Galapagos selects pre-clinical candidate for cystic fibrosis

• Novel potentiator shows more activity in pre-clinical studies than market leader Kalydeco ®
• Start of Phase 1 expected before end 2014

Galapagos NV (Euronext: GLPG) announced today that it nominated a pre-clinical candidate potentiator for clinical development in its cystic fibrosis (CF) program.

Galapagos has developed multiple, novel potentiators that, in pre-clinical research, show high potency and superior efficacy in comparison to Kalydeco® (ivacaftor),the only approved disease-modifying CF drug on the market today. Furthermore, the Galapagos compounds show good drug-like properties, which support further pre-clinical development. The clean safety profile[1] of these compounds should allow the combination with antibiotics frequently prescribed for CF patients.  From these series, Galapagos selected GLPG1837 as pre-clinical candidate and expects to start the first clinical trial before end 2014.  Galapagos recently filed a patent application covering GLPG1837, with the expected patent life until at least 2034.

"Galapagos had several excellent compounds to choose from among its novel CF potentiators.  GLPG1837 forms the first part of our strategy to develop novel and best-in-class therapies for CF.  The Galapagos-AbbVie team is now fully ramped up to progress our correctors, which are needed in combination with the potentiator to address the unmet need of most CF patients," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. 

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.  Under the terms of the agreement, AbbVie made an upfront payment of $45 million to Galapagos.  Upon successful completion of pre-determined success milestones, AbbVie and Galapagos will share responsibility and funding for Phase III clinical development.  Galapagos is eligible to receive up to $360 million in total additional payments for developmental and regulatory milestones, sales milestones upon the achievement of minimum annual net sales thresholds and additional double-digit royalty payments on net sales.

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, delF508 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.

About Galapagos 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, five 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

Contact

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Kalydeco® is a registered trademark of Vertex Pharmaceuticals Incorporated [1] supported by high selectivity, and the absence of CYP inhibition

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