Galapagos and Gilead Sciences have both evolved since inking their R&D collaboration agreement in 2019. Separating Galapagos into two offers a way for that company to pursue its cell therapy strategy while also keeping the Gilead alliance alive, executives from both companies said.
Galapagos said the planned business separation will leave the legacy company free to focus on developing cell therapies for cancer. An accompanying corporate restructuring will shave Galapagos’s headcount by 40%.
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Galapagos is a latecomer to CAR T-therapy, but the drugmaker hopes its technology for producing cell therapies at a clinical site will help it stand out. Galapagos has encouraging preliminary data from two early-stage programs and it just begun Phase 1/2 testing of its third cancer cell therapy.
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
The European Commission and Japan's Ministry of Health, Labor and Welfare approved filgotinib, marketed under the name Jyseleca, for rheumatoid arthritis. The drug is partnered in Japan with Eisai. The FDA rejected the drug last month.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
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An analyst wrote that while filgotinib's profile appears clean overall, even minor safety imbalances could derail its approval, while a slight imbalance in the number of deaths between the Phase III study arms could also attract scrutiny.
The collaboration includes six drugs in development and more than 20 in preclinical development. It also amends an existing four-year-old partnership the two companies had regarding the autoimmune disease drug filgotinib.
The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.
Whether the FDA requires completion of a study to look at testicular toxicity before approval could dictate whether the drug launches next year or as late as 2022, an analyst wrote.
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