Given the impact of the COVID-19 pandemic, we sustain our efforts towards improving our understanding of people and business needs, and as such we have executed plans to accommodate for the current situation and minimize the impact to operations. We closely follow local governmental regulations and apply these as appropriate within our organization, guided and supported by our dedicated COVID-19 task force teams. All local and global task force teams meet regularly and make recommendations directly to the COO.
We report the following impacts:
We continue to follow the strict measures put in place to help prevent the spread of the COVID-19 virus and protect the health of our staff. We rolled out our global and site-specific business continuity plans and continue to take appropriate recommended precautions.
During lock-down periods, we arranged for essential tasks to be carried out within our facilities. Consequently, the majority of our Research staff continues to work from the office/labs, with periodic exceptions for local lockdowns during which no staff is allowed into the facilities. For those employees coming to the office, we have stringent cleaning and sanitation protocols in place, and we strictly respect social distancing policies at all times in order to minimize risk of exposure.
As the global pandemic has prevailed into 2021, we continue to sustain our efforts to maintain our strict measures and protocols to ensure safety and good health of our employees. Strictly following local governmental measures, we have started to welcome our employees back on site.
- Research portfolio
By prioritizing the most advanced projects very early on and increasing the flexibility of our dedicated research staff in the labs within projects, we sustain our research progress, and continue our early drug research and the implementation of new modalities for target or drug discovery.
So far, we note no material impact of the COVID-19 pandemic on our research portfolio.
- Development portfolio
We have a business continuity plan for our clinical development programs. We closely monitor each program in the context of the current global and local situation of the pandemic and the associated specific regulatory, institutional, and government guidance and policies related to COVID-19. Within the boundaries of these guidances and policies, and in consultation with our CROs and clinical trial sites, we applied various measures to minimize the impact of the COVID-19 pandemic on our clinical development programs, with the primary aim to ensure the safety of our trial participants and to preserve the data integrity and scientific validity of our trials. These measures continue to be implemented on a case-by-case basis, tailored to the specific study and geographic needs at any given time, with specific attention paid to vulnerable populations and the use of investigational medicines with immunosuppressive properties. The measures include, among others, increased, transparent communication to all stakeholders and the direct supply of investigational medicines to patients. For each clinical trial, we actively monitor and document the impact of COVID-19 where necessary and facilitate the interpretation and reporting of results.
Following the global increase of COVID-19 testing and vaccinations, we issued an internal guidance on the impact of testing and vaccinations on clinical trials.
- Filgotinib filing process UC
On 16 September 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the addition of UC as a new indication to the marketing authorization of Jyseleca. The Commission decision on this change to the marketing authorization is pending. In addition, the assessment of this new indication in Great Britain by the MHRA is ongoing as well.
As of publication of this Q3 report, our collaboration partner Gilead has not been informed by regulatory agencies of approval timeline delays related to the pandemic.
- Manufacturing and supply chain
To date, there has been no COVID-19 impact to the commercial supply of filgotinib. Gilead also confirmed that all sites involved in the manufacturing of filgotinib are established sites that currently manufacture other Gilead marketed products and are in good standing with the FDA and are GMP certified. Under the revised agreement with Gilead for filgotinib in Europe, Galapagos plans to become the marketing authorization holder of filgotinib in Europe by year-end 2021, and then become responsible for manufacturing. We plan to work with the same manufacturing sites as Gilead except for secondary packaging and labelling for which a new vendor has been selected.
- Commercial organization
The form of outreach of our commercial teams to physicians and hospitals was impacted by the COVID-19 pandemic and consequent travel restrictions, and thus became partially virtual. The teams invested in digital channels as part of the overall commercial build strategy, and these channels are being utilized during our ongoing commercial launch. Thus far we note no material impact on our commercial operations due to travel restrictions, nor has there been an impact of COVID-19 on our ability to engage in market access discussions. Nevertheless, healthcare systems are under pressure across Europe, increasing the volatility in reimbursement procedures and potentially reducing the number of new therapy options initiated by healthcare providers.