Newron Pharmaceuticals: Data on Safinamide to Be Presented at the 14th MDS Meeting

Milan, Italy, June 10, 2010 – 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, today announced that new data on safinamide will be presented at the 14th annual meeting of the Movement Disorder Society (MDS), an international congress of Parkinson’s disease and movement disorders taking place June 13 to 17, in Buenos Aires, Argentina. Safinamide is an investigational oral therapy 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 results presented at the 14th MDS congress will contribute to improve the understanding of the mechanism of action of safinamide,” said Bernhard Kirschbaum, Merck Serono’s Head of Global Research and Development. “We believe that safinamide has the potential to become one of the first add-on therapies to treat early to late stage Parkinson’s disease.”

The following abstracts have been accepted for the poster presentation at the 14th MDS annual meeting:

Poster presentations

- Safinamide reduces levodopa-induced dyskinesia in MPTP-lesioned primates while prolonging anti-parkinsonian efficacy (Poster 680, June 16, 2010, 1:30-3 p.m. local time; Guided Poster Tour 2, June 14, 2010: 2-3:30 p.m. local time) - MOTION (safinaMide add-On To dopamine agonist in early Idiopathic ParkinsON’s disease) study design: a 24-week, double-blind, placebo-controlled study of the efficacy and safety of safinamide

(Poster 319, June 15, 2010, 1:30-3 p.m. local time)

- Effect of safinamide on depressive symptoms in patients with mid-late stage Parkinson’s disease (Poster 324, June 15, 2010, 1:30-3 p.m. local time)

- Safinamide as add-on to levodopa improves motor function without worsening dyskinesia in patients with mid-late Parkinson’s disease

(Poster 359, June 15, 2010, 1:30-3 p.m. local time; Guided Poster Tour 13, June 17, 2010, 1:30-3 p.m. local time)

- SETTLE study design: a 24-week, double-blind, placebo-controlled study of the efficacy and safety of safinamide as add-on therapy to levodopa in patients with Parkinson’s disease (Poster 378, June 15 2010, 1:30-3 p.m. local time)

- Cognitive deficits in patients with mid- to late-stage Parkinson’s disease (Poster 404, June 15, 2010, 1:30-3 p.m. local time)

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. (www.newron.com) 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 is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron’s additional projects are in development 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.
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