SOURCE: Teva Neuroscience

June 30, 2005 08:00 ET

COPAXONE® May Have Ability to Protect Against Axonal Injury Over the Long-Term in Relapsing-Remitting Multiple Sclerosis

Additional Long-Term Efficacy in Both Clinical and MRI Parameters Also Highlighted at European Neurological Society Meeting

KANSAS CITY, MO -- (MARKET WIRE) -- June 30, 2005 -- New data presented at the European Neurological Society Meeting (ENS) demonstrated key clinical and magnetic resonance imaging (MRI) effects of COPAXONE® (glatiramer acetate injection) in the treatment of relapsing-remitting multiple sclerosis (RRMS). Results highlighted sustained beneficial effects on cerebral axonal injury and the value of starting COPAXONE® treatment early to slow the accumulation of long-term disability as measured by the Expanded Disability Status Scale (EDSS).

MRS results suggest beneficial effect of COPAXONE® on cerebral axonal injury

Brain n-acetylaspartate (NAA) levels, a marker of neuronal integrity and function, are measured by magnetic resonance spectroscopy (MRS). An increase in brain NAA levels relative to creatinine (NAA/Cr ratios) indicates a recovery of injured nerve cells or neurons in the brain. Preventing or minimizing damage to nerve cells is critical in reducing long-term disability in multiple sclerosis.

The open-label study involved 18 RRMS patients (15 of whom were followed for three years). Assessments included EDSS scores and annual MRI/MRS scans. Additionally, four untreated controls were followed for the first two years. Two of these patients began therapy with COPAXONE® for the third year of the study. The data were presented by Omar Khan, M.D., associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University.

Unlike the gadolinium-enhanced MRI, increases in NAA levels, as measured by MRS, may indicate reversal of axonal loss, which strongly correlates to improved clinical disability.

Dr. Khan commented on the results, "COPAXONE® treatment led to increased NAA/Cr ratios, suggesting improved cerebral axonal recovery in RRMS patients, indicating a potential benefit on the pathways of electrical conduction in the brain." COPAXONE® (glatiramer acetate injection) sustained this improvement over a three-year period, compared to pretreatment baseline and untreated controls. Further, in two of the four untreated control patients who began COPAXONE® treatment after two years of no treatment, an increase in NAA concentrations was observed during the third year of the study, compared to the continued decline observed in the two patients who remained untreated. "These MRS data suggest an action of COPAXONE® in the central nervous system (CNS), resulting in a sustained beneficial effect on cerebral axonal injury. No other approved treatment for RRMS has been shown to have a beneficial effect on MRS scans over a three-year period. This study also supports the emerging concept of COPAXONE® as a neuroprotective agent in addition to helping reduce relapses. Additional research investigating the potential neuroprotective attributes of COPAXONE® is ongoing," explained Dr. Khan.

Early intervention with COPAXONE® slows the accumulation of long-term disability

Marco Rovaris, M.D., Neuroimaging Research Unit, Department of Neuroscience, Scientific Institute and University of Ospedale San Raffaele, Milan, presented long-term, open-label data (at almost six years) in patients who had originally participated in a blinded MRI study which demonstrated the efficacy of COPAXONE®.

Two hundred and twenty-four patients entered the nine-month placebo-controlled study. Of these, 142 entered an open-label extension in which all patients were treated with COPAXONE®. Patients continued to be assessed for an average of 5.8 years. Patient visits involved clinical assessments and included EDSS scoring.

A higher proportion of patients who were continuously on COPAXONE® (glatiramer acetate injection) (n=73) did not reach significant disability as defined by EDSS scores equal to or greater than six compared to those who were on placebo for the first nine months, then switched to COPAXONE® (n=69) (p=0.03). Significant disability in the analysis was the point at which patients require intermittent or unilateral (one-sided) constant assistance, such as a cane, crutch, or brace. These results suggest early initiation of COPAXONE® in patients with active RRMS may have a positive impact on long-term disease evolution by slowing the progression to significant disability.

About COPAXONE®

Current data suggest COPAXONE® is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all the European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE® (glatiramer acetate injection). COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd.

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