Teva asks FDA to raise the bar on new Copaxone copies

Copaxone

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.

Free Webinar

What could you do with real-time supply chain information at your fingertips?

Interested in complete supply chain real-time data visibility? Unlock productivity with digital workflows, manage plants inventory with real-time supply chain information and enable faster decision-making with data visualization with pci | bridge. Register today!

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

Related Articles:
Is CEO Vigodman to blame for Teva's recent turmoil? Some investors think so
Teva shares rival Mylan's pain as both hit two-year lows
Teva at court's 'mercy' in key Copaxone patent trial: Analysts
One, two, three, gone: Teva loses third patent on new Copaxone formula
Teva's Copaxone finally succumbs to copycats, putting a drag on 2015 sales
Mylan, Momenta, Sandoz join assault on Teva's new-and-improved Copaxone
Teva takes another swing at generic Copaxone with new FDA petition

Suggested Articles

Implementing data integration strategy in your commercialization breaks down traditional healthcare silos and improves patient outcomes.

Roche and Blueprint's RET inhibitor Gavreto has won FDA go-ahead to treat certain types of thyroid cancer, leveling the field with Lilly's Retevmo.

CDMO Sterling Pharma Solutions is plotting a buyout of a U.K.-based antibody-drug conjugate specialist in a new bid at the next-gen cancer fighters.