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ANA: Agilect (Rasagiline Mesylate) Appears to Provide Significant Symptom Benefit In Parkinson's Disease as Monotherapy and Adjunct Therapy Data From Two Studies Showed Benefit for Early and Moderate-To-Advanced Patients TORONTO, ON -- October 4, 2004 -- Agilect® (rasagiline mesylate) taken once- daily significantly improved symptoms of Parkinson's disease (PD) both as initial monotherapy in patients with early PD and as adjunct treatment to levodopa in moderate-to-advanced patients, according to a poster presented at the American Neurological Association (ANA) annual meeting. "In both trials involving early and more advanced patients, treatment with rasagiline showed significant benefit on Parkinson's disease symptoms throughout the course of the disease," said Ira Shoulson, M.D., professor of neurology at the University of Rochester School of Medicine and principal PSG investigator of the TEMPO and PRESTO trials. "The demonstrated benefits, safety and ease of dosing suggest that rasagiline could be a promising new treatment for Parkinson's disease." Teva Neuroscience, Inc. and Eisai Inc. will co-promote Agilect in the United States, once approved by the FDA, as part of a long-term strategic alliance between Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd. The data presented are based on the change in Unified Parkinson's Disease Rating Scale (UPDRS) scores recorded in two Agilect clinical trials, TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients (TEMPO) and Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "OFF" (PRESTO). The UPDRS is a research tool commonly used to measure a PD patient's ability to perform motor and mental tasks and activities of daily life. The studies, conducted in the United States and Canada by the Parkinson Study Group (PSG), included more than 875 patients. The TEMPO trial examined the effects of once-daily 1 mg or 2 mg Agilect (rasagiline mesylate), or placebo in patients with early PD who did not yet require dopaminergic therapy. The PRESTO trial evaluated the effects of once-daily 0.5 mg or 1 mg Agilect, or placebo when added to optimized levodopa/carbidopa and other concomitant anti-PD treatments such as dopamine agonists or entacapone in patients with moderate to advanced PD who were experiencing motor fluctuations. Over the 26 weeks in the TEMPO and PRESTO trials, the overall treatment benefit of Agilect 1 mg, as measured by total UPDRS, was statistically significant compared to placebo in both the TEMPO (P < 0.0001) and PRESTO (P = 0.0084) studies. The UPDRS motor score in the TEMPO study and the UPDRS motor score during "ON" in the PRESTO study improved significantly, versus placebo (TEMPO [P < 0.0001] and PRESTO [P = 0.0011]). The differences between Agilect 1 mg and placebo for both tremor and slowness of movement were statistically significant in TEMPO (P = 0.0020; P < 0.0001) and PRESTO (P = 0.0021; P = 0.0493). And, in PRESTO, UPDRS rigidity scores improved in the Agilect 1 mg group compared to placebo (P = 0.0239). Agilect was well tolerated in both trials. In TEMPO, adverse events seen more frequently in the Agilect 1 mg group (at least 2 percent greater than placebo) were headache, dyspepsia, depression, flu syndrome and rash. In PRESTO, adverse events seen more frequently in the Agilect 1 mg group (at least 2 percent greater than placebo) were dyskinesia, accidental injury, nausea, weight loss, constipation, postural hypotension, arthralgia, vomiting, dry mouth and rash. Parkinson's disease is a degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement and impaired balance. An estimated one million Americans have the disease, which usually affects people over the age of 50. Agilect is a novel, potent, second-generation, selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement. A new drug application for Agilect for the treatment of PD was submitted to the U.S. Food and Drug Administration (FDA) Sept. 5, 2003. Indications are being sought for once-daily Agilect as a monotherapy in early PD and as an adjunct to levodopa in moderate to advanced disease. Agilect® (rasagiline mesylate) is a registered trademark of Teva Pharmaceutical Industries Ltd. SOURCE: Teva Neuroscience, Inc. SOURCE: Doctor's Guide - Oct 04 8:55 AM http://tinyurl.com/6q68e * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn