Dutch drug developer Synthon BV today announced success in its Phase III clinical trial of glatiramer acetate, a generic version of Teva Pharmaceutical Industries Ltd.s' (NYSE: TEVA; TASE: TEVA) Copaxone. Syntheron says that the GATE study to test the equivalence with Copaxone met the main endpoint in patients with relapsing remitting multiple sclerosis, and that it is the only Phase III study conducted to date with a generic version of Copaxone that was found to have an equivalent efficacy and safety profile to Teva's drug.
In the GATE study 796 patients with active RRMS were randomized to daily injections of Synthon’s glatiramer acetate (20 mg/ml), Copaxone (20 mg/ml) or matching placebo for a double-blind 9-month treatment period. Safety analyses showed a comparable incidence of reported adverse reactions between both active glatiramer acetate groups.
In December 2013, Teva said that if a generic version of Copaxone is launched, the company's earnings per share would fall to $4.20-4.50 in 2014, but that if no generic version of Copaxone is launched, its earnings per share would be $4.80-5.10. The company said that it did not expect a material reduction in Copaxone sales in 2014, even if a generic version was launched. The optimistic scenario of no generic launch predicted $3.6-3.7 billion in Copaxone sales in 2014, and the pessimistic scenario, with a generic launch, predicted $3.1-3.2 billion in Copaxone sales.
Published by Globes [online], Israel business news - www.globes-online.com - on March 27, 2014
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