Our mission is to develop and commercialize first-in-class medicines based on novel targets to improve patients’ lives.
Using human primary cells, we discover which proteins (“targets”) play a key role in disease pathways. We then identify and develop small molecules that are designed to inhibit these targets, and thereby positively influence the course of the disease. This approach is designed to address the root cause of the disease rather than just treating symptoms, and has produced a differentiated pipeline of molecules.
In 2021, we became the official Marketing Authorization Holder (MAH) for Jyseleca in the European Economic Area (EEA) and Great Britain, realizing our ambition to become a fully integrated, independent European biopharma. We are committed to pioneering for patients, with the aim to enrich our product pipeline to address unmet medical needs, both through internal R&D efforts and externally sourced opportunities.
The key elements of our strategy include:
- Maximize and capture the value of our target discovery platform and our differentiated pipeline based on novel modes of action
We continue to scale-up our target and drug discovery productivity, and as a result of the strategic revision exercise announced in 2021, we set goals to focus and adjust the overall risk profile of our clinical pipeline. We also continue to explore additional modalities of drug therapies, such as PROTACs1 and oligonucleotides, and are actively collaborating with external research partners to accelerate the innovation process.
- Grow our Jyseleca franchise in the European Union and Great Britain
We successfully completed the process of becoming MAH of Jyseleca following the amended agreement with Gilead announced in December 2020 (see Notes to the consolidated financial statements) and continue the roll-out of Jyseleca in RA and UC throughout the European Union and Great Britain. Patient enrollment for DIVERSITY Phase 3 in CD was completed in October 2021, and we anticipate topline results in the first half of 2023. Gilead remains responsible for sales outside of Europe and obtained approval for filgotinib in RA in Japan in 2020 where it is distributed by co-promotion partner Eisai. Gilead also submitted the application for approval of filgotinib in UC in Japan and anticipates a decision for approval in the first half of 2022.
- Deploy stringent cost discipline and operational excellence to maintain a strong balance sheet and execute to internal and externally sourced opportunities
Following a strategic review of operations in March 2021, we initiated a cost savings program of €150 million on a full year basis, where more than 50% of these targeted savings were realized in 2021. Meanwhile we diligently evaluate business development opportunities to strengthen our R&D engine and product pipeline.
- Build long-term value and accelerate our pipeline with our collaboration partner Gilead
In July 2019 we and Gilead entered into a strategic R&D collaboration, giving Gilead access to our innovative portfolio of compounds and our drug discovery platform, in return for a $3.95 billion upfront payment and a $1.5 billion equity investment (including the exercise of warrant A). Gilead is subject to a 10-year standstill, securing our long-term independence, with a lock-up of the full 25.49% of outstanding shares currently held by Gilead until 22 August 2024.
We strongly believe that the long-term collaboration with Gilead is mutually beneficial: we gain access to Gilead’s extensive experience in drug development and commercialization, and Gilead has access to our platform and pipeline, with option rights to our current and future programs outside Europe. If Gilead opts in, the program is co-developed, and Galapagos and Gilead share all costs.
Following the amendment in 2020 of the arrangement for the commercialization and development of filgotinib, we assumed sole responsibility for commercialization of Jyseleca in Europe and for the clinical development for the majority of the ongoing trials with filgotinib. For further details: see the Notes to the consolidated financial statements.
1 1Proteolysis Targeting Chimeras