Nijmegen, Netherlands, 09 October 2014 – Synthon today announced that its Abbreviated New Drug Application (ANDA) for a three-times-a-week 40 mg/mL glatiramer acetate has been accepted for review by the FDA. On final approval by the FDA, Synthon believes it is eligible for 180 days of marketing exclusivity under the provisions of the Hatch-Waxmann act.
In 2011 Synthon also filed an ANDA for 20 mg/mL glatiramer acetate which is currently under review by the FDA. The European regulatory authorities are also reviewing the eCTD for this product. Earlier in 2014, Synthon announced that the company’s glatiramer acetate met the main endpoint of a late-stage study in patients with relapsing remitting multiple sclerosis (RRMS). The Phase III Glatiramer Acetate clinical trial To assess Equivalence with Copaxone®* (GATE) is to-date the only Phase III study conducted with a generic version of Copaxone® and has demonstrated an equivalent efficacy and safety profile for Synthon’s glatiramer acetate compared to Copaxone®.
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 auto-immune diseases and oncology. Synthon products are currently approved by regulatory agencies in over 80 countries worldwide and marketed through strategic partnerships and – in dedicated areas – through direct sales. Synthon employs about 1,400 staff worldwide, and in 2013 it recorded a turnover of EUR 215 million. For more information, go to www.synthon.com.
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 study that was also designed to show superiority of the two active treatment groups over placebo. The primary endpoint of the study was the number of T1 gadolinium enhancing brain lesions on MRI assessed after 7, 8 and 9 months of treatment. Other outcomes included the incidence of MS relapses, disability, patient reported tolerability and immunogenicity. The large-scale, multicenter study consists of a nine-month double-blind efficacy comparison followed by a currently ongoing 15-month open-label extension and runs in Europe (including Russia, Ukraine and Belarus), Mexico, South Africa and the United States.
* Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.