AbbVie and Galapagos said today they will extend their potential billion-dollar-plus clinical development collaboration of GLPG0634 beyond rheumatoid arthritis (RA), for which the companies are about to launch a Phase IIb trial, to include Crohn's disease as well.
Galapagos will fund a Phase IIa/b study of GLPG0634, with the goal of bringing the oral Janus kinase (JAK) inhibitor for JAK1 quickly into a Phase III trial. The Phase II study will measure both the drug candidate’s induction of disease remission and early maintenance of beneficial effects in Crohn's disease. The 20-week study of 180 Crohn's disease patients will start early next year, and take place at the same time as the Phase IIb RA trial.
In return for completion of the Phase II Crohn’s study—expected to occur in the second quarter of 2015—AbbVie will pay Galapagos $50 million, then fund and take over clinical development beyond Phase II, including regulatory and commercialization activities.
As for the rheumatoid arthritis study, AbbVie said it will license the program upon successful completion of the Phase IIb trial, and assume sole responsibility for Phase III clinical development and global manufacturing.
"Our experience within gastroenterology, combined with a novel alternative treatment for this disease, may provide a greater benefit to patients in the future," Scott Brun, M.D., vp, pharmaceutical development, AbbVie, said in a statement.
No other terms of the expanded collaboration were disclosed by the companies. AbbVie is the branded-drug spin-off of Abbott Laboratories, which last year paid Galapagos $150 million up-front for rights to develop and commercialize GLPG0634. At the time, Abbott also agreed to license the RA program for a one-time $200 million fee upon completion of Phase II studies, if the studies met certain pre-agreed criteria.
Abbott also agreed to pay Galapagos up to $1 billion in additional payments tied to achieving undisclosed developmental, regulatory, commercial, and sales-based milestones, plus tiered double-digit royalties on net sales upon commercialization. Belgian-owned Galapagos retains co-promotion rights to GLPG0634 in Belgium, the Netherlands, and Luxembourg.
GLPG0634 is one of five Galapagos pipeline molecules being studied for inflammatory indications, all with at least preliminary data scheduled for release by mid-2015 or earlier. One of those five is another selective JAK1 inhibitor in Phase II studies for lupus and psoriasis, GSK2586184 (formerly GLPG0778), in-licensed by GlaxoSmithKline in 2012.
Galapagos is also developing a third selective JAK1 inhibitor, GLPG0187, which is a novel integrin receptor antagonist currently in a Phase Ib patient study in metastasis. Another drug candidate, GLPG0974, is the first inhibitor of GPR43 to be evaluated clinically for the treatment of IBD, in a program that is currently in a proof-of-concept Phase I study.
AbbVie's pipeline includes mid- to late-stage clinical programs for diseases that include hepatitis C, rheumatoid arthritis, psoriasis, multiple sclerosis, Alzheimer's disease, Parkinson's disease, axial spondyloarthritis, multiple myeloma, and endometriosis.