Mechelen, Belgium; 13 January 2014 - Galapagos NV (Euronext: GLPG) announced today that it has been awarded a €2.9 million grant from the Flemish agency for Innovation by Science and Technology (IWT) for cystic fibrosis (CF) research. The goal of this 3-year project is to identify and progress multiple promising CF therapies towards pre-clinical candidates.
The goal of the IWT-funded program is to progress correctors into pre-clinical development and gain better insight in the mode of action of Galapagos' potentiator and corrector molecules, thereby understanding better their therapeutic value. Galapagos recently announced the selection of a pre-clinical candidate potentiator, GLPG1837, the first part of the combination therapy needed to address the needs of most CF patients. This IWT grant will fund research toward finding correctors, which are needed in combination with GLPG1837. Galapagos will collaborate in this project with Professor Dr Christiane De Boeck from the Catholic University of Leuven, and the research group of Professor Dr Ineke Braakman at Utrecht University.
"We are very pleased with the enthusiastic support from the IWT for our innovative research in cystic fibrosis," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Today's grant will add more tools to our exciting new approach in finding correctors."
Galapagos initiated its research in CF in 2005 as part of a collaboration with the Cystic Fibrosis Foundation. In September 2013 Galapagos signed an agreement with AbbVie in which they will work collaboratively to develop and commercialize oral drugs that address the main mutations in CF patients, including F508del and G551D. In December 2013, Galapagos selected GLPG1837 as a pre-clinical candidate and expects to start the first clinical trial before end 2014. A corrector pre-clinical candidate is expected to be nominated before end 2014, with clinical trials starting at the end of 2015.
About Cystic Fibrosis
Cystic fibrosis (CF) is a hereditary disease of the entire body which leads to severe disability and early death in many cases. Symptoms include frequent lung infections, sinus infections, poor growth, and diarrhea. The cause is a defect in a gene which encodes for cystic fibrosis transmembrane conductance regulator (CFTR), a protein which regulates components of sweat, mucus, and digestive juices. CF affects approximately 70,000 people worldwide. Patient symptoms are treated with antibiotics and other medicines. There currently is no cure for the disease, and the predicted median age of survival is in the late 30s. New therapies in development for the main mutation, F508del affecting 70% of CF patients, involve combining two drugs: a corrector to restore the mutation plus a potentiator to allow efficient opening of the CF channel.
The agency for Innovation by Science and Technology (abbreviated as IWT) is the government agency founded in 1991 by the Flemish Government to support technological innovation projects in Flanders. Each year IWT distributes about EUR 300 million in subsidies for innovation projects to companies, organizations, research and educational institutions in Flanders. In addition to financial support, IWT also assists companies by, for instance helping them find the right information or the right partners at home or abroad, providing assistance with the preparation of projects for European programmes and with technology transfer throughout Europe. IWT also has an important coordination mandate aimed at promoting close cooperation among all the actors involved in technological innovation in Flanders. For more information, please visit http://www.iwt.be or call +32 2 432 42 00.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising of six Phase 2 studies (three led by GSK), one Phase 1 study, six pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
AbbVie and Galapagos signed an agreement in CF where they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. Potentiator GLPG1837 is at the pre-clinical candidate stage. In the field of inflammation, AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after Phase 2B. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and about to enter Phase 2 studies in Crohn's disease. Galapagos has another selective JAK1 inhibitor in Phase 2 in ulcerative colitis, psoriasis, and lupus, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1 studies.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has around 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
Galapagos forward-looking statements
This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.