In the second half of 2020, we were expecting regulatory decisions for our first product candidate, filgotinib for rheumatoid arthritis (RA), in the US, Europe and Japan.
Today we received very disappointing and unexpected news: our collaboration partner and US market authorization holder, Gilead, received a Complete Response Letter, or CRL, from the FDA, indicating that at this time, the agency considers the data package available insufficient for approval of filgotinib in RA. Specifically, the FDA has requested to see the completed MANTA and MANTA-RAy studies, designed to assess whether filgotinib has an impact on sperm parameters (as a consequence of preclinical effects observed in animal studies with high doses of filgotinib). These studies are fully recruited, with topline results anticipated in the first half of 2021. The FDA has also expressed concerns regarding the overall benefit/risk profile of the filgotinib 200mg dose.
Let me start by saying that we are very disappointed in the outcome, and this is an important set-back. However, Gilead and Galapagos continue to believe in the risk/benefit profile of filgotinib, and in its potential to provide an effective treatment for patients with RA and other autoimmune diseases, where a significant unmet need remains.
Gilead and we are keen to evaluate the points raised by the FDA, and we are convinced that Gilead has the know-how and experience to determine appropriate next steps, and guide us through this process. With Gilead, we intend to inform you on next steps when we can.
While we are working on addressing the FDA issues, in Europe the regulatory process is progressing well: the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for filgotinib, recommending the approval of both the 100 and 200 mg dose in moderate to severe RA patients who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs, both in combination with methotrexate and as monotherapy.
We now expect a European regulatory decision in the third quarter, and, pending approval, our commercial teams stand ready to launch filgotinib in the countries where we commercialize, starting later this year. It’s very exciting to take this final step in our transformation to a fully integrated biotech, and I want to express my gratitude and pride for all of them who are working tirelessly to bring filgotinib to patients.
As proud as we are of filgotinib, let’s not forget that there is so much more to the Galapagos story: driven by our unique drug discovery platform, we boast an exceptionally broad and deep pipeline of early to late stage programs. While the focus remains on our key franchises in inflammation and fibrosis, we have promising programs in additional indications with high unmet medical needs.
This exciting platform and rich pipeline is precisely what attracted Gilead to engage in a long-term collaboration with us last year, and both companies remain fully committed to the partnership.
Thanks to our very strong balance sheet, ending June 2020 with cash & current financial investments of €5.7 billion, we are well positioned to further ramp up our internal pipeline and seize smart opportunities. We strongly believe that we have the science, the people, and the funding to continue to discover and develop molecules with novel modes of action, in our unwavering ambition to bring much needed medicines to patients worldwide.
On behalf of our management, I want to thank all Galapagos employees, stakeholders and investors for your support. We faced challenges before in our 20 year history, and we came out stronger, time and again. It is in our DNA to take this in stride, to straighten our shoulders and look to the future of Galapagos, which I am convinced remains an exciting one.
Onno van de Stolpe