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Mylan receives shock approval of Teva blockbuster

Published on 05/10/17 at 08:26am

Mylan had been knocked back by the FDA in its quest to have its generic version of Copaxone approved earlier in the year, with analysts writting off any approval this year. However, in a surprise move, the FDA moved to give Mylan’s generic the nod in both 40mg and 20mg doses.

The news is particularly unwelcome for Teva, as it has endured a year to forget and only just received a boost with the appointment of a new CEO, in Lundbeck’s Kare Shultz. Now, one of the major tasks he will have to face will be to face early generic competition to the company’s lead product that managed to generate $4.2 billion in revenue last year.

 Teva has already reacted aggressively to the news to state that any launch from Mylan should be considered “at-risk”, as patent disputes are still on going in the courts. In its press release, Teva suggested that it “could subject Mylan to significant damages among other remedies” to block the entry to market of the generics to Copaxone.

For its part, Mylan’s Heather Bresch released a statement on the news: “Mylan has invested tens of millions of dollars over many years to bring this important medicine to market. Providing patients, healthcare providers and caregivers with treatment options is very important when it comes to selecting the right therapy for relapsing forms of multiple sclerosis. Our commitment to the MS patient community extends beyond bringing generic versions of these products to market. Mylan also is offering comprehensive patient support services to help patients access therapy as quickly as possible and adhere to a treatment regimen that fits their needs.”

Many commentators have pointed out the decision comes shortly after the FDA’s Scott Gottlieb had pledged to speed approvals of complex generics. Mylan’s generic is one such product and it will have other companies holding generic competition at bay, such as GSK’s Advair, a little worried that their products may face the same fate.

Shares in both companies reflected how unexpected the decision had been, with Mylan up 19% immediately and Teva down by 14% on the release of the news.

Ben Hargreaves

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