First Phase III Clinical Trial Results of Safinamide in Advanced Parkinson’s Disease to Be Presented at the Movement Disorder Society 13th International Congress

GENEVA, Switzerland - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner Newron Pharmaceuticals S.p.A. (SWX: NWRN) announced today that detailed results of the first Phase III clinical trial of safinamide as adjunctive treatment in mid- to late-stage Parkinson’s disease (PD) (Study 016) will be presented at the Movement Disorder Society’s 13th International Congress of Parkinson’s Disease and Movement Disorders to be held in Paris, France, from June 7-11, 2009.

The late-breaking abstract, entitled “Efficacy and safety of safinamide in patients with Parkinson’s disease experiencing motor fluctuations: results of a 6-month Phase III, randomized, double-blind, placebo-controlled study”, has been accepted for a presentation that is scheduled for Wednesday, June 10, 2009, from 12:30 to 14:30 CET at the session “Late Breaking Abstracts”, abstract number LB-14, in Hall Maillot, Level 2, at Le Palais de Congrès in Paris, France.

Merck Serono has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications, as per the agreement signed with Newron in 2006.

About the Movement Disorder Society (MDS)

The Movement Disorder Society (MDS) is an international professional society of clinicians, scientists, and other healthcare professionals, who are interested in Parkinson’s disease, related neurodegenerative and neurodevelopmental disorders, hyperkinetic movement disorders, and abnormalities in muscle tone and motor control. The Movement Disorder Society was founded in 1985 on the initiative of Professors Stanley Fahn and C. David Marsden, whose leadership and vision guided the expansion of clinical expertise and research in this field. This not-for-profit organization merged in 1992 with the International Medical Society for Motor Disturbances. Publication of the journal Movement Disorders began in 1986, and the first International Congress was held in 1990.

About safinamide

Safinamide, an alpha-aminoamide derivative that is formulated for oral administration, is currently being developed by Merck Serono and Newron as an add-on treatment for patients with Parkinson’s disease. Safinamide is believed to have a novel dual mechanism of action based on the enhancement of the dopaminergic function (through reversible inhibition of monoamine oxidase-B [MAO-B] and dopamine uptake) and reduction of glutamatergic activity by inhibiting glutamate release.

About Parkinson’s disease

Parkinson’s disease is a degenerative disorder of the central nervous system that often impairs the patient’s motor skills and speech. Parkinson’s disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement (akinesia). The primary symptoms are the results of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high-level cognitive dysfunction and subtle language problems. Parkinson’s disease is both chronic and progressive. It is estimated that more than 3 million people in the industrialized countries suffer from Parkinson’s disease.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD 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 alpha), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) 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 around 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 autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,700 employees in 60 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

Source: Merck Serono

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