Galapagos Ends Long-Running R&D Inflammation Pact With Janssen Pharmaceutica N.V.

Galapagos Ends Long-Running R&D Inflammation Pact With Janssen Pharmaceutica N.V.
March 17, 2015
By Alex Keown, Breaking News Staff

MECHELEN, Belgium, -- Galapagos NV and Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson , are terminating their eight year inflammation alliance, the companies announced Tuesday.

In addition, Galapagos, a clinical stage biotechnology company, will retain the rights to the experimental drug GLPG1690, a selective autotaxin inhibitor. The company said the retention of GLPG1690 will be a strong addition to its “growing proprietary pipeline.” Galapagos has successfully completed a First-in-Human Phase I trial for GLPG1690 and is preparing a Phase II clinical trial in idiopathic pulmonary fibrosis (IPF). Officials said there is an unmet need in IPF, and pre-clinical trials are showing GLPG1690 has the potential to be a competitive drug.

GLPG1690 is a selective inhibitor of autotaxin. In a Phase I study in healthy human volunteers, GLPG1690 demonstrated favorable safety and tolerability, as well as a strong pharmacodynamic signal implying target engagement. Galapagos is preparing a Phase II study in IPF, which will be filed for approval before the end of 2015, the company said in a press release.

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. IPF affects about 128,100 people in the United States, with about 48,000 new cases diagnosed annually. Approximately 40,000 people die each year from IPF, the same rate as breast cancer, according to the Coalition for Pulmonary Fibrosis.

Galapagos and Janssen partnered in 2007 and generated three clinical molecules, two of which are now proprietary Phase II assets of Galapagos: GLPG1205 and GLPG1690.

In December Galapagos announced it had retained full rights to GLPG1205 from Janssen. GLPG1205 works on GPR84, a mechanism developed by Galapagos for Inflammatory Bowel Diseases. G-coupled protein receptor 84 (GPR84) is a free fatty acid protein involved in the regulation of macrophages, monocytes and neutrophils in the human immune system. Galapagos identified GPR84 as playing a key role in inflammation.

In 2008 the two companies allied to apply Galapagos' proprietary adenoviral platform to identify novel drug targets for the development of cancer therapies. BioFocus DPI, Galapagos’ service division, and Jansen teamed to perform assay development, screening of the SilenceSelect and FLeXSelect adenoviral libraries, and target validation.

In its current pipeline Galapagos has three Phase II programs, two Phase I trials, five pre-clinical studies, and 25 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications.

Galapagos has an agreement with AbbVie for the development and commercialization of filgotinib, an oral selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase IIB studies in RA and in Phase II for Crohn's disease.

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