Synthon Announces Successful Outcomes from the Open-label Extension of the Phase III GATE Study of Synthon’s Glatiramer Acetate

Synthon announces that data from the open-label extension of the Phase III GATE study of the company’s generic glatiramer acetate in patients with relapsing remitting multiple sclerosis (RRMS) demonstrate that efficacy, safety and tolerability were maintained over the entire 2-year study period. The data further support the safety of switching from Copaxone to Synthon’s glatiramer acetate.

Following the 9-month double-blinded period of the GATE study, in which 796 patients were treated with Synthon’s generic glatiramer acetate (GTR), Copaxone or placebo, patients initially treated with Synthon GTR continued their treatment for an additional 15 months to complete the planned 2-year study period.

Patients from the Copaxone and placebo groups were successfully switched over to treatment with Synthon GTR for a 15-month period. Results from this part of the study confirmed continued efficacy, measured by MRI parameters and clinical relapses, as well as the continued safety and tolerability during a two-year treatment period with Synthon GTR.

The data further support the safety of switching active therapy from Copaxone to Synthon’s generic glatiramer acetate. Efficacy, safety and tolerability profiles remained unaffected throughout the duration of the extension study.

Synthon announced results from the GATE study in March 2014 demonstrating that Synthon’s glatiramer acetate had an efficacy and safety profile that was equivalent to Copaxone®. The open-label data will provide further support for the evaluation of Synthon’s glatiramer acetate by regulatory authorities, prescribing neurologists and payers.

Synthon’s CEO Jacques Lemmens said: “With 8 years of thorough research work and over EUR 100 million invested in the development of our glatiramer acetate, we have clearly established equivalence, in both pre-clinical and clinical studies.”

“The open-label results constitute the last piece of the puzzle, which demonstrates equivalence in efficacy and safety, and a safe switch from Copaxone to our glatiramer acetate.”

“The MS community is in need of affordable medication. Synthon’s glatiramer acetate is the only clinically validated alternative with two years of safety and efficacy data, and could provide an affordable, efficacious and safe alternative not only for Copaxone, but also for other first-line treatments such as interferons and orals. This would allow for substantial savings on MS medication for patients and payers, without losing out on efficacy and safety.”