Galapagos NV (GLPGF.PK, GLPYY.PK) announced that the company and AbbVie Inc. (ABBV) have extended their GLPG0634 clinical development collaboration to include Crohn's disease.
Galapagos said it 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 the second-quarter of 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 noted that it will start an innovative 20-week, Phase 2A/B study with GLPG0634 in 180 patients suffering from Crohn's disease by early 2014.
According to the company, 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 the second-quarter of 2015. This Phase 2 study in Crohn's will be performed in parallel with the Phase 2B study in rheumatoid arthritis or RA.
Crohn's disease is a type of inflammatory bowel disease in which the well-controlled balance of the intestinal immune system is disturbed. The disease causes ulcerations of the small and large intestines in particular, but may affect any part of the digestive system from mouth to anus. Driven by new therapies in development, Decision Resources estimates that the market for Crohn's disease treatment will grow from $3.8 Billion in 2011 to $5.6 Billion in 2021.
Separately, Galapagos announced that the operational and financial results achieved thus far in 2013 encourage the company to retain full year 2013 Group revenues guidance of 160 million euros.
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