Teva's three-times-a-week Copaxone formulation cleared in US

The FDA approved Teva's new formulation of Copaxone (glatiramer acetate) allowing the multiple sclerosis therapy to be administered subcutaneously three-times-a-week rather than once daily, the company reported. The drugmaker indicated that the new formulation is available for shipping to distribution outlets immediately, and will be available to patients within days.

According to Teva, the approval was based on results from the Phase III GALA study, which included more than 1400 patients. The trial showed that Copaxone dosed at 40 milligrams three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favourable safety and tolerability profile in patients with relapsing-remitting MS.

Copaxone generated estimated sales of $4.2 billion in 2013 but is set to face generic competition in the US later this year after a Supreme Court justice declined a request from the company for a stay of an appeals court ruling that shortened patent protection on the product from September 2015 to May 2014. Teva said in December last year that if generic versions of Copaxone launch in the US on June 1, its own annual sales of the drug will be between $3.1 billion and $3.2 billion.

Teva has previously said that it hopes to switch as many as half of the patients taking daily Copaxone to the three-times-a-week formulation, which has patent protection until 2030. However, the company is also facing competition from new oral treatments for MS, such as Biogen Idec's Tecfidera (dimethyl fumarate), Novartis' Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), with analysts estimating that sales of Copaxone will fall 56 percent by 2016.

For related analysis, see ViewPoints: Do Teva's Copaxone sums add up? and Spotlight On: Teva steps up efforts to protect Copaxone brand as Mylan calls foul as well as ViewPoints: Can Teva's lifecycle strategy for Copaxone reduce generic threat?

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