Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe
Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone®* for the treatment of relapsing remitting multiple sclerosis (RRMS). All 29 member states included in the decentralized procedures supported approval of the product.
The authorities’ approval formally acknowledges that Synthon’s glatiramer acetate is regarded therapeutically equivalent to the reference product based on the Quality, Non-Clinical and Clinical data submitted in the application.
Synthon conducted a large-scale, multicenter Phase III study, known as GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone®). Results of the study demonstrate equivalence in efficacy and safety and support the safety of switching active therapy from Copaxone® to Synthon’s glatiramer acetate. Synthon is the only company to have performed such a study for glatiramer acetate and to obtain regulatory clearance in Europe.
Synthon’s chief executive officer Jacques Lemmens said: “This approval is testimony to the quality and similarity of our glatiramer acetate, which is the only clinically validated alternative to Copaxone® in Europe. It is a landmark for Synthon and for MS patients throughout Europe, who are in anticipation of a more affordable treatment for this chronic, unpredictable, and debilitating disease.”
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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 1,600 staff worldwide, and in 2015 it recorded a turnover of EUR 267 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 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. After completing the 9-month double-blind phase of the trial and meeting the primary endpoint in 2014, the 15-month open-label part of the GATE trial was successfully completed in early 2015. Results obtained from this part of the study confirmed continued efficacy – measured by MRI parameters and clinical relapses – as well as safety and tolerability of 2-year treatment with Synthon glatiramer acetate. The data further support the safety of switching active therapy from Copaxone® to Synthon’s generic glatiramer acetate, as efficacy, safety and tolerability profiles remain unaffected.
Scientific posters summarizing the safety and tolerability results as well as the radiological endpoints were presented in October 2015 during the 31st ECTRIMS conference in Barcelona by Professors Jeffrey Cohen (Mellen Center, Cleveland, USA) and Frederik Barkhof (VU Medical Center, Amsterdam, the Netherlands), and will be published in a peer-reviewed journal later this year. On 12 October 2015, the manuscript describing the main outcome of the GATE trial was published by the high ranking journal ‘JAMA Neurology’ as original research paper entitled “Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis. A Randomized Clinical Trial”.
* Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.