Merck Serono, Newron Pharmaceuticals: Safinamide Shows Promising Ph3 Results Against Dyskinesia

GENEVA, April 13, 2011 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner Newron Pharmaceuticals S.p.A., today announced 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)

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 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(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alfa), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride), (Egrifta(TM), tesamorelin), as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over EUR 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 EUR 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.

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