Drug Development, Results

AbbVie retreats as Galapagos offers mixed PhII CF data, leaving a major alliance in peril — Vertex shares surge

Galapagos $GLPG outlined some distinctly mixed results from its Phase II study of its C2 corrector GLPG2737 for cystic fibrosis Thursday afternoon, managing to boost the prospects of rival Vertex in the process.

While Galapagos said that the drug — combined with a stable dose of Vertex’s Orkambi — had hit a significant decrease of 19.6 mmol/L (p=0.02) on sweat chloride from baseline, there was only a positive trend in ppFEV1. “The mean absolute change from baseline in ppFEV1 for the GLPG2737 treatment arm versus placebo through day 28 was 3.4% (p=0.08).”

That’s not good. Just listen to Baird’s Brian Skorney:

The lackluster FEV1 performance really makes it tough to imagine Galapagos mounting a relevant competitive campaign against Vertex’s triple combination. Recall, each of Vertex’s third agents showed about a 10% improvement in FEV1 when added to Symdeko. We think Galapagos needed to cross 5% to even have a hope of an argument here but realistically would need to get a ~10% benefit to really be considered a competitive threat. We think the door is closing on Galapagos, which is looking less and less likely to be able to pull out a triple combo that could even hope to match Vertex’s, much less beat it.

And while Galapagos is proceeding with a study of its triple therapy (data due in the next quarter), its big partner AbbVie $ABBV has opted out of a second triple study that had been contemplated, leaving Galapagos “reviewing the future of its CF collaboration with AbbVie.”

AbbVie already pulled out of one alliance with Galapagos, surrendering its interest in filgotinib, which Gilead picked up. The bond can’t be too strong now. AbbVie paid Galapagis $40 million upfront to partner on CF, with more than $300 million in milestones on the table. And AbbVie has walked away from much more than that without a second thought.

Analysts — particularly some of the heavyweights that have long been lined up on Vertex’s side — are likely to see this as another vindication of their star player as the unchallenged leader in CF.  Just a few weeks ago Proteostasis was brushed aside as it tried to offer some competition.

But the market wasn’t having it — then or now.

Piet Wigerinck

Thursday afternoon Vertex shares shot up 9% in after-market trading as investors savored the idea that the big biotech had been left well out in front, with an undisputed lead as it pursues its own triplets. Galapagos, meanwhile, plunged 17% on the news.

But they’re forging ahead, in a fashion.

“The PELICAN trial is the first to evaluate GLPG2737 as a C2 corrector in CF patients on top of Orkambi and showed CFTR on-target activity with GLPG2737 in combination with Orkambi,” said Dr. Piet Wigerinck, chief scientific officer of Galapagos. “We have initiated dosing in the FALCON trial, in which we aim to evaluate higher exposures of GLPG2737 in CF patients and further understand the potential synergistic effect of GLPG2737 on top of our own dual combination compounds.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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