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Copaxone (Glatiramer) Effective in Reducing Multiple Sclerosis Progression Over 10 Years, Study to be Extended: Presented at AAN

MS Patients Who Withdrew From Therapy During Long-Term Follow Up Demonstrated Increased Disease Progression

KANSAS CITY, MO -- April 28, 2004 -- Relapsing-remitting multiple sclerosis (RRMS) patients who remained on CopaxoneŽ (glatiramer acetate injection) therapy for an average of 10 years experienced significantly less progression of disability than patients who withdrew from the open-label, long-term follow-up study. Two hundred and thirty-two patients (92 percent of 251 originally randomized) receiving Copaxone from randomization or open-label switch were included in the long-term follow up. According to data presented late yesterday at the 56^{th[/sup>] annual meeting of the American Academy of Neurology, more than 90 percent of the 108 patients still on Copaxone did not show evidence of disease progression to an EDSS of 6.0 on the Expanded Disability Status Scale (EDSS). In comparison, 50 percent of the 47 patients who withdrew from Copaxone therapy after an average of 4.5 years progressed to this score. The other 77 patients who withdrew from the study were not available for long-term follow up.}

"This is the longest-running continuous assessment of a drug treatment in RRMS patients, and this data continues to substantiate the long-term clinical benefits of Copaxone," said Dr. Kenneth P. Johnson, professor of neurology, University of Maryland, and director of the Maryland Center for MS. "The slowing of disability in the ongoing Copaxone group was especially pronounced at an average of 10 years on therapy."

Average EDSS scores for the continuously followed Copaxone (glatiramer acetate injection) patients, at the start of therapy, four years later, and 10 years later, were 2.56, 2.55, and 3.06 compared to 2.84, 3.77, and 5.11 in those patients who withdrew (p<0.0001 at year 10). When patients reach an EDSS score of 6.0, they require intermittent or unilateral (one-sided) constant assistance, such as a cane, crutch, or brace, to walk a distance of 100 meters with or without resting.

The open-label study is a long-term follow-up to an original pivotal safety and efficacy trial, which is now in its 12^{th[/sup>] year. In the original placebo-controlled study which lasted approximately 30 months, a 32 percent reduction in relapse rates was seen compared to placebo, and 81.6 percent of patients were stable or improved in terms of EDSS scores. As patients moved into the long-term open-label follow-up phase, in all those receiving Copaxone, relapse rate reductions from a baseline of 72 percent, 86 percent, and 85 percent were observed after six, eight, and 10 years of follow up, respectively. Similarly, percentages of patients remaining stable or improving from baseline on EDSS scores were 69.3, 65.3, and 64.4. During years four through 10, the relapse rate was approximately 0.2 per year, or one relapse every five years.}

"We can not overestimate the importance of following patients systematically in an organized study where patients are evaluated every six months for a long period of time," said Dr. Johnson. "By extending the observation period to 15 years, we will continue to learn more about how MS progresses and how Copaxone may slow this progression."

Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. 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 42 countries worldwide, including the United States, Canada, Australia, Israel, and all the European countries. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, Copaxone is marketed by Teva Neuroscience.


SOURCE: Teva Neuroscience

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