New copaxone data

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Longest Running Multiple Sclerosis Trial Shows COPAXONE® Effective

Over 10 Years -- Study to Be Extended to 15 Years

MS Patients Who Withdrew From COPAXONE® Therapy During Long-Term

Follow Up Demonstrated Increased Disease Progression

KANSAS CITY, MO -- (MARKET WIRE) -- 04/28/2004 -- Relapsing-

remitting multiple sclerosis (RRMS) patients who remained on

COPAXONE® (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 56th 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. P.

, professor of neurology, University of land, and

director of the land 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 12th 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. . " 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. "