Milan, Italy, April 13, 2011 – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, and its partner Merck Serono, a division of Merck KGaA, Darmstadt Germany, announced today that new data on safinamide will be presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) taking place from April 9 to 16, in Honolulu, Hawaii. Safinamide is currently being assessed in Phase III trials as add-on treatment to dopamine agonist or levodopa in early to late stage Parkinson’s disease (PD).
“The data presented at the upcoming AAN meeting will further contribute to the substantial body of knowledge about safinamide,” said Dr. Bernhard Kirschbaum, Merck Serono’s Head of Global Research and Development. “We are committed to provide new therapy options for patients with Parkinson’s disease, an area with significant remaining medical need.”
“Newron is very excited about the results to be presented at the AAN and we expect that results of the ongoing phase III trials will further substantiate the emerging therapeutic profile of safinamide,” said Dr. Ravi Anand, Newron’s Chief Medical Officer.
The following abstracts have been accepted for presentation at the 63rd AAN Annual Meeting:
Safinamide
Late-breaking poster presentation
- First long-term (2-year) controlled study to evaluate treatment with safinamide as add-on to levodopa in patients with Parkinson’s disease and motor fluctuations
(poster P05.287, Wednesday, April 13, 2011, 2:00 PM)
Platform presentation
- Safinamide reduces levodopa-induced dyskinesia and extends ON time over 7 days of daily dosing in the MPTP primate model
(presentation S33.002, Wednesday, April 13, 2011, 3:15 PM)
About safinamide
Safinamide is an alpha-aminoamide that is currently being developed by Merck Serono and Newron as an add-on therapy to dopamine agonists or levodopa in patients with early or late-stage Parkinson’s disease. It is believed to have both dopaminergic and non-dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro. Studies are ongoing to better understand safinamide’s actions in patients with Parkinson’s disease.
About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson’s disease (PD). As per the agreement signed with Newron in 2006, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications. Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron’s additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection and NW-3509 for the treatment of schizophrenia. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.
Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride), (Egrifta™, tesamorelin), as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.
With an annual R&D expenditure of over € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of € 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
For more information, please visit www.merckserono.com or www.merck.de
For more information, contact:
Media
Italy
Luca Benatti - CEO
Phone: +39 02 6103 4 626
E-mail: pr@newron.com
UK/Global media
Julia Phillips
Financial Dynamics
Phone: +44 (0) 20 7269 7187
Switzerland
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40
Investors and analysts
Stefan Weber - CFO
Phone: +39 02 6103 46 30
E-mail: ir@newron.com
Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s 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’s 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 “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, 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.
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Juliet Edwards
Assistant
Financial Dynamics
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