Gilead Sciences Inc. (GILD) said Tuesday that it will not pursue the U.S. Food and Drug Administration’s approval of Filgotinib for the potential treatment of rheumatoid arthritis in the U.S. following a meeting with the FDA.
The FDA in August declined to approve Gilead’s Filgotinib, proposed for the treatment of moderately to severely active rheumatoid arthritis. The regulatory agency had expressed concerns regarding the overall benefit/risk profile of the Filgotinib 200 mg dose.
Tuesday, Gilead concluded that the 200 mg dose is unlikely to receive an approval for rheumatoid arthritis in the U.S. without conducting substantial additional clinical studies.
Therefore, Gilead Sciences and Galapagos said they have agreed to amend their existing arrangement for the commercialization and development of Jyseleca or filgotinib.
As per the revised agreement, Galapagos will assume sole responsibility in Europe for filgotinib in rheumatoid arthritis, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications.
Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib.
The majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Gilead will retain commercial rights and remain marketing authorization holder for filgotinib outside of Europe, including in Japan where filgotinib has recently been approved, and is co-marketed with Eisai.
According to the companies, all commercial economics on filgotinib in Europe will transfer to Galapagos as of January 1, 2022, subject to payment of tiered royalties of 8 to 15 percent of net sales in Europe to Gilead, starting in 2024.
As per the amendments to commercialization and development of filgotinib, Gilead has agreed to irrevocably pay Galapagos 160 million euros, which will be split between a 110 million euros payment in 2021 and a 50 million euros payment in 2022.
In addition, Galapagos will no longer be eligible to receive any future milestone payments relating to filgotinib in Europe. Gilead expects to recognize the full amount of those payments in its R&D expenses in the fourth quarter of 2020.
Meanwhile, Gilead and Galapagos said they no longer believe it is feasible to continue the current clinical trials of filgotinib for psoriatic arthritis, ankylosing spondylitis and non-infectious uveitis. As a result, they will stop those trials.
However, they will continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease. Gilead will retain operational responsibility for the current trials in Crohn’s disease while Galapagos will assume operational responsibility for ongoing trials in Ulcerative Colitis.
Filgotinib is currently under review by the European Medicines Agency for the treatment of Ulcerative Colitis and is expected to be submitted to Japan in the first half of 2021.
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