\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, 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). Positive results from the study could result in a label extension for safinamide<\/i>, subject to regulatory approval.\n<\/p>\n
\nUnder the agreement with its partner Zambon, 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 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
\nJonathan Rubin, CMO of Supernus Pharmaceuticals, stated: \u201cWe welcome the agreement reached between our partners and look forward to the next steps towards the initiation of the study. Supernus recognizes the substantial potential benefits a label extension covering PD LID, if approved by the FDA, would offer to the patients.\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
About safinamide References: \nAnand 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 About Parkinson\u2019s disease and Levodopa (L-dopa) Induced Dyskinesia (LID) References: About Newron Pharmaceuticals About Supernus Pharmaceuticals, Inc. Important Notices View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210315005352\/en\/<\/a><\/span><\/p>\n For more information, please contact USA- <\/b>Paul Sagan, LaVoieHealthScience KEYWORDS:<\/b> Italy Europe<\/p>\n INDUSTRY KEYWORDS:<\/b> Health Other Science Research Pharmaceutical Science Biotechnology<\/p>\n
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<\/b>Safinamide is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition and blocking of voltage dependent sodium channels which leads to modulation of abnormal glutamate release. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24-month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor fluctuations (ON\/OFF time) without increasing the risk of developing troublesome dyskinesia. This effect may be related to its dual mechanism acting on both the dopaminergic and the glutamatergic pathways. Safinamide is a once-daily dose and has no diet restrictions due to its high MAO-B\/MAO-A selectivity. Zambon has the rights to develop and commercialize Safinamide<\/i> globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize safinamide. The rights to develop and commercialize Safinamide<\/i> in the USA have been acquired by Supernus Pharmaceuticals. Safinamide is commercialized under different brand names: Onstryv\u00ae<\/i> in Canada, Equfina\u00ae<\/sup><\/i>in Japan and South Korea and Xadago\u00ae <\/i>in the rest of the world.\n<\/p>\n
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<\/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)
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Movement disorders : official journal of the Movement Disorder Society<\/i> vol. 29 (10) p. 1273-80.\n<\/p>\n
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<\/b>PD is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer\u2019s disease, affecting 1-2% of individuals aged \u2265 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on L-dopa. L-dopa remains as the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, more than 40% of patients experience L-dopa-Induced Dyskinesia, involuntary and non-rhythmic 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. As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the \u201coff-time\u201d effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms.\n<\/p>\n
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<\/b>BMC Oertel. European Handbook of Neurological Management, Vol 1, Chapter 14 & 15, 2011.
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NICE PD guideline, 2006.\n<\/p>\n
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<\/b>Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Safinamide<\/i> has received marketing authorization for the treatment of Parkinson\u2019s disease in the European Union, Switzerland, the USA, Australia, Canada, Brazil, Colombia, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron\u2019s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit: www.newron.com<\/a><\/b><\/p>\n
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<\/b>Supernus Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, hypomobility in Parkinson\u2019s disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson\u2019s disease, epilepsy, depression, and rare CNS disorders. For more information, please visit www.supernus.com<\/a>.\n<\/p>\n
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<\/b>This document contains forward-looking statements, including (without limitation) about (1) Newron\u2019s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron\u2019s anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as \u201cwill,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cproject,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cbelieve,\u201d \u201ctarget,\u201d and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and\/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements, and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange, where the shares of Newron are listed. This announcement is not an offer for sale of securities in the United States, Canada, Australia or Japan or any other jurisdiction where such an offer or solicitation would otherwise be unlawful. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Newron does not intend to register any of its securities in the United States or to conduct a public offering of its securities in the United States. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of this document shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.\n<\/p>\n<\/p>\n
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Newron
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Stefan Weber \u2013 CEO
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+39 02 6103 46 26 – pr@newron.com
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+1 617 374 8800, Ext. 112 – psagan@lavoiehealthscience.com<\/a><\/p>\n
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