JPM: Gilead leans on data, focus to launch filgotinib into jam-packed RA market

As Gilead gears up to launch filgotinib, the JAK inhibitor it has under FDA review in rheumatoid arthritis, it knows full well it’s prepping for entry into a crowded market. But it’s got three priorities in mind for the launch, and it thinks those tactics can help set the drug apart from numerous rivals.

The first? Get filgotinib’s clinical data—which Gilead’s execs called potentially “best in class”—out as quickly as possible as Gilead rolls the drug out to the market, commercial chief Johanna Mercier said during a breakout Q&A session at last week’s J.P. Morgan Healthcare Conference.

Feedback from physicians has so far been very positive, she said, and because only 20% of RA patients today reach remission, “clinical data need to drive what we do.”

Priority No. 2 has to do with focus. “We can’t be everything to everyone,” Mercier said, especially considering how many players are already duking it out in the field. “We need to be clear on where we’re going to focus—and where we focus, we play to win.”

Lastly, Gilead will be thinking “a little bit more holistically” about the product—i.e., beyond the RA indication. The company foresees a total of five indications launching in the next four years, so it’s keeping not only the short term but also the medium-to-long term in mind.

RA is currently dominated by anti-TNF giants, including AbbVie’s Humira. But “we’re prepared for this,” Gilead CEO Daniel O’Day told investors at a presentation preceding the Q&A session. “We’ve brought in talent from outside the organization” to complement the talent already at Gilead “to be successful for this launch,” he noted.

But RA isn’t the only competitive arena the Big Biotech intends to target with filgotinib. It’ll take aim at ulcerative colitis next, with a phase 3 readout coming in the first half of this year. If it can successfully make it to market, it’ll have to contend with the likes of Johnson & Johnson’s Stelara and Pfizer’s Xeljanz.

Gilead, though, sees solo filgotinib therapy as just the beginning of a new phase for the company in inflammation. Encouraged by the candidate’s tolerability profile, it’s already looking ahead to potential combinations with the drug, execs said during the breakout.

Gilead also has “a broad inflammation portfolio” making its way through the pipeline that “has been significantly enhanced” by the Big Biotech’s 2019 partnership with Galapagos, O’Day said.

Jan 21, 2020

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