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 two-year study period. The data further support the safety of switching from Copaxone® to Synthon’s glatiramer acetate.
Following the nine 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 two-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 chief executive officer Jacques Lemmens said:
“With eight 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.”
Full details of the study will be submitted for publication in a peer-reviewed medical journal and presented at future scientific meetings.
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Synthon, with headquarters in Nijmegen, the Netherlands, is an international pharmaceutical company and a leader in the field of generic medicines. The company started its biopharmaceutical franchise in 2007 and is building a promising portfolio of next generation medicines. Synthon is developing rapidly into a specialty pharmaceutical company, focusing on the therapeutic areas of oncology and auto-immune diseases. Synthon products are currently approved by regulatory agencies in over 90 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,500 staff worldwide, and in 2014 it recorded a turnover of EUR 218 million.
GATE was set up following Scientific Advice received from the European Medicines Agency (EMA) with the aim to show equivalence of Synthon’s glatiramer acetate (Synthon GTR) with Teva’s Copaxone® in a well-controlled 3-arm double-blind equivalence study. The open-label part of the study further aimed to provide 2-year efficacy, safety and tolerability data on Synthon’s generic glatiramer acetate and to show safety of switching from Copaxone® to Synthon’s generic. The large-scale, multicenter study consisted of a nine-month double-blind efficacy comparison followed by a 15-month open-label extension and was executed in RRMS patients in Europe (including Russia, Ukraine and Belarus), Mexico, South Africa and the United States.
* Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.