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Data Published in Neurology Showed That Higher Dose of Copaxone,Increased Efficacy in Relapsing-Remitting Multiple Sclerosis (RRMS)

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(R) (glatiramer acetate injection) given daily versus 20 mg of COPAXONE(R) 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(R). 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(R) 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(R) 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 reduced by 75 percent (p<0.0001), compared to 65 percent in patients receiving the 20 mg dose (p<0.0001).

Relapse rates were also lower in patients who received the 40 mg dose of COPAXONE(R), when compared to those who received 20 mg dose (0.34 versus 0.57, respectively). Patients on 40 mg dose of COPAXONE(R) experienced a reduced on-trial mean relapse rate of 77 percent when compared to the
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