Gilead’s Dan O’Day pulls the plug on the lion’s share of their filgotinib collaboration as the FDA erects a high safety barrier. What went wrong?
Five years after Gilead plunked down $725 million in cash to partner with Galapagos on filgotinib, new CEO Dan O’Day has opted to shelve the rheumatoid arthritis program and all but a much smaller piece of the old development plan in the US. The big biotech said Tuesday afternoon that the FDA had erected a high barrier for this drug, which they couldn’t see a way around — or over.
As far as Gilead is concerned, the only commercially viable dose for this drug is 200 mg, and that’s not going to fly at the FDA, where they say regulators made clear in a Type A meeting that they would need to complete “substantial additional clinical studies.” Why? Regulatory concerns over testicular toxicity are running high for this drug, which had aimed to be the fourth JAK inhibitor on the US market.
Gilead will pay Galapagos €160 million to revise their collaboration on this drug, handing Galapagos rights and responsibility for the European marketing campaign, where it is now approved for sale. Galapagos is also taking over a slate of clinical trials where they still see potential in Europe, while the two will continue with a risky shot at IBD.
Earlier this year the FDA forced Gilead to take a knee on this drug, which once figured prominently in O’Day’s plans for revitalizing and diversifying the company’s pipeline, when they slapped down their application for rheumatoid arthritis. The Gilead execs “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis — which are all now scrapped.
Late-stage studies for ulcerative colitis and Crohn’s are being continued, with Gilead taking control of the Crohn’s program while Galapagos assumed responsibility for UC.
“While we believe that the clinical profile of Jyseleca could help many patients living with RA, we no longer see a viable path to U.S. approval in this indication,” said O’Day. “In this new context, Gilead and Galapagos believe it makes sense for Galapagos to drive commercialization in Europe. We are confident that through our strategic alliance with Galapagos, we will deliver many important new therapies for inflammatory diseases in the future.”
They will continue on with their safety studies, looking to address regulatory concerns about this therapy:
Week 26 data from the MANTA and MANTA-RAy studies, including primary and key secondary endpoints, will be available by mid-2021 and the parties expect to submit the data to regulatory authorities shortly thereafter. In order to complete their review of filgotinib in RA or other future indications, the FDA has requested up to Week 52 follow-up data for patients who show >50% decrease in semen parameters by Week 26 and do not recover in the ongoing MANTA and MANTA-RAy studies.
The big setback here is a key validation of AbbVie’s decision to walk away from filgo and turn their attention to Rinvoq, now approved and on the market, with analysts cheering on its potential in a huge market.
RBC’s Brian Abrahams joined analysts reading last rites over Gilead’s once promising clinical effort.
We believe the news is disappointing and marks an effective, albeit unsurprising, end to the high-opportunity promise the agent once had (and stands in particularly stark contrast to the $15B out-year sales guidance competitor ABBV just issued for their similar JAK1 inhibitor Rinvoq, + Skyrizi.
Tja, bij biotech beleggen is het vaak ook een kwestie van geluk hebben. Ik kan nou niet meteen zeggen dat Gala-beleggers onverantwoordelijke gokkers waren of zijn.