Jefferies
Gilead Sciences (GILD): Filgotinib Still Solid In Key Crohn's Maintenance Phase, Though Details Scant
Rating HOLD
Price Target $101.00
Price $101.74
Bloomberg NASDAQ: GILD
Key Takeaway
This afternoon, GILD's partner GLPG reported additional top-line data from the ph.II filgotinib Crohn's study, which appeared to show encouraging maintained benefits without any new safety issues, though with few specifics. More detailed data (likely at a medical mtg) and regulatory feedback on acceptable doses will be important to fully elucidate its promise; we see the program contributing $1.3B in probability-weighted out-yr revenues to GILD.
Recall prior induction data had shown promise at the 10 week endpoint. Recall, 10-week "induction" data from the first part of this ph.II FITZROY study in Crohn's disease, released in December 2015, showed a statistically significant improvement in clinical remission rate and meaningful clinical response for pts on 200mg of the drug vs. placebo, with no known safety issues.
New longer-term filgotinib data, though short on specifics, appears to continue to support the drug’s promise. Today, after market close, GLPG reported 20-week filgotinib data from the study, which incorporates the second 10-week "maintenance" phase, and we had the opportunity to speak with the company about the data. Notable findings were that 1) clinical responses for patients originally on 200mg continued from weeks 10 to 20; 2) non-responders from the initial placebo arm who then received 100mg in the subsequent 10 weeks showed improvement in remission; 3) safety was clean and consistent across the study’s duration, with no GI perforation, cancers, or deaths.
Several key questions will be important to explore, when data are reported at a medical meeting: Whether patients switching from placebo to 100mg had remissions/responses in their first 10 weeks on drug that are as high as those originally randomized to 200mg will be important to learn, as this would dictate whether the lower 100mg dose might be acceptable going forward. The degree of maintenance of response/remission during the second 10 weeks for patients initially responding to 200mg will also be an important element of the product's potential profile, as will the degree to which such remissions/responses are maintained for patients staying on 200mg, compared to dropping down to 100mg, or converting to placebo. The dose dependence is important because recall that FDA had excluded the 200mg dose from GLPG's prior RA study due to preclinical tox findings; GLPG/GILD held an end-of-ph.II meeting with FDA March/April providing substantial additional preclinical/clinical data supporting filgotinib's potential safety at 200mg, and when the minutes become available in coming weeks, we expect to learn whether FDA will be amenable to this dose.
Program advancing smoothly in joint GILD/GLPG hands. A ph.III program in RA is expected to begin this quarter, and GILD hopes to initiate a ph.III Crohn's study, as well as potential additional trial(s) in UC, later in 2016. While the RA indication is somewhat crowded with a high bar set by baricitinib, the market remains large, and IBD indications in our view are a considerable opportunity considering the unmet need and lack of potential oral options like filgotinib.
Jefferies LLC