First phase III clinical trial results of Safinamide in advanced Parkinson’s disease to be presented at the Movement Disorder Society’s 13th International Congress

MILAN, Italy – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, 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), conducted with its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, 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 to be administered orally, 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 Newron Pharmaceuticals

Newron Pharmaceuticals S.p.A. ( is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Newron is undertaking phase III trials with safinamide for the treatment of Parkinson’s disease (PD) in conjunction with its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications. Newron recently initiated SERENA, a potentially pivotal study with ralfinamide in patients with neuropathic low back pain (NLBP). There are no approved drugs for the treatment of NLBP, an indication experienced by about 55 m patients in the USA, Europe and Japan. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.

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