Mylan surprises analysts, Teva with long-delayed Copaxone approvals

Copaxone
On Tuesday, Mylan picked up the market's first approval for a generic of 40-mg Copaxone and the second for a generic of the 20-mg version of the drug.

Mylan’s long been frustrated by delays for a pair of high-profile generic products. But on Tuesday evening, it picked up an approval for one of them—and it came at Teva’s expense.

The FDA greenlighted Mylan’s copy of the Israeli drugmaker’s long-acting, 40-mg version of blockbuster Copaxone—the market’s first—as well as a version of the 20-mg original, the generics giant said. The company may be in line for 180 days of exclusivity on the 40-mg product, it added, but the FDA “has not made a formal determination on exclusivity at this time.”

Teva, for its part, was quick to point out in a statement that "any launch by Mylan of a generic version of Copaxone 40 mg prior to final resolution of the pending patent appeals and other patent litigation should be considered an 'at-risk' launch, which could subject Mylan to significant damages among other remedies." 

RELATED: Mylan's Copaxone copy could face another hold-up with FDA info request

It’s a major lift for Mylan, whose anticipated 20-mg knockoff of the multiple sclerosis star has been conspicuously missing for years. A team of Novartis’ Sandoz and Momenta zoomed ahead with an April 2015 approval of their own version, Glatopa, which last year helped Sandoz’s biopharmaceuticals unit grow 25% to $772 million in sales. And Mylan ran into hurdles with the 40-mg product, too, with the company acknowledging in June that it had received an “information request” from the FDA. That request left some analysts doubtful they’d see a 40-mg generic this year.

“Big win for them (and to be honest, most observers—including myself had written off any generic Copaxone approvals till 2018),” Evercore ISI analyst Umer Raffat wrote in a note to clients.

RELATED: Mylan points finger at FDA for failure to win nods on Advair, Copaxone copies

The Copaxone victory is especially important for Mylan in light of March’s setback for the company’s generic of GlaxoSmithKline respiratory blockbuster Advair. After receiving a complete response letter, company CEO Heather Bresch told investors on Mylan’s second-quarter conference call that Mylan expects “approval delays to persist this year.”

For Teva, meanwhile, the news is a negative surprise at a time when it’s already hurting. As the largest copycat drugmaker, the company is suffering big-time industrywide generics pricing pressure, especially after inking a disastrous $40.5 billion buy for Allergan’s generics unit. And while the company recently heartened investors with the hiring of new chief exec Kåre Schultz, it’s still undergoing a major restructuring, shouldering a big debt burden, and expecting to fall far behind the financial expectations it laid out when 2017 began.

The way Bernstein analyst Ronny Gal sees it, Mylan’s approval will spur a 29-cent earnings per share decline for Teva.

The Copaxone OKs follow right on the heels of new policies FDA Commissioner Scott Gottlieb, M.D., outlined this week to speed the approval of complex generic drugs such as Copaxone.