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October 10, 2012

Teva reports positive data from Phase III GALA study

Teva Pharmaceutical Industries has reported positive data from its Phase III glatiramer acetate low-frequency administration (GALA) study designed to evaluate glatiramer acetate, the therapeutic agent in copaxone (glatiramer acetate injection).

Teva Pharmaceutical Industries has reported positive data from its Phase III glatiramer acetate low-frequency administration (GALA) study designed to evaluate glatiramer acetate, the therapeutic agent in copaxone (glatiramer acetate injection).

The glatiramer acetate 40mg/ml injection administered three times a week significantly reduced annualised relapse rates (ARR) by 34.4% (p<0.0001) compared to placebo in more than 1,400 patients with relapsing-remitting multiple sclerosis.

Teva Pharmaceutical Industries chief scientific officer and Global R&D president Dr. Michael Hayden said: "The GALA study demonstrates Teva’s ongoing commitment to the research and development of products aimed at meeting the specific needs of the RRMS community."

Patients treated with GA 40mg/1 ml versus placebo have shown a significant 34.4% reduction in the cumulative number of new and enlarging T2 lesions and a significant 44.8% reduction in the cumulative number of gadolinium-enhancing (GdE) legions.

GA 40mg/1ml demonstrated a favourable safety and tolerability profile and the overall frequency of adverse events was similar to those observed in the placebo group.

Wayne State University School of Medicine Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory director and Department of Neurology professor and interim chair Dr. Omar Khan said the GALA study was aimed at evaluating an alternative dosing regimen of copaxone, an RRMS therapy that physicians and patients have relied on for almost two decades.

"The results demonstrate that GA 40 mg/1 ml injected three times weekly has the potential to provide an alternative therapeutic option for patients with RRMS, offering a higher dose of GA at a reduced injection frequency to improve patient experience, without compromising efficacy or safety," Dr. Khan added.

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