Abbott and Galapagos Announce Global Collaboration for Novel Oral Therapy, GLPG0634, in Phase II to Treat Autoimmune Diseases

Selective JAK1 inhibitor in Phase II clinical development for rheumatoid arthritis

02-Mar-2012 - USA

Abbott  and Galapagos announced that they have entered into a global collaboration to develop and commercialize an oral, next-generation JAK1 inhibitor in Phase II development with the potential to treat multiple autoimmune diseases.

GLPG0634 is a highly selective JAK1 inhibitor that Galapagos is developing for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases.  The Janus kinases (JAK) are a family of enzymes that play a key role in the signaling mechanism used by a number of cytokines that are involved in autoimmune diseases.  In previously reported results from a 4-week Phase IIa study, GLPG0634 demonstrated efficacy measures among the best reported in RA.  All patients completed the study, and few experienced any side effects.  No anemia, change in blood pressure or lipids were observed.  An additional Phase IIa dose-range finding study with GLPG0634 is expected to begin shortly.

Under the terms of the agreement, Abbott will make an initial upfront payment of $150 million for rights related to the global collaboration.  Upon successful completion of the RA Phase II studies, Abbott will license the program for a one-time fee of $200 million if the studies meet certain pre-agreed criteria.  Abbott will assume sole responsibility for Phase III clinical development and global manufacturing.  Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, Galapagos would be eligible to receive additional milestone payments from Abbott, potentially amounting to $1.0 billion, in addition to tiered double-digit royalties on net sales upon commercialization.  Galapagos retains co-promotion rights in Belgium, the Netherlands and Luxembourg.

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