Galapagos Refocuses Pipeline and Rightsizes Operations
Galapagos NV (Euronext & NASDAQ: GLPG) announces its unaudited Q1 results and operational highlights, which are further detailed in the Q1 2021 report available on the Galapagos website.
“These last months, we completed a review of our portfolio and development plans with the goal to select a more risk-balanced pipeline. We decided to retain our focus on novel targets to address unmet medical needs in inflammation, fibrosis, and kidney diseases. We also remain fully committed to the launch of Jyseleca in Europe. Moving forward with confidence, we decided to:
- Refocus our clinical pipeline by critically examining its risk profile and breadth;
- Cut significant cost in the organization to support this re-sized pipeline development;
- Task our business development team to identify and execute on a transformative opportunity.
We believe that our strong cash position, expert teams, and solid scientific foundation position us well for future growth,” said Onno van de Stolpe, CEO of Galapagos.
Refocused pipeline
In the revision exercise, Galapagos set goals to focus and adjust the overall risk profile of its clinical pipeline. Consequently, they prioritised those assets with what they believe have enhanced chances of clinical success in the core therapeutic areas. As such, they announce:
- We are testing our lead Toledo program ‘3970, a SIK2/3 inhibitor, in five Proof of Concept studies in different indications, and pending the outcome of the studies, we plan to roll out our further development plans in the second half of the year;
- We selected an additional molecule from our Toledo program, SIK2/3 inhibitor '4876, as a candidate to accelerate from preclinical phase into clinical development;
- We aim to progress our TYK2 inhibitor ‘3667 into Phase 2b;
- We selected chitinase inhibitor ’4617 to progress to Phase 2 in IPF and decided to stop development of our other IPF molecule ’1205;
- We stopped further work on ‘4059 for metabolic disease, given that this is not a core therapeutic area;
- We discontinued our early research efforts in metabolic diseases and osteoarthritis; and
- We challenged and fine-tuned our stage-gating process to advance compounds.
Commercial progress
Galapagos remains well on track in launching filgotinib in Europe. In the first quarter, they successfully completed the transitions of commercial and medical teams from Gilead in Germany, the UK, Spain, and Italy. They believe everything is in place to complete the final transitions from Gilead to us by year-end. Q1 also saw progress on access and reimbursement for filgotinib in rheumatoid arthritis (RA). Gilead submitted the new drug application in Japan for the treatment of ulcerative colitis (UC). They are encouraged by the primary endpoint outcome with the MANTA/RAy semen parameter studies as they await the Committee for Medicinal Products for Human Use (CHMP) opinion in UC.
Bart Filius, President and COO, added, “In line with our review, we decided to discontinue or cancel certain studies and consequently identified opportunities to reduce operational costs, for a total potential savings of €150M on a full-year basis. Roughly half of these savings will be realised in 2021, resulting in a 2021 cash burni guidance of between €580 million and €620 million. We are working towards a right-sized, refocused version of Galapagos, setting us on a path towards success with our first commercial product, new R&D opportunities, substantial clinical news flow, and a lengthened cash runway for validation of our early pipeline assets.”
Source: Galapagos, HollandBIO
