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AbbVie and Galapagos Extend GLPG0634 Collaboration to Include Crohn's Disease
Date:5/16/2013

NORTH CHICAGO, Ill. and MECHELEN, Belgium, May 17, 2013 /PRNewswire/ -- Galapagos NV (Euronext: GLPG) and AbbVie (NYSE: ABBV) announced today 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 disease will be performed in parallel with the Phase 2B study in rheumatoid arthritis (RA).

Crohn's disease is a serious chronic, inflammatory autoimmune disease of the gastrointestinal (GI) tract that affects millions of people worldwide, including more than one million people in Europe and more than 500,000 people in the U.S.  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.  JAK inhibitors, with their immune-modulating effects, have the potential to become an effective treatment option for this disease.  By inhibiting JAK1, GLPG0634 blocks signaling for several key pro-
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