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
There is a real need for medicines with novel mechanisms of action that address the underlying cause of a 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, 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. Following the approval of our first product, filgotinib in RA, we have launched filgotinib in a number of European territories, and expect to further accelerate the commercial roll-out in Europe in the course of 2021. We hope to receive approval from the European authorities for a second indication, UC, later this year as well, and look forward to bringing filgotinib to patients living with this debilitating disease throughout Europe.
We continue to invest heavily in R&D and aim to initiate a Phase 3 trial every other year, to conduct at least three Proof of Concept trials, and deliver 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 2020
+25% vs 2019
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 to establish ourselves further as a fully integrated biopharmaceutical company. With filgotinib now launched and with a deep pipeline of early to late stage programs, we continue to focus on our mission to deliver innovative medicines to patients.
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 signed in 2019. This collaboration should enable us to substantially boost our pipeline of novel product candidates.
To strengthen our inflammation pipeline further, in 2020, we entered into collaborations with Ryvu and Scipher Medicine to discover and develop novel target drugs in inflammation. Within our fibrosis pipeline, we entered into a collaboration with OncoArendi, to work jointly 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 research publications
Open access publishing will best serve our aim to make our research freely available to the research community and other stakeholders. We aim to contribute to society through discovery of breakthrough therapies for diseases with large unmet medical need. By opening up access, we make our scientific research publications publicly available.
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 example, our partner Gilead launched a study information portal regarding the Phase 3 studies with filgotinib in Crohn’s disease (DIVERSITY).
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 2020
- We delivered 5 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 10 Proof of Concept trials, compared to our goal of 11
- We submitted 1 product candidate (filgotinib) for regulatory review in an additional indication in Europe, compared to our goal of 1
- We received 1 regulatory approval for our product candidate (filgotinib) in Europe and Japan
- In June 2020, we set up a new Galapagos Medical Information service, and we received 272 inquiries
These efforts brought us to 47 preclinical candidates since 2009, most of which have novel modes of action. Of these, 24 have entered the clinic, 18 of which are expected to have novel modes of action.
- Report topline results of ongoing clinical trials, including our Proof of Concept trials from our Toledo program
- Launch an information portal on our clinical trials for patients and physicians
- Invest in our target discovery capabilities, in order to broaden our pool of 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 in UC, an additional indication for our first innovative product, filgotinib in Europe
- Further strengthen our European commercial organization to bring innovation to patients in need of breakthrough medicines
In order to increase our chances of finding novel targets, we aim to 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 2020
A strong balance sheet to ensure future growth