Material aspect 1: Improving people’s lives
We strive to discover, develop, and eventually commercialize breakthrough medicines with novel modes of action, addressing disease areas of high unmet medical need. At the core of our mission is the improvement of the lives of patients suffering from severe diseases with medicines that offer novel treatment options.
We are pioneering for patients.
Our broad product pipeline comprises programs ranging from discovery to Phase 3 clinical trials in inflammation, fibrosis, osteoarthritis, and other indications. Together with our collaboration partner, Gilead, we are currently in the registration phase for filgotinib in RA. An NDA was submitted to the regulatory authorities in the U.S., Europe and Japan in 2019, and if approved, we expected to launch filgotinib in 2020, providing an important new treatment option for RA patients worldwide.
There is a real need for medicines with novel mechanisms of action that address the underlying cause of disease. There are many diseases for which there is no approved therapy today and many more diseases for which current therapies leave room for improvement in patient outcomes. New mechanism of action medicines offer the opportunity for alternative new clinical options for caregivers and patients. At the same time, they potentially decrease the burden for society, including by lowering healthcare costs.
Our highly flexible target and drug discovery platform has been applied across many therapeutic areas, and our deep pipeline today covers a range of diseases, with a focus on inflammation and fibrosis candidate drugs across all stages of development. Pending potential approval, we expect to make our first product available to patients with RA during the course of this year.
We continue to invest heavily in R&D and aim to initiate a Phase 3 trial every other year, while conducting at least three to four proof-of-concept trials, delivering at least three preclinical product candidates and at least six new validated targets annually. The impact of the ongoing COVID 19 pandemic on our R&D efforts at the time of publication of this report is described here.
Research and Development Expenses in 2019
+32% vs 2018
Based on our powerful drug discovery engine, we are building a deep, early pipeline of novel product candidates to ensure continued innovation, with potential benefits to patients, healthcare professionals and society.
We aim to select promising programs for internal development and commercialization and establish ourselves as a fully integrated biopharmaceutical company. With filgotinib and its potential for five launches in the next four years, we are well on track to deliver innovative medicines to patients. At the time of publication of this report, it was decided to pause the recruitment of ongoing filgotinib trials in connection with the coronavirus pandemic.
Accelerating innovation through collaborations
We have a number of collaborations with leading pharmaceutical companies to significantly enhance our R&D efforts and pursue innovation to the benefit of patients. We are very proud of the transformative R&D collaboration with Gilead that we entered into in 2019. This collaboration should enable us to substantially boost our pipeline of novel product candidates.
To further strengthen our fibrosis pipeline, in 2019, we entered into collaborations with Fibrocor and Evotec, to jointly work on innovative approaches to treat severe fibrotic diseases.
We evaluate new opportunities to add to our pipeline on a continuous basis in order to bring innovation to patients.
Access to our candidate medicines
In pursuit of the development and commercialization of novel medicines that have the potential to improve people’s lives, we encourage patients to participate in clinical trials whenever possible. These clinical trials are critical to gather the information (or data) needed to evaluate investigational products and seek their approval by health authorities, such as the FDA and the EMA.
Information about ongoing clinical trials for our investigational drugs is available on clinicaltrials.gov, a service of the U.S. National Institutes of Health that provides details on clinical trials conducted worldwide.
Next to the information on clinicaltrials.gov, there are several patient information portals where more information regarding Galapagos related Phase 3 studies can be found. For instance, as sponsor of the Phase 3 study with GLPG1690 in IPF, Galapagos has launched the ISABELA information portal.
In some rare cases, patients are unable to participate in clinical trials and have exhausted all available treatment options. In these cases, Galapagos has a policy in place to assess whether the investigational product can be offered to a patient outside of a clinical trial, through a program called “expanded access”. Expanded access is also often referred to as “compassionate use”. A full copy of our Expanded Access Policy can be found on our website.
Actions in 2019
- We delivered 6 new validated targets, compared to our goal of 6
- We nominated 3 new preclinical candidates, all with a novel mechanism of action, compared to our goal of 3
- We conducted 6 proof-of-concept trials, compared to our goal of 6
- We conducted >30 clinical trials involving >1,800 patients and healthy volunteers
- We submitted 1 product candidate (filgotinib) for regulatory review in the U.S., Europe and Japan, compared to our goal of 1
- We received 220 inquiries to our Medical Info portal, of which the large majority requested more information on inclusion in the ISABELA trials with GLPG1690
These successes brought us to 44 preclinical candidates since 2009, most of which have novel modes of action. Of these 22 have entered the clinic, 16 of which with novel modes of action.
- Continue to focus on innovation and further expand R&D capabilities to support the planned clinical trials in 2020
- Fully recruit the ISABELA trials with GLPG1690
- Report topline results of ongoing clinical trials in UC, IPF, SSc and OA
- Start a Phase 3 trial in AS with filgotinib together with Gilead
- Further broaden our R&D efforts beyond inflammation and fibrosis, including metabolic and kidney diseases with high unmet medical needs
- Invest in our target discovery capabilities, in order to broaden our pool targets, which in turn, should deliver more validated targets and proof-of-concepts on a yearly basis
- Continue to seek win-win collaborations to bolster the early-stage pipeline
- Pending potential approval, we expect to launch our first innovative product, filgotinib in RA in the U.S., Europe and Japan, with collaboration partner Gilead
- Continue the build-out of a European commercial organization to bring innovation to patients in need for breakthrough medicines
In order to increase our chances to find novel targets, we will expand our target workspace, and not only use the selected pool of 6,000 drugable genes, but the complete protein-coding genome of over 20,000 genes.
Current Financial Investments, cash and cash equivalents at end 2019
A strong balance sheet to ensure future growth