Drug Development

Gilead tackles a big PhIII program for blockbuster hopeful filgotinib

Gilead $GILD has embarked on an ambitious Phase III program for filgotinib, one of the most closely-watched drugs now in the late-stage pipeline for rheumatoid arthritis.

The storied Galapagos drug, which had been dumped by AbbVie only to be quickly picked back up in a rich deal with Gilead, is being put through three late-stage studies – dubbed FINCH 1, 2 and 3 – which will test two doses in more than 3,000 patients.

“The FINCH program, led by our collaboration partner Gilead Sciences, is designed to enable a comprehensive evaluation of 100 mg and 200 mg filgotinib once daily in early stage to biologic-resistant RA patient populations,” said Piet Wigerinck, the CSO at Galapagos. “Preparations are well underway to also initiate studies with filgotinib in Crohn’s disease and ulcerative colitis in Q4 of this year.”

Analysts have pegged peak potential sales of filgotinib at $2 billion to $3 billion-plus per year, though it’s a busy space with a number of rival therapies in the clinic.

Last fall, AbbVie axed a collaboration it had in place with Galapagos for their JAK1 inhibitor filgotinib (GLP0634), saying it preferred to take their in-house program for ABT-494 into Phase III for arthritis. But Gilead, in search of beefing up its late-stage prospects, saw a potential blockbuster in the wind. The big biotech swooped in with a $725 million upfront – including a $425 million equity stake – late last year to partner on the drug. And Gilead added $1.35 billion in potential milestones.

Gilead has done of couple of big collaborations like this, putting an emphasis on finding late-stage drugs that can help it maintain revenues swollen by its windfall of profits from its hep C portfolio. It’s still repeatedly tapped as a likely candidate for M&A deals before the end of the year.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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