Positive outcome in EU decentralised procedure for Copaxone 40 mg (glatiramer acetate) three times a week formulation for multiple sclerosis-Teva

Teva Pharmaceutical Industries Ltd.,has announced that it has received a positive outcome in the decentralized procedure for its new, three-times-a-week Copaxone (glatiramer acetate) 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis (RMS). The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe who were involved in the procedure. Granting of national authorizations will happen in the near future.

The three-times-a-week Copaxone 40 mg/ml formulation will allow for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60 percent, while maintaining the known benefits of once daily Copaxone 20 mg/ml.

Comment: The FDA approved Copaxone 40 mg on 29 January 2014 and it has been the aim of Teva to switch patients from the Copaxone 20 mg formulation because its US patent is due to expire in September 2015. The FDA approved, this week, a generic version of the 20 mg formulation called Glatopa from Sandoz + Momenta Pharma, but the timing of its entry to the market is clouded by intense litigation. An American analyst has pointed out that Teva has now switched over 67% of Copaxone 20 mg patients to the 40mg formulation, which has patent protection until 2030.