Teva

Israel's Teva Pharmaceuticals Industries released results of the FORTE trial evaulating a double-dosage of its multiple sclerosis drug Copaxone (glatiramer acetate), that the firm hoped would extend the patent for the standard dose in due to expire in 2014. However, the higher dose failed to show any greater efficacy.

The randomized, double-blind study was designed to assess the efficacy, safety and tolerability of a 40mg dose of glatiramer acetate, as compared to the currently approved Copaxone 20mg dose. It included 1,155 patients with relapsing-remitting multiple sclerosis. The trial's primary clinical outcome measure was rate of confirmed relapses. The 40mg dose showed similar safety and tolerability, but also comparable efficacy.

Wachovia analyst Michael Tong believed Teva was not likely to file a New Drug Application for the higher dose this year, but that the outcome of the trial would have little effect on the firm's financial results in the short term. Nonetheless, shares in Teva fell 6% to $44.15 on the day of the announcement, July 7. It says it will continue to analyze the study results to better understand the effect of the 40mg dose on patients. The company is also evaluating the use of glatimer acetate for additional indications.