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Pfizer and Synthon Join for Potential Generic Treatment of Multiple Sclerosis

Generic version of Copaxone currently under FDA review

Pfizer Inc. has acquired the exclusive U.S. commercialization rights to Synthon’s potential generic version of glatiramer acetate (Copaxone, Teva Pharmaceuticals) for the treatment of relapsing–remitting multiple sclerosis (RRMS).

In November 2011, Synthon (a pharmaceutical company specializing in generic medications) filed an abbreviated new drug application (ANDA) with the FDA for a once-daily 20-mg/mL formulation of glatiramer acetate. In early 2014, Synthon also filed an ANDA for a three-times-a-week 40-mg/mL formulation of glatiramer acetate. The company believes that its glatiramer acetate 40-mg/mL filing may be eligible for 180 days of shared marketing exclusivity under the provisions of the Hatch–Waxman Act.

Under the terms of an agreement between Pfizer Inc. and Synthon, Pfizer will have exclusive rights to commercialize both dosage formulations of glatiramer acetate in the U.S.

The phase III, controlled, double-blind GATE (Glatiramer Acetate clinical trial To assess Equivalence with Copaxone) showed the equivalence of Synthon’s glatiramer acetate with Copaxone in patients with RRMS. The large-scale, multicenter study consisted of a 9-month double-blind efficacy comparison followed by a 15-month open-label extension. The open-label part of the study further aimed to provide 2-year efficacy, safety, and tolerability data on generic glatiramer acetate and to demonstrate the safety of switching from Copaxone to the generic version.

MS is an unpredictable, often disabling disease of the central nervous system that interrupts the flow of information within the brain, and between the brain and body. Signs and symptoms of the disease vary widely, depending on the amount of damage involved and on which nerves are affected. Symptoms range from numbness and tingling to blindness and paralysis. These problems may come and go, or they may persist and worsen over time. RRMS, the most common form of MS, is characterized by episodes of inflammatory activity (relapses), followed by remission. RRMS affects approximately 85% of patients with newly diagnosed MS.

According to the National Multiple Sclerosis Society, most people with MS are diagnosed between the ages of 20 and 50 years, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide. In the U.S., the number of people with MS is estimated to be approximately 400,000.

Source: Pfizer; August 3, 2015. 

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