Date: 2015-09-25
Type of information: Termination of an agreement
Compound: GLPG0634
Company: Galapagos (Belgium) AbbVie (USA - Il)
Therapeutic area: Autoimmune diseases – Digestive diseases - Inflammatory diseases - Rheumatic diseases
Type agreement: termination of the agreement
Action mechanism: GLPG0634 is a highly selective JAK1 inhibitor. 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.
Disease: rheumatoid arthritis and other autoimmune diseases, Crohn's disease
Details: * On February 29, 2012, Abbott and Galapagos have announced that they have entered into a global collaboration to develop and commercialize GLPG0634, an oral, next-generation JAK1 inhibitor in Phase II development with the potential to treat multiple autoimmune diseases. In previously reported results from a 4-week Phase IIa study, GLPG0634 demonstrated efficacy measures among the best reported in rheumatoid arthritis. 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. Galapagos expects to deliver to Abbott a complete Phase II package in 2014.
Financial terms: 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.* On May 17, 2013, Galapagos and AbbVie have announced an extension of their GLPG0634 clinical development collaboration to include Crohn's disease. Galapagos will fund and complete a Phase 2 program in Crohn's disease, which is designed to facilitate rapid progression into Phase 3. Upon successful completion of the study, expected in Q2 2015, AbbVie will pay Galapagos $50 million. The terms of the collaboration extension are in addition to previously agreed upon financial terms. AbbVie will be responsible for funding and performing clinical development beyond Phase 2, and completing regulatory and commercialization activities.
Latest news: * On September 25, 2015, Galapagos announced that Abbvie has notified the company of termination of the agreement on filgotinib.* On May 17, 2013, Galapagos and AbbVie have announced an extension of their GLPG0634 clinical development collaboration to include Crohn's disease. Galapagos will fund and complete a Phase 2 program in Crohn's disease, which is designed to facilitate rapid progression into Phase 3. Upon successful completion of the study, expected in Q2 2015, AbbVie will pay Galapagos $50 million. The terms of the collaboration extension are in addition to previously agreed upon financial terms. AbbVie will be responsible for funding and performing clinical development beyond Phase 2, and completing regulatory and commercialization activities.Galapagos will start an innovative 20-week, Phase 2A/B study with GLPG0634 in 180 patients suffering from Crohn's disease by early 2014. The study will measure both induction of disease remission and early maintenance of its beneficial effects in Crohn's disease, and is expected to read out topline results in Q2 2015. This Phase 2 study in Crohn's will be performed in parallel with the Phase 2B study in rheumatoid arthritis (RA).
