sptrap2000

http://biz.yahoo.com/prnews/030821/lnth002_1.html

Press Release Source: Teva Pharmaceutical Industries Ltd.


Studies Show Copaxone(R) Is Effective in RRMS Regardless of Disease
Severity
Thursday August 21, 8:00 am ET

Meta-analysis of three studies confirms COPAXONE(R) (glatiramer
acetate injection) reduces disability accumulation and relapse rate in
mild, moderate, or severe relapsing-remitting multiple sclerosis


KANSAS CITY, Mo., Aug. 21 /PRNewswire-FirstCall/ -- The first
published meta-analysis on COPAXONE® confirms the effectiveness of the
drug on reducing disability accumulation and the relapse rate in
patients with relapsing-remitting multiple sclerosis (RRMS). In
addition, researchers validated that this effect remained regardless
of whether the patients had mild, moderate, or severe RRMS when they
entered the studies.

"We wanted to see if the severity of a person's MS had any effect on
how well COPAXONE® worked," said Filippo Martinelli Boneschi, M.D.,
Department of Neuroscience, Scientific Institute and University H. San
Raffaele, Milan, Italy. "What we found was that COPAXONE® was
effective on patients who entered clinical trials with higher Expanded
Disability Status Scale (EDSS) scores, as well as those who began with
lower scores. In fact, COPAXONE® tended to have greater efficacy in
patients with more severe disability and fewer relapses in the two
years preceding clinical trial entry."

The study was published in the August issue of Multiple Sclerosis. It
evaluated data from three randomized, double-blind, placebo-controlled
trials (Bornstein et al., Johnson et al., and Comi et al.) that had
shown COPAXONE® was effective in reducing relapses. A meta-analysis is
an important study in determining whether the pooled data from several
studies can still support the findings of single studies.

There were 540 patients total in all three clinical trials included in
the study. Researchers looked at two main clinical outcomes --
reduction of the relapse rate and slowing of accumulated disability.

Approximately a one-third reduction of the total number of on-trial
relapses was observed in patients receiving COPAXONE® (glatiramer
acetate injection) who had a median time to the first relapse of 322
days vs. a median time to the first relapse of 219 days seen in those
receiving placebo. This reflects a treatment effect of 32 percent (p =
0.01).

"Individually, studies for the immunomodulating drugs showed a relapse
rate reduction of about a third. This study confirms that finding in
COPAXONE®," said Dr. Martinelli Boneschi.

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
U.S., 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.