An FDA rejection of Galapagos NV's rheumatoid arthritis (RA) drug filgotinib, announced Aug. 18, was "disappointing and unexpected," CEO Onno van de Stolpe said, adding that "there is so much more" to his company's story and pipeline. Gilead Sciences Inc., the Belgian company's partner and a substantial backer of both the drug and the pipeline, said it would "evaluate the points raised" by the CRL, but continued to believe in the drug.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
Gilead Sciences Inc. and partner Galapagos NV touched off a round of Wall Street chin-scratching as they disclosed phase IIb/III data showing that JAK1 inhibitor filgotinib in ulcerative colitis (UC) at the 200-mg dose achieved all primary endpoints in the study called Selection.
Filgotinib (GLPG-0634) has the potential to be a blockbuster drug, according to Cortellis Drugs to Watch analysis, but it may take a few approvals in various indications to reach the coveted mark of $1 billion in annual sales.
No matter how effective it is, a drug is worthless if the people who need it can’t afford it. That’s been almost an anthem for patients and policy wonks testifying before U.S. Congress on drug prices.
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
