Teva’s Great White Hope knocked back by Europe
pharmafile | January 27, 2014 | News story | Sales and Marketing | CHMP, EU, MS, Nerventra, Teva
The drug designed to be a follow-up to Teva’s wildly successful Copaxone has been hit by rejection in Europe, leaving its future in doubt.
The multiple sclerosis (MS) treatment known as Nerventra (laquinimod) was knocked back by the European regulator’s safety and efficacy arm the CHMP, over concerns about elevated risk of cancers as well as a possible risk to unborn babies from the drug’s use.
This compounds the misery for the firm over the drug’s marketing path, as in 2011 Teva decided against seeking US approval due to poor clinical trial results. This was a major blow for them firm at the time, as the US would have been the most lucrative market for the drug.
Teva said in a statement that along with partner Active Biotech it would “request a re-examination of the CHMP opinion”.
It added that both firms were focussing on evaluating the CHMP’s review and “will continue to liaise closely with the EMA in working to make Nerventra available as a new treatment option for patients with relapsing-remitting MS in Europe.”
A European rejection now leaves the drug’s future in doubt at a critical time for the firm, as its biggest-selling patented medicine Copaxone is teetering over the patent cliff.
This MS drug has been an excellent workhorse for the Israeli firm, pulling in sales of $4 billion in 2012. But the treatment is set to go off patent this year and will be hit with a series of copycats offering their drugs at a much lower price.
The irony of this will not be lost on Teva, a company that is currently the largest generics drugmaker in the world and has made cheaper version of some of the world’s biggest-selling medicines, including Pfizer’s Lipitor and Viagra.
Teva has already said that is expects to lose $550 million to Copaxone generics this year alone as patents start to slide. Its US rival Mylan has said its copy of Copaxone will be available for sale as soon as the drug’s patent ends in May.
There are also newer MS drugs by Biogen and Novartis that are looking to sweep in to the market, making it more competitive than ever before. Teva will most likely not be able to recreate the major blockbuster sales it once had with Copaxone, even if Nerventra can reach the market.
This all serves to heap more woe onto the firm which looked so strong just a few years ago. But in the past 12 months the company has sought to find $2.5 billion in a series of cost-saving measures, which has included cutting 5,000 jobs from across its business.
The company’s overall strategy and what it will do without Copaxone has not been clear, and last year its former chief executive Jeremy Levin abruptly left the company as questions over its future remained unanswered.
Earlier this month the company named board member Erez Vigodman as its chief executive, but this latest rejection will prove a baptism by fire for the new boss.
Ben Adams
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