Filgotinib

Filgotinib: selective JAK1 inhibitor with a potential best-in-class product profile

We believe that filgotinib is a promising candidate for the treatment of RA, CD and potentially other inflammatory diseases. We have an exclusive collaboration agreement with Gilead to develop and commercialize filgotinib in multiple diseases. Under the terms of the collaboration, Gilead is primarily responsible for development and seeking regulatory approval of the licensed product. We assist Gilead with certain development activities. Gilead initiated Phase 3 clinical programs in RA and CD and a Phase 2b/3 program in UC in 2016, and we and Gilead initiated multiple Phase 2 trials with filgotinib in additional indications in 2017:

Building the filgotinib franchise

Building the filgotinib franchise (graphic)

Markets for inflammation drugs are considerable and growing. We estimate that the inflammation market could grow to ~$65 billion by 2027, driven by new drugs filling the current unmet need for oral, monotherapy treatments with a rapid response, and higher efficacy maintained over time. RA remains the largest market at approximately $30 billion in these forecasts, with the other main markets growing considerably as well:

Inflammation market in ~2027, $B

Estimated 2027 inflammation market size (pie chart)

Based on the Phase 2 data observed with filgotinib in RA and CD thus far, we believe that filgotinib has the potential to improve treatment standards substantially in RA and inflammatory bowel diseases. Compared with biologic agents, filgotinib is orally administered, with a rapid onset, sustained response, and potential for monotherapy. ACR scores with filgotinib in Phase 2 trials in RA patients are encouraging, and CDAI remission and SES-CD50 scores are similarly promising with filgotinib in a Phase 2 trial in CD patients who are naïve to TNF therapy. Filgotinib is highly selective for JAK1, resulting in favorable tolerability so far, including low rates of infection.