Synthon just released the results of its Phase III GATE study using a generic version of glatiramer acetate. Teva’s name-brand version of glatiramer acetate, Copaxone, was the top-selling multiple sclerosis drug of 2013. Glatiramer acetate is FDA approved for the treatment of relapsing-remitting multiple sclerosis and modulates the immune system by acting as a decoy for myelin and preventing hyperactive immune cells from attacking neurons in the brain and spinal cord. Jeffrey Cohen, MD, Chair of the GATE Steering Committee commented, “The mechanism of action of Copaxone is not fully understood and the resulting complexity of developing a generic alternative/version is broadly acknowledged.” To be able to manufacture and sell the generic version, Synthon needed to prove that their formulation was clinically equivalent to Copaxone.
The GATE trial is a large-scale, multicenter study that consists of two arms: a completed nine-month double-blind efficacy comparison of the two drug versions against placebo and an ongoing 15-month open-label extension in Europe, Mexico, South Africa, and the United States. In the completed arm, nearly 800 patients with active relapse-remitting multiple sclerosis were randomized to receive 20 mg/ml of Synthon’s glatiramer acetate or Copaxone or a matching placebo.
At the time points of 7, 8, and 9 months after the start of treatment, the primary endpoint of brain lesions seen by MRI showed that either drug formulation reduced the severity of lesions compared to placebo. Moreover, the incidence of relapse and disability were reduced by either drug and adverse reactions were comparable between formulations. During the second arm, all drug-receiving patients are receiving the generic version, and it is expected the endpoints will further prove the safety and efficacy of long-term treatment and support the safety of switching treatments.
Looking at the results, Synthon’s chief executive officer Jacques Lemmens asserted, “The data gathered during the double-blind part of the study present a solid basis for the regulatory submission in Europe in order to make an equivalent alternative to available to patients suffering from multiple sclerosis.” This has impressive meaning for the growing population of multiple sclerosis patients–as the first generic version of an approved multiple sclerosis product, Synthon’s glatiramer acetate may alleviate some of the burden of the costs of multiple sclerosis, which can range from $30,000 – $60,000 per patient per year.