June 19, 2006

Teva drug reduces MS relapses by 75 pct in study

By Bill Berkrot

NEW YORK (Reuters) - Teva Pharmaceutical Industries Ltd's
multiple sclerosis (MS) drug Copaxone reduced relapses by 75
percent in both new patients and those who had not done well on
the older Schering AG medicine Betaseron, according to a large

The open label 805-patient study did not compare the two
drugs but tested Copaxone in both new patients with
relapsing-remitting MS and those who had taken Betaseron, but
discontinued its use for a variety of reasons.

In the study, which appears in the current edition of Acta
Neurologica Scandinavica, about three quarters of the patients
in both groups saw their annual relapse rates reduced by

In addition, 69.5 percent of the new patients and 68.4
percent of those who had previously taken Betaseron remained
relapse free for the study's entire 3 1/2-year duration,
researchers said.

The relapse rates of the Copaxone patients were compared to
their reported relapse rates over the two years prior to
entering the study.

"This study showed that it would be a very good idea to
switch patients to Copaxone if they are not doing well on
Betaseron for whatever reason, be it tolerability or efficacy,"
Dr. Howard Zwibel, medical director of the Baptist Health
Doctors Hospital Multiple Sclerosis Center in Coral Gables,
Florida, said in an interview.

Zwibel, who was the study's lead investigator, cautioned
that the study did not demonstrate the superiority of one drug
over another. But if patients are not doing well on the
interferon drug Betaseron, "about three quarters are going to
do exceedingly well" on Copaxone, he said.

The 247 patients in the study who had failed on Betaseron
received Copaxone for an average of 14.8 months, while the 558
new, or treatment-naive patients, were treated for 20.3 months.

"The 247 patients who had been on Betaseron and stopped,
when they were changed over they did as well as the new
patients who were placed on Copaxone," Zwibel said.

Copaxone, known chemically as glatiramer, does not have
many of the side effects associated with interferon drugs, such
as flu-like symptoms, headaches and potential liver toxicity
issues. The most common side effect in the Copaxone study was
mild or moderate local injection-site reactions.

Copaxone, Teva's most important branded drug, saw sales
jump 29 percent to $329 million in the first quarter of 2006.

Relapsing-remitting multiple sclerosis is the most common
form of the disease in which patients have attacks demonstrated
by physical symptoms that can then improve with medication.