Galapagos ($GLPG) has started the countdown to the day on which AbbVie ($ABBV) must decide whether to hand over $200 million (€181 million) in exchange for its Phase III-ready rheumatoid arthritis drug. The timer started ticking down this week when Galapagos handed over the final Phase II data set.
|Galapagos CEO Onno van de Stolpe|
Mechelen, Belgium-based Galapagos has now given AbbVie 24-week data from both Phase IIb trials of its selective JAK1 inhibitor, filgotinib. The release of data from the first of the studies sent shares in Galapagos to new highs in Amsterdam. And the enthusiasm has survived the release of 24-week data from the second trial, which provides fresh data to support the hypothesis that filgotinib can succeed as a once-daily monotherapy. AbbVie now has a window in which to go over the data and assess whether filgotinib is the drug to fill the imminent Humira-shaped hole in its balance sheet.
University of California, San Diego, professor Arthur Kavanaugh, the principal investigator for the DARWIN 2 study that reported data this week, is optimistic about the future of filgotinib. "The DARWIN 2 24-week data clearly show the efficacy of this compound in rheumatoid arthritis," he said in a release. "In addition, the safety profile is quite notable. The increase in hemoglobin and lack of lymphocyte reduction suggest that there can be differentiation of various safety signals among different JAK inhibitors."
The comparison of filgotinib to other JAK inhibitors is something AbbVie may look at in the coming weeks. AbbVie has its own JAK inhibitor, ABT-494, coming down the pipeline, but it has yet to advance beyond a Phase II dose-finding study. Investors are hoping the extra time it will take to bring ABT-494 to patients--in which AbbVie could lose market share--and uncertainty over whether its clinical data will be as impressive as those generated by filgotinib will lead the Big Pharma to conclude that it cannot afford to pass up on the buy-in opportunity.
- read the release