Novartis' Gilenya tops Teva giant Copaxone in head-to-head MS study

Novartis headquarters
Novartis' Gilenya is the first disease-modifying multiple sclerosis drug to beat out Teva’s Copaxone in a head-to-head study at reducing relapses. (Wikimedia Commons/Andrew/Flickr)

Teva’s injectable multiple sclerosis drug Copaxone has done a remarkably good job hanging on to market share in the face of oral competitors, generics and more. But Novartis aims to change that. 

On Wednesday, the Swiss drugmaker said its pill Gilenya had topped the Teva blockbuster at preventing relapses in a head-to-head trial in patients with relapsing remitting multiple sclerosis. At the 0.5-mg dose, Gilenya cut the relapse rate by 40.7% compared with the 20-mg dose of Copaxone, the company said.

In doing so, it became the first disease-modifying MS drug to beat out Teva’s drug, lead study investigator Bruce Cree, M.D., Ph.D., said in a statement. Relapses are “a key measure of disease activity and a significant burden for patients,” he added.

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RELATED: Teva's Copaxone holds its own in wake of Mylan's generic price cut

If Novartis is aiming to snatch share from its rival, though, there’s one problem with the new data set: Gilenya trumped the 20-mg version of Copaxone, which most Copaxone patients have already moved away from. The reason? Teva introduced a long-lasting, 40-mg version to preserve its market share before its patents on the original version expired.

Since then, Novartis’ Sandoz has introduced a 20-mg competitor, and Mylan has come at the Israeli drugmaker with knockoffs of both the long- and short-acting versions of the drug. It’s even knocked down its list prices, too, providing a steep discount to the Teva original.

And still, Copaxone has stood its ground, maintaining its “share in the U.S. in terms of volume,” Teva CEO Kåre Schultz said on the company’s second-quarter earnings calls in August. Brendan O'Grady, the company’s commercial head in North America, added that Teva is “on target” to reach $1.5 billion in sales of the drug for 2018.

RELATED: Riding on patent office win, Novartis takes Gilenya generics fight to court

Meanwhile, it may not be long before Gilenya has to face down generic competitors of its own. A formulation patent on the product has already been struck down twice, which puts the drug at risk of losing exclusivity in 2019 unless Novartis can prevail in court.