Gilead, Galapagos in new commercialization pact for filgotinib

 

• Following a Type A meeting with FDA discussing complete response letter related to Jyseleca's (filgotinib) marketing application for Rheumatoid Arthritis (RA), Gilead Sciences (NASDAQ:GILD) and Galapagos (NASDAQ:GLPG) have agreed to amend their existing arrangement for the commercialization and development of the drug candidate, with Gilead dropping pursuit of FDA approval of the treatment for rheumatoid arthritis (RA).
• Move follows that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without substantial additional clinical studies.
• Galapagos will assume sole responsibility in Europe for Jyseleca in RA and ulcerative colitis (UC), plus future indications, with Gilead to receive tiered royalties of 8%-15% on net European sales starting in 2024.
• Recently filgotinib trials in psoriatic arthritis, ankylosing spondylitis, and non-infectious uveitis following receipt of the CRL were paused and, the companies no longer believe it is feasible to continue development for filgotinib in these indications. As a result, these trials will be stopped over the coming months.
• Both parties will continue filgotinib study in Inflammatory Bowel Disease (IBD). Filgotinib is currently under review by the European Medicines Agency for UC and is expected to be submitted to the Japanese regulatory authority in 1H of 2021. Further clarity on the potential U.S. filing in IBD, after consultation with FDA.
• Gilead will pay Galapagos €160M to support on-going development, and Galapagos will no longer be eligible to receive any future milestone payments relating to filgotinib in Europe.
• https://seekingalpha.com/news/3644680-gilead-galapagos-inks-new-commercialization-pact-for-filgotinib