PRESS RELEASE: Merck Initiates a New Phase III Clinical Trial of Safinamide in Early Parkinson’s Disease

Merck Initiates a New Phase III Clinical Trial of Safinamide in Early Parkinson’s Disease

MOTION-Trial Will Evaluate Safety and Efficacy of Two Doses of Safinamide (50 and 100 mg once daily) as Add-on to Dopamine Agonist Therapy in Early Parkinson’s Disease

Darmstadt, November 28, 2007 – Merck KGaA announced today, its division Merck Serono and its partner Newron Pharmaceuticals SpA (SWX: NWRN) initiated the MOTION (SafinaMide add-On To dopamine agonist for early Idiopathic ParkinsON’s disease) study. This study will evaluate the efficacy and safety of two dose regimens of safinamide (50 and 100 mg once daily), as add-on therapy to a stable dose of a single dopamine agonist, compared with dopamine agonist monotherapy. The MOTION study is one of the Phase III trials that constitute the clinical development plan previously discussed with regulatory authorities.

The MOTION study is a six-month (24 weeks), randomized, double-blind, international, Phase III trial. The trial will involve more than 650 patients with early idiopathic Parkinson’s disease (less than five years of disease duration) treated with a stable dose of a single dopamine agonist for at least four weeks. Study participants will be randomized in one of the three arms of the trial (1:1:1), to receive either safinamide 50 mg once daily, safinamide 100 mg once daily or matching placebo tablets, as adjunctive treatment to dopamine agonist therapy.
The primary endpoint of the trial is the change in motor symptoms assessed by the change in the Unified Parkinson’s Disease Rating Scale (1) (UPDRS) Part III score from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, cognitive functions, global clinical status and health-related quality of life.

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.

The UPDRS is one of the most widely used rating scales used to follow the course of Parkinson’s disease.
It is made up of 42 items, scored from 0 to 4, to establish individual patients’ mental status, activities of daily living, motor function and complications of therapy. These are evaluated by interview and clinical observation. Clinicians and researchers alike use the UPDRS and the motor section in particular to follow the progression of a person's Parkinson's disease.

About safinamide
Safinamide, an alpha-aminoamide derivative that is orally administered, 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 potent, 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 sufferer'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.

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Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 30,962 employees in 61 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.