Novartis, Momenta receive FDA approval for first generic version of Teva's Copaxone

Novartis' Sandoz unit announced Thursday FDA approval for the first generic version of Teva's multiple sclerosis therapy Copaxone (glatiramer acetate). The once-daily drug, which will be sold as Glatopa, was developed in collaboration with Momenta Pharmaceuticals, and is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.

"Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," commented Peter Goldschmidt, president of Sandoz US.

Momenta noted that under the terms of an agreement, initially forged with Novartis in 2006, the latter will pay Momenta as much as $140 million in regulatory, commercial and sales-based milestones for Glatopa, including a payment of $10 million due upon sole FDA approval of the therapy and another $10 million payment for the first commercial sale.

The approval of the generic version comes after the US Supreme Court ordered an appeals court to reconsider its decision to invalidate Teva's patent for Copaxone after determining that the lower court used the wrong approach in its ruling. For related analysis, see ViewPoints: Sorting through the fallout from the SCOTUS ruling on generic Copaxone.

Commenting on the news, Teva spokesperson Denise Bradley noted that the company planned for the possibility that a generic version of Copaxone could reach the market. In December 2014, the company estimated that the early entry of generic Copaxone could depress operating income by $30 million to $50 million per month. Meanwhile, Sanford C. Bernstein analysts remarked "Teva has been quite realistic about the risk to Copaxone."

Momenta noted that Sandoz is still evaluating launch timing of the drug. Evercore ISI analyst Umer Raffat suggested that despite prior court rulings, Sandoz may prefer to wait until September to launch Glatopa, adding that it is "unclear if Novartis interested in doing an at-risk launch ahead" of patent expiry.

In January last year, the FDA approved Teva's new formulation of Copaxone allowing the multiple sclerosis therapy to be administered subcutaneously three-times-a-week rather than once daily. The Israeli drugmaker, which priced the new formulation of Copaxone at a discount to the once-daily version, has switched around two-thirds of patients to the new formulation of the therapy. For related analysis, see ViewPoints: Why delaying generic Copaxone remains key for Teva, despite the success of its 'switch' strategy.

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