Teva asks FDA to raise the bar on new Copaxone copies

By Carly Helfand Oct 31, 2016 11:56am

Teva may be at a court’s mercy when it comes to IP protection for its long-lasting multiple sclerosis therapy, Copaxone. But that doesn’t mean the company is just sitting around.

The Israeli drugmaker has delivered a 124-page argument to the FDA with the goal of convincing the regulator that approval requirements for new Copaxone generics should be stricter than those for knockoffs of Teva’s 20-mg formulation.

The Petah Tikva-based company collected eight batches each of old Copaxone and Sandoz/Momenta generic Glatopa, making the point that the knockoffs have a “high hydrophobicity fraction” not present in the branded med. The way Teva sees it, those differences could lead to issues Copaxone itself doesn’t produce.

But while “Teva's document is well-written, fact-based and strikes the right tone,” the document presents just “one side’s view of the data,” Bernstein analyst Ronny Gal wrote in a Monday note to clients. And on top of that, “we would argue Teva links to 'clinical relevance' are not strong.”

Still, it’s possible that the “FDA will pause here to consider the data more carefully,” and a delay could certainly benefit the under-pressure drugmaker.

The possibility of generic competition has been seriously weighing on Teva’s shares as of late, sending them down to levels last seen back when former CEO Jeremy Levin was at the helm.

And it’s not just investors that are bracing for a Teva loss: Several analysts also expect the court to go the way the U.S. Patent and Trademark Office’s Patent Trial and Appeals Board recently did, upturning patents on the key moneymaker.

It’s not the first time Teva has turned to the FDA to try to throw up a hurdle in its rivals’ paths. It filed multiple citizens petitions trying to stall Glatopa in the first place, though those ultimately proved unsuccessful.

- see the document

Generics Copaxone Glatopa Teva Pharmaceutical