NORTH CHICAGO, Ill.—Galapagos NV and AbbVie have announced aglobal alliance for the discovery, development and commercialization of novelpotentiator and combination therapies to treat cystic fibrosis. The twocompanies will collaborate to pool their technologies and resources in pursuitof oral drugs that target the main mutations seen in cystic fibrosis, includingG551D and F508del, the latter of which is the most common mutation, seen in 90percent of cystic fibrosis patients. This alliance's goal is to identifycompounds that can correct defects in the expression of and/or increase theactivity of the main mutations in the cystic fibrosis transmembrane regulator(CFTR) protein.
"Galapagos is very pleased to join forces with AbbVie inthis exciting new area of CF. Our programs in CF show promise," said Onno vande Stolpe, CEO of Galapagos, in a press release. "Partnering with AbbVie allowsus to ramp up our commitment significantly, share development risk andexpertise and increase our chances of bringing best-in-class therapies to CFpatients."
Per the terms of this agreement, AbbVie will pay Galapagos$45 million up front for rights related to the alliance. If pre-determinedsuccess milestones are reached, the partners will share responsibility andfunding for Phase III clinical development. Galapagos stands to receive up to$360 million in additional developmental and regulatory milestones, salesmilestones if minimum annual net sales thresholds are met and double-digitroyalties on net sales of resulting products.
AbbVie and Galapagos will develop potentiators andcorrectors discovered by Galapagos, and hope to begin Phase I clinical studiesby the end of 2014. Should clinical development be successful and resultingproducts gain regulatory approval, AbbVie will assume responsibility forcommercial activities, while Galapagos will retain exclusive rights in Chinaand South Korea, as well as co-promotion rights in Belgium, the Netherlands andLuxembourg.
"We're pleased to enhance our partnership with Galapagos toinclude research in cystic fibrosis, a debilitating disease with significantunmet medical need. Our knowledge of the patient experience, combined withinnovative advances in the understanding of disease etiology, offers thepotential for new transformational treatments," Jim Sullivan, Ph.D., vicepresident of pharmaceutical discovery at AbbVie, commented in a statement.
This alliance comes a few months after the companiesannounced that they were extending their GLPG0634 clinical developmentcollaboration to include Crohn's disease. GLPG0634 is an orally available novelJAK inhibitor developed by Galapagos. The compound specifically targets JAK1,and is being developed in rheumatoid arthritis. Under the extension, Galapagoswill fund and complete a Phase II program of the drug candidate in Crohn'sdisease. Upon the study's completion, which is slated for the second quarter of2015, AbbVie will pay Galapagos $50 million, and thereafter will be responsiblefor funding and clinical development beyond Phase II, in addition to beingresponsible for regulatory and commercialization activities.
SOURCE: Galapagos press release