Mechelen, Belgium; 17 March 2015 - Galapagos NV (Euronext: GLPG) announced that Janssen Pharmaceutica NV and Galapagos have mutually agreed to terminate the inflammation alliance and option agreements between the companies. Galapagos views the molecules emerging from the alliance as strong additions to its growing proprietary pipeline. Among others, all rights to candidate drug GLPG1690, a selective autotaxin inhibitor, return to Galapagos. Galapagos has successfully completed a First-in-Human Phase 1 trial for GLPG1690 and is preparing a Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF).
"We are pleased to regain the rights to GLPG1690 to pursue the most suitable clinical application of autotaxin inhibition. There is a large unmet medical need in IPF, and our pre-clinical data with GLPG1690 supports its potential as a competitive and novel approach in this disease area," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "The alliance with Janssen has been underway since October 2007 and has generated three clinical molecules, two of which are now proprietary Phase 2 assets of Galapagos: GLPG1205 and GLPG1690. This program is a valuable component of our development portfolio, and regaining the rights is a next step in our transformation into a mature biotech company with a proprietary product pipeline."
Galapagos identified autotaxin as playing a key role in inflammation, using an inflammation assay in its unique target discovery platform. Pharmacology and translational studies published by other parties in the literature since then suggest autotaxin may play a key role in metabolic disease, arthritic pain, oncology, and lung disease.
GLPG1690 is a potent and selective inhibitor of autotaxin. In a Phase 1 study in healthy human volunteers, GLPG1690 demonstrated favorable safety and tolerability, as well as a strong pharmacodynamic signal implying target engagement. Galapagos is currently preparing a Phase 2 study in IPF, to be filed for approval before the end of 2015.
Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized by a progressive decline in lung function. Pulmonary fibrosis involves scarring of lung tissue and is the cause of shortness of breath. Fibrosis is usually associated with a poor prognosis. The term "idiopathic" is used because the cause of pulmonary fibrosis is still unknown. Estimated incidence of IPF is up to 16.3 per 100,000 persons in the US and 7.4 per 100,000 persons in Europe, with approximately 30,000-35,000 new patients diagnosed with IPF worldwide each year. The goals of treatment in IPF are essentially to reduce the symptoms, slow down disease progression, reduce acute exacerbations, and prolong survival. Approved treatments thus far have improved the overall survival of IPF patients, but unwanted side effects with these treatments are common, presenting an unmet need for effective treatments with safer side effect profiles.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, with a pipeline comprising three Phase 2 programs, two Phase 1 trials, five pre-clinical studies, and 25 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. In the field of inflammation, AbbVie and Galapagos signed a collaboration agreement for the development and commercialization of filgotinib. Filgotinib 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. GLPG1205, a first-in-class inhibitor of GPR84, is currently being tested in a Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690, a first-in-class inhibitor of autotaxin, has shown favorable safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic pulmonary fibrosis. AbbVie and Galapagos also signed a collaboration agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and corrector GLPG2222 is at the pre-clinical candidate stage. The Galapagos Group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
Galapagos forward-looking statements
This release may contain forward-looking statements, including, without limitation, expectations regarding the commercial potential of our product candidates generally, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," "continues," "we believe," "we intend," 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. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements and estimating the commercial potential of our product candidates. 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.