COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients.

New Data from the Longest Prospective Study Employing Annual Magnetic Resonance Spectroscopy Imaging (MRS) Indicate Impact of COPAXONE[R] on Axonal Injury and Recovery

KANSAS CITY, Mo. -- Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that COPAXONE([R]) (glatiramer acetate injection) may slow the neurodegenerative tissue damage that is a key aspect of multiple sclerosis (MS) disease pathology. Results of the longest, prospective study of annual brain proton MRS imaging in relapsing-remitting multiple sclerosis (RRMS) patients suggested a beneficial effect of COPAXONE([R]) treatment on cerebral axonal injury and recovery.

"These data reinforce the findings of previous studies showing that in addition to reducing relapses in RRMS patients over the long term, COPAXONE([R])may have the unique ability to slow or prevent neurodegenerative processes by reducing axonal injury and promoting axonal recovery within the central nervous system, and that this benefit is sustained over time," said Omar Khan, M.D., Wayne State University and lead investigator of the study.

In MS, measuring brain n-acetylaspartate (NAA) levels relative to creatine (Cr) (NAA/Cr ratios) via MRS is a method of assessing axonal injury caused by the disease. Decreased levels of brain NAA/Cr ratios are a marker of neuronal damage or degeneration and also correlate strongly to clinical disability; an increase in brain NAA/Cr ratios indicates a recovery of injured nerve cells or neurons in the brain. This study involved annual blinded MRS analyses of NAA/Cr of patients (n=22), over four years.

"Patients in this study who remained on COPAXONE([R])(glatiramer acetate injection)experienced an increase in mean NAA/Cr, pointing not only to the treatment's effect on slowing accumulation of brain tissue damage as measured by MRS, but to its effect on the recovery of damaged brain tissue," said Khan. "Measuring changes in NAA/Cr ratio throughout the course of the disease is of increasing interest to the MS research community because of data demonstrating its correlation with accumulated disability, pointing to the potential for MRS imaging to serve as a surrogate marker for both disease progression and therapeutic response in clinical practice."

About the Study

In this study, investigators performed annual conventional magnetic resonance imaging (MRI) as well as MRS measurements on treatment-naive RRMS patients (n=22), 18 of whom commenced treatment with COPAXONE([R]) and four who remained untreated by choice. Over the four years of the study, blinded annual MRS analyses of NAA/Cr were carried out in a volume-of-interest (VOI) centered on the entire corpus callosum, which also allowed for the examination of the normal appearing white matter (NAWM) within the corpus callosum. At baseline, patients' (n=18) mean NAA/Cr ratios (SD) for the entire VOI was 1.97 ( 0.24) and was 2.075 ( 0.30) in the NAWM. After four years of follow up, 15 of the 18 patients in the treated group were still receiving COPAXONE([R])and demonstrated an increase to a mean NAA/Cr of 2.21 ( 0.16) in the VOI and 2.27 ( 0.20) in the NAWM.

About COPAXONE([R])

Current data suggest COPAXONE([R]) (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE([R]) is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE([R]) are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

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

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

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