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Teva drug reduces MS relapses by 75 pct in study

By Bill Berkrot Mon Jun 19, 2:11 PM ET

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 study.

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 Copaxone.

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.

Orig link:
http://news.yahoo.com/s/nm/20060619/hl_ ... axone_dc_1

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Dunmann.

Dunman,

I wouldn't pay too much attention to the data from any drug company that uses an open label trial to "prove" the efficacy of their product.

Copaxone has historically provided only about a 30% reduction in relapses over placebo in the double-blind clinical trials. This 75% number is nothing but a marketing ploy to try and increase sales. We will start to see a lot of this with the re-approval of Tysabri and the competitor drug companies all try and keep their market share of MS drug sales.

Harry