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Galapagos selects second component of its investigational cystic fibrosis combination treatment


December 12, 2014 - London

  • Novel corrector GLPG2222 together with potentiator GLPG1837 offers therapy for most CF patients, potentially superior to current therapies under development
  • Start of Phase 1 with first novel corrector expected before end 2015
  • Final component for triple combination therapy expected to be nominated in 2015

Mechelen, Belgium; 12 December 2014 - Galapagos NV (Euronext: GLPG) announced today that it nominated a first pre-clinical candidate corrector GLPG2222 for clinical development in its cystic fibrosis (CF) program. This corrector, in combination with GLPG1837, forms the core of Galapagos' future combination therapy for the most common mutation in cystic fibrosis. The Galapagos combination has shown higher efficacy in pre-clinical studies than other therapies currently under clinical development.

Identification of novel, potent, and efficacious corrector candidates is part of building a triple combination therapy with Galapagos' potentiator GLPG1837, currently entering Phase 1 safety studies. Galapagos and AbbVie have developed multiple, novel correctors that in triple combination with GLPG1837, show >40% restoration of healthy (WT CFTR) activity in cells derived from CF patients with the delF508 mutation. Furthermore, the Galapagos-AbbVie corrector series compounds show good drug-like properties, which support further pre-clinical development. From these series, Galapagos selected a first pre-clinical candidate, the first corrector building block which together with potentiator GLPG1837, forms a solid basis for future triple combination developments. Galapagos is entering Phase 1 with GLPG1837 this month.

"Galapagos and AbbVie have five different chemical series with several excellent compounds from which to choose its novel CF correctors. The novel corrector nominated today forms the second of three ingredients needed for building our triple combination therapy. This selection brings us a big step closer to realizing our ambition of developing novel and best-in-class therapies for CF. The Galapagos-AbbVie team is working on selecting a second corrector candidate from our series to augment further the CFTR delF508 levels obtained by the dual GLPG1837/corrector combination," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.

Galapagos initiated its research in CF in 2005. 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.

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 three Phase 2 studies, two Phase 1 studies, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. In the field of inflammation, AbbVie and Galapagos signed an agreement for the development and commercialization of GLPG0634. 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 in Phase 2 in Crohn's disease. Galapagos has another selective JAK1 inhibitor, 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 has completed a Proof-of-Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and has completed Phase 1. GLPG1690 is a first-in-class compound that targets pulmonary diseases and is currently in a Phase 1 study. AbbVie and Galapagos signed an agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is in Phase 1. The first Galapagos corrector GLPG2222 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service subsidiary Fidelta, has around 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com

CONTACT

Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
ir@glpg.com

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.





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Source: Galapagos NV via Globenewswire

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