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Data on Higher Dose of Copaxone and Data Showing Copaxone is Most,Cost Effective

results of this study, a large-scale Phase III study designed to confirm the higher efficacy of COPAXONE with the increased dose has been initiated. The study, entitled FORTE (FORTy mg Efficacy of glatiramer acetate), was launched July, 2006, in 137 centers across North America, Europe, Argentina and Israel. Recruitment of approximately 1,000 patients is expected to be completed in May 2007. These dossiers, including these data, are expected to be submitted to the U.S. Food and Drug Administration in 2008.


Phase II Study Design and Results


The study was a randomized, double-blind, parallel-group study conducted at 18 centers in the U.S. in 90 patients with RRMS. The study evaluated the effect of 40 mg of COPAXONE (glatiramer acetate injection) given daily versus 20 mg of COPAXONE on disease activity as measured by MRI and clinical relapses, as well as the safety and tolerability of the 40 mg dose over a period of 9 months. Patients that qualified for this study had clinically-definite MS, had experienced a relapse in the previous year, had at least one Gd-enhancing lesion at screening visit, and had a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5. Patients were randomized in equal numbers to receive either 40 mg or 20 mg of COPAXONE . All patients underwent an MRI at baseline, and then at months 3, 7, 8 and 9. Neurological examinations were performed at screening, baseline, and again at months 3, 6 and 9, and suspected on-trial relapses were confirmed at an unscheduled visit within 7 days.


COPAXONE 40 mg showed a 38 percent greater reduction of inflammatory disease activity as measured by mean cumulative number of Gd-enhancing T1 MRI lesions versus COPAXONE 20 mg (p=0.0898). The benefit of the 40 mg dose was observed in as soon as 3 months (p=0.005) through MRI measurement. When compared to baseline numbers, the risk of having MRI activity (Gd-enhancement) in the 40 mg group at months 7, 8 and 9 was redu
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