Galapagos NV (Galapagos) is a biotechnology company with operations in Europe and the U.S. dedicated to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life.
Focusing on high unmet medical needs, the company synergizes compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform...
Galapagos NV (Galapagos) is a biotechnology company with operations in Europe and the U.S. dedicated to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life.
Focusing on high unmet medical needs, the company synergizes compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, the company is committed to challenging the status quo and delivering results for the company’s patients, employees, and shareholders.
The company’s clinical pipeline includes: 1) GLPG5101, a CD19 CAR-T product candidate decentralized manufactured, in Phase 1/2 in rrNHL; 2) GLPG5301, a BCMA CAR-T product candidate decentralized manufactured, in Phase 1 in rrMM, and 3) GLPG3667, a TYK2 inhibitor in Phase 2 clinical trial in DM and in SLE. In both the company’s oncology and immunology portfolios, the company has multiple product candidates in early research stages.
Platforms
Cell Therapies and Small Molecules
Revolutionizing cell therapy manufacturing for faster and broader patient access
At Galapagos, the company’s scientists are dedicated to addressing the urgent needs of cancer patients who cannot wait for treatment.
To accelerate and expand access to cell therapies, the company is pioneering a decentralized manufacturing approach that brings production closer to patients. The company’s cell therapy manufacturing platform has the potential to dramatically reduce vein-to-vein time - the time between leukapheresis to infusion - from months or weeks to just seven days, thereby enabling the rapid delivery of potential life-saving treatments.
Beyond speed, a fundamental goal of cell therapy manufacturing is to deliver fit T-cells with strong self-renewal capacity and long-term functionality1. In practice, T-cells often lose self-renewal capacity during culture and transduction, where they differentiate and become exhausted2.
To meet these objectives, the company is implementing a globally scalable, innovative, and decentralized cell therapy manufacturing platform. This platform is designed to deliver fresh, fit, stem-like early memory T-cells with a median vein-to-vein time of seven days, while also enhancing physician oversight and improving the patient experience.
Encouragingly, the company’s platform has shown higher proportions of early T-cell phenotypes—including naïve/stem cell memory (TN/SCM) and central memory (TCM) cells—in the final therapeutic product for the company’s first-generation CD19 Car-T product candidates, GLPG5101 and GLPG5201, compared to the starting material available after initial leukapheresis. These findings reinforce the potential of the company’s approach to redefine cell therapy manufacturing and improve patient outcomes3.
Galapagos’ innovative and differentiating decentralized cell therapy platform consists of an end-to-end xCellit workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon) and a proprietary quality control testing and release strategy.
The company is preparing to initiate pivotal development of the company’s lead CD19 CAR-T candidate, GLPG5101, in 2026, with the goal of obtaining the first approval in 2028, using the company’s decentralized manufacturing approach. At the same time, the company is committed to leveraging its platform as broadly as possible with new modes-of-action and indications to further enhance patient care. This includes advancing next-generation cell therapy programs, such as armored, multi-targeting constructs in both hematological and solid tumors, to maximize impact.
To achieve these goals, and supported by the company’s strong collaborations with Lonza (for the Cocoon platform) and Thermo Fisher Scientific (for the development of an ultra-rapid PCR sterility test together with miDiagnostics), the company is scaling up manufacturing capacity at the company’s existing decentralized manufacturing units (DMUs) in the U.S., including Landmark Bio (Boston area), Excellos (San Diego area), and Catalent (New Jersey, New York, and surrounding areas), as well as at multiple DMUs in key European markets. Additional DMUs will be integrated into Galapagos’ network to ensure sufficient capacity to support future pivotal studies in key regions.
In January 2025, the company entered into a strategic collaboration with Catalent, a global contract development and manufacturing organization (CDMO) Catalent’s commercial cell therapy manufacturing facility in Princeton, New Jersey will support manufacturing for the company’s upcoming clinical studies in New Jersey, New York and surrounding areas.
In February 2025, the company entered into a strategic collaboration with NecstGen, a leading CDMO dedicated to cell and gene therapies located at the Leiden Bio Science Park, the Netherlands, to support decentralized manufacturing of the company’s candidate cell therapy products.
Innovation engine to develop next-generation cell therapies
With the 2022 acquisition of U.S.-based AboundBio, the company has significantly expanded the company’s capabilities in next-generation cell therapy discovery and development. The company’s innovation engine is built on the ability to generate vast and diverse human antibody libraries in multiple formats, including antigen-binding fragments (Fab), single-chain variable fragments (scFv), and unique variable heavy (VH) domains. These libraries enable the rapid discovery of high-affinity binders, within days to weeks, that can be optimized for development and adapted for various applications, such as multi-targeting CARs.
The company’s next-generation cell therapy pipeline provides a strong foundation for sustainable value-creation. It comprises multi-targeting, armored cell therapy constructs designed to improve potency, prevent resistance, and improve persistence of CAR-Ts in hematological and solid tumors.
The company is preparing to initiate clinical development of its first armored, bi-specific CAR-T candidate in 2025, and the company’s intention is to expand its clinical pipeline with at least one new program per year starting in 2026.
By leveraging proprietary methodologies, the company enhances binder diversity, affinity, and specificity, increasing the potential for next-generation, multi-targeting, armored cell therapies. These innovations aim to address key limitations of existing treatments by improving potency, preventing resistance, and enhancing therapy persistence, even in cases of relapse.
By combining the company’s existing clinical pipeline with the company’s next-generation portfolio and innovative manufacturing approach, Galapagos is committed to reshaping the future of oncology care and making a meaningful impact on patients' lives.
Small Molecule Platform
The company has built extensive expertise in small molecule research and development. The company’s in-house capabilities include chemical library development, high throughput screening, pharmacology, and preclinical development with the goal of accelerating the time from target identification to first-in-human clinical development.
On January 8, 2025, the company announced a plan to separate into two publicly traded entities. As part of the planned strategic reorganization, the company is seeking partners to take over the company’s small molecule portfolio.
Lead Programs
Oncology
1.GLPG5101: CD19 CAR-T to expand to eight aggressive B-cell malignancies, broadening patient reach and impact
GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are being evaluated in the ATALANTA-1 Phase 1/2 study in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL).
The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101.
The dose levels that were evaluated in Phase 1 are 50x106 (DL1), 110x106 (DL2), and 250x106 (DL3) CAR+ viable T-cells.
The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response Rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months.
In December 2024, the company presented new data from the ongoing ATALANTA-1 Phase 1/2 study at the 2024 Annual Meeting of the American Society of Hematology (ASH) Meeting, which included updated data on patients with mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) / follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL).
GLPG5101 showed an encouraging safety profile, with the majority of Grade = 3 treatment emergent adverse events being hematological. One case of CRS Grade 3 was observed in Phase 1 and one case of ICANS Grade 3 was observed in Phase 2.
96% of patients (47 of 49) received an infusion with fresh, fit, stem-like early memory (naïve/stem cell memory and central memory) CD19 CAR T-cell therapy, with 91.5% (43 of 47) achieving a vein-to-vein time of seven days, thereby avoiding cryopreservation, and eliminating the need for bridging therapy.
Strong and consistent in vivo CAR-T expansion levels and products consisting of stem-like, early memory phenotype T- cells were observed in all doses tested. This early phenotype reflects the differentiation status of the cells, which is associated with enhanced functionality and persistence of CAR-T cells, which could potentially be an early predictor of durable responses after infusion.
Beyond MCL, MZL/FL and DLBCL, the ATALANTA-1 study also includes high-risk first line DLBCL, Burkitt lymphoma (BL), and primary CNS lymphoma (PCNSL). Patient recruitment is ongoing in Europe. With the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application clearance secured, leading cancer centers in Boston have been activated, and patient screening has begun. Boston-based Landmark Bio is operational and serves as the decentralized manufacturing unit (DMU) for ATALANTA-1.
Building on these encouraging data and in line with its goal to streamline the business, the company is focusing its resources on accelerating GLPG5101 as the company’s flagship CD19 CAR-T program, and pending the advancement of GLPG5101 in additional indications, are deprioritizing activities for GLPG5201, the company’s second CD19 CAR-T candidate. With the addition of double-refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT) of CLL, both indications with significant unmet needs, GLPG5101 would be developed across eight aggressive B-cell malignancies, further unlocking its broad potential to address significant unmet medical needs.
The company intends to present additional new data at a medical meeting in 2025.
The fitness of the final product was evaluated by measuring the level of CAR T-cell expansion. The company observed robust CAR T-cell expansion in treated patients across all dose levels. At the cut-off date of April 24, 2024, 15 out of 18 evaluable patients (83%) had detectable CAR T-cells at 6 months post-infusion: 75% in Phase 1 and 100% in Phase 2. Persisting CAR T-cells could be detected up to 21 months post-infusion. These findings support persistence of GLPG5101, which could be an early predictor of durable responses.
These initial results reinforce the potential of Galapagos’ innovative, decentralized cell therapy manufacturing platform to deliver fresh, stem-like, early memory CD19 CAR T-cell therapy, with a median vein-to-vein time of seven days.
Building on these encouraging data and in line with the company’s goal to streamline the business as announced on January 8, 2025 and February 12, 2025, the company is focusing its resources on accelerating GLPG5101 as the company’s flagship CD19 CAR-T program, and pending the advancement of GLPG5101 in additional indications, are deprioritizing activities for GLPG5201, the company’s second CD19 CAR-T candidate. With the addition of double-refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT) of CLL, both indications with significant unmet needs, GLPG5101 would be developed across eight aggressive B-cell malignancies, further unlocking its broad potential to address significant unmet medical needs.
2.GLPG5201: CD19 CAR-T in relapsed/refractory chronic lymphocytic leukemia and Richter transformation
GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5201 were evaluated in the EUPLAGIA-1 Phase 1/2, open-label, multicenter study in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), small cell lymphocytic lymphoma (R/R SLL), and Richter transformation (RT).
Patients with CD19+ R/R CLL or R/R SLL with >2 lines of therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1) and 100x106 (DL2) CAR+ viable T cells.
The primary objective of the Phase 2 part of the study is to assess the ORR and the secondary objectives including the analysis of the CRR, duration of response, progression free survival, overall survival, safety pharmacokinetic profile, and feasibility of decentralized manufacturing.
In December 2024, the company presented initial encouraging safety and efficacy encore data from the EUPLAGIA-1 Phase 1/2 study during a poster session at the 2024 Annual Meeting of the American Society of Hematology (ASH) Meeting.
As of the data cut-off on February 21, 2024, patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and, 15 patients (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)) were enrolled, all of whom were diagnosed with R/R CLL, and 9 with additional RT. All 15 Phase 1 batches were manufactured using Galapagos’ decentralized platform and infused as a single fresh, fit product within a median vein-to-vein time of seven days, with 80% of patients receiving the product in seven days. Safety and efficacy results were available for 15 patients.
The fitness of the final product was evaluated by measuring the level of CAR T-cell expansion. The company observed robust CAR T-cell expansion in treated patients across both dose levels.
Building on the encouraging ATALANTA-1 data and in line with the company’s goal to streamline the business as announced on January 8, 2025 and February 12, 2025, the company is focusing its resources on accelerating GLPG5101 as the company’s flagship CD19 CAR-T program, and pending the advancement of GLPG5101 in additional indications, are deprioritizing activities for GLPG5201, the company’s second CD19 CAR-T candidate. With the addition of double-refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT) of CLL, both indications with significant unmet needs, GLPG5101 would be developed across eight aggressive B-cell malignancies, further unlocking its broad potential to address significant unmet medical needs.
3.GLPG5301: BCMA CAR-T in relapsed and refractory multiple myeloma
GLPG5301 is a second-generation/4-1BB B-cell maturation antigen (BCMA)-directed CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5301 are being evaluated in the PAPILIO-1 Phase 1/2, open-label, multicenter study in patients with relapsed/refractory multiple myeloma (R/R MM) after =2 prior lines of therapy.
The primary objective of the Phase 1 part of the PAPILIO-1 study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the study is to evaluate the efficacy of GLPG5301, as measured by the Objective Response Rate (ORR). Secondary objectives for both Phase 1 and Phase 2 include further assessment of the safety of GLPG5301, additional efficacy endpoints, including assessment of Minimal Residual Disease (MRD), as well as the feasibility of decentralized manufactured GLPG5301 in R/R MM patients. Each enrolled patient will be followed for 24 months. During Phase 1, up to 2 dose levels will be evaluated and at least 12 patients will be enrolled to establish the recommended Phase 2 dose. Approximately 30 additional patients will be enrolled in the Phase 2 part of the study to further evaluate the safety and efficacy of GLPG5301.
The Phase 1 part of the PAPILIO-1 Phase 1/2 study is recruiting patients. In 2024, the company submitted a protocol amendment to the European regulatory authorities following one observed case of Parkinsonism and resumed enrolment in the Phase 1 part of the PAPILIO-1 Phase 1/2. Upon completion of Phase 1 and analysis of the data, the company will evaluate the most appropriate development strategy and next steps.
The company intends to present Phase 1 data at a future medical conference.
4.Uza-cel: MAGE-A4 directed TCR T-cell therapy candidate, co-expressing CD8a
In May 2024, Galapagos signed a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy (uza-cel) targeting MAGE-A4, and co-expressing the CD8a co-receptor, for head and neck cancer, and potential future solid tumor indications, using Galapagos’ cell therapy manufacturing platform.
In December 2024, the company and Adaptimmune presented strong preclinical proof-of-concept data at the annual ASH meeting for uza-cel. The data demonstrated that Galapagos’ decentralized cell therapy manufacturing platform can produce uza-cel with features that may result in improved efficacy and durability of response in the clinic compared with the existing manufacturing procedure (see graphs below).
Preparations are ongoing with the goal to start clinical development in 2026.
5.Next-generation early-stage cell therapy pipeline
The company’s proprietary early-stage pipeline provides a strong foundation for sustainable value-creation.
It comprises multi-targeting, armored cell therapy constructs designed to improve potency, prevent resistance, and improve persistence of CAR-Ts in high-unmet need hematological and solid tumors, including B-cell malignancies, SCLC, and neuro-endocrine and platinum-resistant ovarian cancer.
The company plans to initiate clinical development of a novel CAR-T candidate in 2025 and to expand the company’s clinical pipeline of next-generation programs with the addition of at least one clinical asset from 2026 onwards.
Immunology
1.Jyseleca Franchise
On January 31, 2024, the company announced the successful completion of the transaction to transfer the company’s entire Jyseleca (filgotinib) business to Alfasigma S.p.A. (Alfasigma), including the European and UK Marketing Authorizations, and the commercial, medical affairs and development activities for Jyseleca. In connection with the completion of the transaction, approximately 400 Galapagos positions in 14 European countries have been transferred to Alfasigma to support business continuity and ongoing patient access.
In 2020, filgotinib obtained regulatory approval in Europe, Great Britain, and Japan for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Filgotinib obtained regulatory approval for the treatment of adults with moderate-to-severe ulcerative colitis (UC) in the European Union in 2021, and in Great Britain and Japan in January and March 2022, respectively.
2.TYK2 program: GLPG3667
The company is advancing its TYK2 inhibitor, GLPG3667, in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM). Patient randomization of the SLE study was completed in February 2025, ahead of schedule. Topline results for the entire GLPG3667 program are anticipated in the first half of 2026.
Following the planned strategic reorganization as announced early this year, the company is seeking potential partners to take over the company’s small molecule assets, including GLPG3667 for SLE, DM, and other potential auto-immune indications.
GLPG3667 is an investigational reversible and selective TYK2 kinase domain inhibitor that was discovered by the company and evaluated in a Phase 1 healthy volunteer study in 2020. The Phase 1 study was a randomized, double-blind, placebo-controlled dose escalation study evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of GLPG3667 for 13 days.
Blood was drawn at multiple time points on Day 1 and on Day 10 and stimulated ex vivo with several cytokines, including IFNa, to analyze the level of inhibition of inflammation, including the effect on phosphorylated signal transducer and activator of transcription (pSTAT) signaling, as well as hematological parameters, lipids, and creatine phosphokinase (CPK).
Following these results, the company initiated a randomized, placebo-controlled, double-blind Phase 1b study in 31 patients with moderate to severe plaque psoriasis. Patients were randomized in a 1:1:1 ratio to a daily oral dose of GLPG3667 (low dose or high dose) or placebo, for a total of 4 weeks.
In July 2021, the company announced positive topline results demonstrating that GLPG3667 was generally well tolerated with a positive response signal at Week 4:
At Week 4, 4 out of 10 patients in the high dose group had a Psoriasis Area and Severity Index (PASI)50 response, defined as at least a 50% improvement in PASI from baseline, compared to one out of 10 subjects on placebo. There were no subjects with a PASI 50 response on the low dose of GLPG3667. The 4 responders in the high dose group of GLPG3667 achieved a 52%, 65%, 74% and 81% improvement respectively in their PASI scores from baseline, while the subject randomized to placebo improved by 52%. Positive efficacy signals were also observed with the high dose for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at Week 4.
One subject in the low dose group interrupted participation in the study for one day due to exacerbation of psoriasis. The majority of treatment related adverse events (AEs) were mild in nature and transient. There were no deaths or serious adverse events (SAEs) in this 4-week study.
2.1 GLPG3667 in systemic lupus erythematosus (SLE)
In August 2023, the company announced that the first patient was enrolled in GALACELA, the Phase 3-enabling study with GLPG3667 in patients with SLE.
GALACELA Phase 2 study design with GLPG3667 in SLE
GALACELA is a Phase 3- enabling randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of GLPG3667 in adults with active SLE. A once-daily oral administration of GLPG3667 or placebo will be investigated in approximately 140 adult patients with SLE for 32 weeks.
The primary endpoint is the proportion of patients who achieve the SLE responder index (SRI)-4 response at Week 32. The secondary efficacy endpoints are the proportion of patients who achieve the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 32, proportion of patients with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 16, proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and change from baseline in the 28-joint count for tender, swollen, and tender and swollen (active) joints at Week 32.
In February 2025, patient randomization for the GALACELA study was completed, ahead of schedule.
2.2 GLPG3667 in dermatomyositis (DM)
In April 2023, the company announced that the first patient was dosed in GALARISSO, the Phase 2 study with GLPG3667 in DM patients.
GALARISSO is a Phase 3-enabling randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667. A daily oral administration of GLPG3667 150mg or placebo will be investigated in approximately 62 adult patients with DM over 24 weeks. The primary endpoint is the proportion of patients with at least minimal improvement in the signs and symptoms of DM at Week 24 according to the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) criteria7.
Topline results for the entire GLPG3667 program in both SLE and DM are expected in the first half of 2026.
Intellectual Property
As of March 1, 2025, patent rights held by Galapagos NV relating to the company’s product candidates include the following:
GLPG5101 product candidate: GLPG5101 is being developed in the company’s decentralized manufacturing model for the treatment of certain malignancies, such as relapsed/refractory NHL. For this model, the company has obtained an exclusive worldwide license from Lonza AG to use the Cocoon for the commercial decentralized manufacture of cell therapy for the treatment of hematological malignancies.
GLPG5301 product candidate: GLPG5301 is being developed in the company’s decentralized manufacturing model for the treatment of certain malignancies, such as relapsed/refractory MM. For this model, the company has obtained an exclusive worldwide license from Lonza AG to use the Cocoon for the commercial manufacture of cell therapy for the treatment of hematological malignancies. The company also has an exclusive license and supply agreement on the materials to produce and use the company’s GLPG5301 product candidate.
GLPG3667 product candidate: The company has a granted U.S. patent application, and one pending U.S. patent application. The company has one patent granted via the European Patent Office (EPO) and one pending patent application at the EPO, as well as further granted patents inter alia in Japan and Australia. In addition, the company has counterpart foreign patent applications that are pending in Canada, China and other foreign countries claiming GLPG3667 compositions of matter and methods of treatment using GLPG3667. Patents, if any, that issue based on this pending patent application are estimated to expire in 2038, not including any potential extensions for the marketed product that may be available via supplementary protection certificates or patent term extensions. The company also has one U.S. pending patent application, as well as other foreign jurisdictions claiming dosage regimen, and any patent, if granted is estimated to expire in 2042. Finally, the company has four pending applications under the Patent Cooperation Treaty (PCT) disclosing solid forms, metabolites, and/or methods for treating inflammatory disorders using GLPG3667; any patents, if granted, based on these patent applications are estimated to expire in 2043.
Collaborations
The company has entered into multiple collaboration agreements with pharmaceutical partners. The company expects to continue to collaborate selectively with pharmaceutical and biotechnology companies to leverage the company’s discovery platform and accelerate product candidate development. The company’s alliances include the alliances with Gilead and the restructured alliance with AbbVie.
On July 20, 2022, the company’s exclusive Collaboration and License agreement with Molecure (formerly known as Oncoarendi Therapeutics) terminated.
On January 8, 2025, the company announced an intended separation into two entities, in which the company would spin out a newly to be formed company (to be named at a later date, hereinafter ‘SpinCo’), which would focus on building a pipeline of innovative medicines through transformational transactions. The company would continue to advance its global cell therapy leadership in addressing high unmet medical needs in oncology. In the framework of the separation, the company and Gilead have agreed to amend the existing arrangements between the company, as further described below.
Option, License and Collaboration Agreement with Gilead
In July 2019, the company entered into a 10-year global research and development collaboration with Gilead. The company closed the transaction on August 23, 2019.
Under the terms of the option, license and collaboration agreement, Gilead received (a) an exclusive research and development license for Gilead to conduct certain contributions contemplated by the license and collaboration agreement and (b) an option to acquire exclusive commercial licenses in all countries outside of Europe to all current and future clinical programs of Galapagos (other than filgotinib, which is already subject to an existing collaboration between the parties, and certain other programs already committed to other companies) being developed during the 10-year initial option term of the collaboration (subject to extension in certain circumstances). Under the option, license and collaboration agreement, the company would continue to lead and fund all discovery and development of the company’s programs until the end of the relevant Phase 2 clinical trials. After the completion of the relevant Phase 2 clinical study for each program, Gilead would have the option to acquire an exclusive commercial license to that program in all countries outside of Europe. If an option were exercised, Gilead and the company would co-develop the compound and share costs equally.
In addition, under the option, license and collaboration agreement, Gilead was deemed to have exercised its option to a particular candidate, ziritaxestat, on which the company has since agreed to discontinue further work.
For GLPG1972, a drug candidate resulting from the company’s osteoarthritis collaboration with Servier that was subject to separate option and milestone payments under the option, license and collaboration Agreement, Gilead declined to exercise its option under the agreement in November 2020.
Exclusive collaboration agreement with Gilead for filgotinib
In December 2015, the company entered into a global collaboration agreement with Gilead to develop and commercialize filgotinib for the treatment of inflammatory indications. In connection with entering into the option, license and collaboration agreement with Gilead, in August 2019 the company amended and restated this agreement to increase the company’s involvement in filgotinib’s global strategy and participate more broadly in the commercialization of filgotinib in Europe.
In December 2020, the company agreed to amend this agreement again, as a result of which the company has assumed all development, manufacturing, commercialization and certain other rights for filgotinib in Europe through a transition largely completed at the end of 2021 and fully completed by the end of 2022. Gilead retains commercial rights and remains marketing authorization holder for filgotinib outside of Europe, including in Japan.
Under the terms of the collaboration, Gilead is primarily responsible for seeking regulatory approval of filgotinib in countries outside of Europe. Pursuant to the amended arrangements agreed in December 2020, the company is responsible for commercializing filgotinib in Europe.
Drug discovery collaboration transaction with NovAliX
Effective July 1, 2023, the company entered into an integrated drug discovery collaboration with NovAliX, a drug-discovery focused Contract Research Organization based in Strasbourg, France. Under the terms of the agreement, the company’s drug discovery and research activities conducted in Romainville, France, and the company’s employees in Romainville, which were exclusively dedicated to the operation of these activities, were transferred to NovAliX who will assume all ongoing research and discovery activities in Romainville, and this for no consideration. In return, the company is committed to utilizing the research capabilities and expertise of NovAliX through a five year-collaboration and within the context of the company’s R&D portfolio, during which the company is committed to purchase for a total of €73.8 million services from NovAliX.
Government Regulation
Any products which the company receive FDA approval for are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, tracking and tracing requirements, complying with certain electronic records and signature requirements, and complying with FDA promotion and advertising requirements.
History
Galapagos NV was founded in 1999. The company was incorporated in Belgium in 1999.
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