COPAXONE: Teva Initiates Phase III Study to Confirm Increased Efficacy of Higher Dose of Glatiramer Acetate for the Treatment of Relapsing-Remitting MS; Study to Confirm Phase II Results Showing Reduced Relapses and Lesions :
"Teva Pharmaceutical Industries (NASDAQ: TEVA) announced today the initiation of a large Phase III study designed to confirm the positive results from the Phase II study which compared a new higher dose of 40 mg/day dose of glatiramer acetate (GA) to the currently approved COPAXONE(R) (GA) 20 mg/day, whose efficacy and safety have been well established by three pivotal trials and over a decade of experience and clinical research. The study, called FORTE - FORTy mg Efficacy of glatiramer acetate - is beginning the enrollment of approximately 1,000 patients in 160 centers across North America, Europe, Argentina and Israel

The results of the initial nine-month, randomized, double-blind, parallel-group Phase II study were presented at the 58th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, CA, April 1-8, 2006. Patients taking the higher dose of GA had a 38 percent greater reduction in mean cumulative number of gadolinium (Gd)-enhancing lesions as measured by magnetic resonance images (MRI) of the brain compared with those taking the COPAXONE(R) (GA) 20 mg/day dose. In addition, compared to annual relapse rate prior to entry, patients taking GA 40 mg/day experienced a reduced mean on-trial relapse rate of 77 percent whereas patients taking COPAXONE(R) (GA) 20 mg/day experienced a 62 percent reduction. GA 40 mg/day was well-tolerated with a safety profile similar to the currently COPAXONE(R) (GA) 20 mg/day.


"The Phase II study results are very promising and suggest that the established efficacy of COPAXONE(R) can be increased even further with this next generation of GA," said Israel Makov, President and Chief Executive Officer of Teva Pharmaceutical Industries Ltd. "The initiation of the FORTE study is part of our commitment to MS patients to develop improved therapies that combine superior efficacy and excellent safety," Makov added.

About the Study

The FORTE study is a 12-month, multinational, multicenter, randomized, parallel-group, double-blind study. Patients will be equally randomized into one of two groups: 40 mg GA once daily or COPAXONE(R) (GA) 20 mg once daily. The study objectives include comparing the efficacy and safety of daily subcutaneous injections of 40 mg/day GA to that of COPAXONE(R) (GA) 20 mg/day in RRMS patients. Confirmed relapses and adverse events will be monitored throughout the study. Patients completing the 12-month phase will continue in the study for an additional 12-month, open-label phase in which all subjects will receive 40 mg/day GA.

Patients and health care providers interested in learning more about the study can visit www.clinicaltrials.gov and enter the trial's identifier code of NCT00337779 for more information......"