BioCentury
ARTICLE | Clinical News

Synthon reports data for generic Copaxone

March 28, 2014 12:50 AM UTC

Synthon B.V. (Nijmegen, the Netherlands) said once-daily injections of Synthon's generic glatiramer acetate for nine months met the primary endpoint of equivalence to Copaxone glatiramer acetate in the 796-patient Phase III GATE trial to treat relapsing-remitting multiple sclerosis (RRMS). Equivalence was measured as a reduction in the number of T1 gadolinium-enhancing brain lesions on MRI scans from baseline at seven, eight and nine months.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) markets Copaxone in the U.S. and shares European rights with Sanofi (Euronext:SAN; NYSE:SNY). Teva loses U.S. exclusivity for Copaxone on May 24. The company, which reported $4.3 billion in 2013 worldwide sales for the product, was up $0.26 to $49.14 on Thursday. ...