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:
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)
- 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)
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.
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
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