Teva says higher dose of Copaxone increases benefit in MS patients

By Elaine Rigoli

Tampa, Fla., April 5 - A new, higher dose of Copaxone (glatiramer acetate injection) showed promising results in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS), Teva announced Wednesday.

A nine-month, randomized, double-blind, parallel-group phase 2 study of 90 patients comparing a 40 mg dose of Copaxone to the currently approved 20 mg dose showed a 38% greater reduction in mean cumulative number of gadolinium (Gd)-enhancing lesions, according to a news release.

The trial used magnetic resonance images of the brain as a measurement in patients taking the higher dose compared with those taking the 20 mg dose.

In addition, patients taking Copaxone 40 mg experienced a reduced mean on-trial relapse rate of 77% when compared to annual relapse rate prior to entry, as compared to 62% with Copaxone 20 mg, the release said.

The company said it will conduct a phase 3 study, designed to confirm the higher efficacy of Copaxone with the increased dose, during the second half of 2006.

This new data was released at the annual meeting of the American Academy of Neurology in San Diego.

Teva, based in Jerusalem, Israel, develops, manufactures and markets generic human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

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