Galapagos’ alliance strategy combines novel targets and candidate drugs discovered by Galapagos with patient expertise from Galapagos’ pharmceutical partners. Galapagos runs these programs until candidate drug, Phase 1 or Phase 2, at which point a partner has the option to license the program.
Galapagos and Gilead have been collaborating since 2015 on the development and, later the commercialization, of filgotinib in inflammatory diseases. The companies expanded their collaboration in 2019 with a 10-year transformative research and development agreement, through which Gilead gained access to Galapagos’ innovative portfolio of compounds in preclinical and clinical development, as well as our proven drug discovery platform.
Gilead received an exclusive product license and option rights to develop and commercialize all current and future programs in all countries outside Europe.
In 2020, Gilead and Galapagos amended the collaboration terms for the development and commercialization of filgotinib, now approved for rheumatoid arthritis and ulcerative colitis in the European Union and Great Britain, and for rheumatoid arthritis in Japan. The medicine is being advanced for other inflammatory diseases, to provide a broader commercialization role for Galapagos in Europe.
Under the amended agreement, Galapagos became the market authorization holder and is responsible for the commercialization of filgotinib in rheumatoid arthritis, ulcerative colitis, and if approved Crohn’s disease in Europe, providing the opportunity to build a commercial presence on an accelerated timeline.
Following the amended agreement with Gilead announced in October 2021, Galapagos will become the sole sponsor of the DIVERSITY trial of filgotinib in CD and the long-term extension study. The parties intend to complete the transfer no later than 30 June 2022. Under the terms of the agreement and upon completion of the transfer, Gilead will make a one-time payment of $15 million to Galapagos. From 1 April 2022, Galapagos will also be solely responsible for all development costs for DIVERSITY. In addition, if the EMA grants regulatory approval of filgotinib for the treatment of CD based on data from the DIVERSITY trial, then royalties payable by Galapagos to Gilead will be reduced by 30% across all filgotinib indications and will become 5.6 to 10.5% of net sales in Europe. These royalties are payable as of 2024. Gilead remains responsible for commercial activities outside of Europe..
However, we will remain eligible to receive tiered royalty percentages ranging from 20% to 30% on Gilead’s global net sales of filgotinib outside of Europe and future development and regulatory milestone-based payments of up to $295 million and sales-based milestone payments of up to $600 million.
We also establish relationships and work closely with academic organizations and universities to accelerate development and boost innovation in discovery, preclinical, and clinical development.