC Services
\n
+49 211 52925222 – anne.hennecke@mc-services.eu<\/a><\/p>\n

USA: <\/b>Paul Sagan, LaVoieHealthScience
\n
+1 617 374 8800, Ext. 112 – psagan@lavoiehealthscience.com<\/a><\/p>\n

Zambon
\n<\/b>
Valentina Saffioti –Global Pharma Communication
\n
+39 0266524508 – valentina.saffioti@zambongroup.com<\/a><\/p>\n

KEYWORDS:<\/b> Italy Europe<\/p>\n

INDUSTRY KEYWORDS:<\/b> Health General Health Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n","protected":false},"excerpt":{"rendered":"

Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson\u2019s Disease Patients Global study to evaluate the reduction oflevodopa-induced dyskinesia (PD LID) MILAN–(BUSINESS WIRE)– Newron Pharmaceuticals S.p.A. (\u201cNewron\u201d) (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. (\u201cZambon\u201d), 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\u2019s 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 … <\/p>\n

Continue reading “Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson\u2019s Disease Patients”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-457169","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nNewron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson\u2019s Disease Patients - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/newron-and-zambon-sign-agreement-for-potentially-pivotal-study-with-safinamide-in-parkinsons-disease-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson\u2019s Disease Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson\u2019s Disease Patients Global study to evaluate the reduction oflevodopa-induced dyskinesia (PD LID) MILAN–(BUSINESS WIRE)– Newron Pharmaceuticals S.p.A. (\u201cNewron\u201d) (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. (\u201cZambon\u201d), 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\u2019s disease patients with levodopa induced dyskinesia (PD LID). 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