Galapagos scraps applications for Jyseleca in Europe and slashes sales projection

And the hits just keep on coming for Galapagos.

The Belgium biotech has decided, based on the results of a phase 3 study, not to submit a Marketing Authorization Application (MAA) in Europe for Jyseleca (filgotinib) in Crohn’s disease.

The company also will not proceed with its MAA for filgotinib in ulcerative colitis (UC) in Switzerland. Galapagos revealed the moves in reporting its first-half earnings.

This is a major blow for Galapagos. For years, the company has been counting on the potential of its top drug to score in these lucrative indications.

Along with the moves, Galapagos has slashed its 2023 sales guidance for Jyseleca from 140-160 million euros ($154 million to $176 million) to 100-120 million euros ($110 million to $132 million). The drug is approved in Europe for rheumatoid arthritis and UC.

“The market and competitive landscape for the JAK class in Europe has changed significantly over the past six months,” Galapagos Chief Financial Officer and Chief Operating Officer Thad Huston said in a release. “We are in the process of evaluating strategic options for Jyseleca.”

The good news for Galapagos is on its balance sheet. The company has 3.9 billion euros ($4.3 billion) on hand to deploy for business development.

“There’s a tremendous opportunity for us to really drive an innovative approach to bringing life-saving therapies to patients,” Huston said in a conference call on Friday morning. “We’re doing some things that the other players are not doing that is really exciting.”

CEO Paul Stoffels, a Johnson & Johnson veteran known for his acumen in identifying promising drugs, took over at Galapagos in March of last year and quickly acquired two CAR-T companies for a combined $251 million.

On the call Friday, Stoffels said that the deals he is seeking will be for differentiated products and must be global. He said his timeline for making moves will be over the next 18 months.

Once a biotech powerhouse so attractive that it drew a $5 billion partnership with Gilead in 2019, Galapagos has seen its value plummet.

After its share price peaked in early 2020 at $268, shares have declined to $41.75. The downfall began three years ago when the FDA rejected filgotinib in rheumatoid arthritis for toxicity issues.

In November of last year, Galapagos executed a pipeline trim and the loss of 200 roles. The move was part of Stoffels’ strategy to concentrate on immunology and oncology “focusing on best-in-disease validated targets in our strategic therapeutic areas with shorter time-to-patient potential.”