Setbacks

Teva hit by another PhIII setback on CGRP pain drug fremanezumab, but there’s no pulling back now as rivals race ahead

Teva has already been pushed back to a follow-up shot at the CGRP migraine drug market. Now it’s also lost a Phase III round that could put the company even further behind the market leaders.

The embattled company $TEVA reported this morning that their late-stage program for fremanezumab failed in patients with chronic cluster headaches. They’re abandoning that indication, but plan to push ahead with their study in episodic cluster headaches.

Teva’s late-stage pipeline has been a big problem, with key setbacks in MS. But their CGRP program has been a standout, with Teva looking to leapfrog rivals with a quarterly or monthly injectable. Amgen and their partners at Novartis took the lead with the FDA’s approval of Aimovig, and they priced their drug aggressively, looking to take full advantage of the first-mover position they enjoy.

Analysts have estimated peak sales for Aimovig at about $1.2 billion.

Eli Lilly, meanwhile, has been chomping at the bit with galcanezumab, which is under review at the FDA. They also tried, and failed, to score on chronic clusters, but simultaneously announced that they hit the primary endpoint on episodic cluster headaches. So Teva may yet match up on that score.

Teva, meanwhile, has a September 16 PDUFA date, which could put them ahead of Eli Lilly, expected to get a decision sometime in October. Teva’s manufacturing partner, though, has had some problems, leading to one delay and raising suspicions that another could follow.

Little Alder, meanwhile, is drawing up the rear with eptinezumab, with their timeline on a decision pushed back into next year.

Teva is committed on this drug, and they’re still pushing on follow-up indications. Given the way Phase III migraine data have come in for everyone, with comparable results across the board, the race is already well under way to distinguish themselves in what is shaping up as a crowded market. That’s proving to be difficult, though.

“While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology. We would like to thank the patients and investigators for their participation in the Chronic Cluster Clinical Trial,” said Tushar Shah, the head of global specialty clinical development at Teva.


Image: Teva. SHUTTERSTOCK


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