Teva is facing the first direct competition to its big-selling multiple sclerosis (MS) therapy Copaxone in the US after a generic from Novartis and Moneta was cleared by the FDA.
The generic – which will be sold as Glatopa by Momenta and Novartis’ Sandoz subsidiary – is fully substitutable for Copaxone (glatiramer acetate) in the treatment of patients with relapsing forms of MS, according to the FDA.
“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research (CDER).
“Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product,” she added.
The approval does not necessarily mean MS patients in the US can expect Glatopa to be available imminently, as Teva is still trying to preserve market exclusivity for Copaxone in the US courts and launch right now would be at-risk.
The US Supreme Court recently ordered an appeals court to look again whether a Teva patent on the drug that expires in September is valid – which had previously been invalidated – and this process remains ongoing. Analysts have suggested Sandoz has enough of a lead over other generics to allow it to hang fire for the patent expiry or the resolution of litigation.
For Teva, even a few months delay is significant. Copaxone contributed $4.24bn out of its total revenues of $20.27bn last year, with the US market accounting for around three quarters of the product’s sales. Faced with the loss of exclusivity on its cash-cow, Teva has already introduced a series of measures both to reduce costs and expand its product portfolio.
A streamlining initiative carved around $600m from its cost base last year – with another $500m expected to be saved this year – and the company is also seeking out M&A opportunities.
At the end of last month it announced a $3.5bn agreement to buy central nervous system (CNS) therapy specialist Auspex, although some investor are said to be pushing for a bigger, transformative merger deal.
Teva has also tried to defend its franchise with the development of a new formulation that can be injected three times a week, rather than once a day as is the case with Glatopa and the first Copaxone formulation.
The Israeli company said recently it had managed to migrate around two-thirds of existing Copaxone patients in the US to the new formulation.
For Momenta, the approval activates a $10m milestone payment from Novartis, with another $10m due when Glatopa makes its first commercial sale.