Galapagos (GLPG) Reports Positive Data on GLPG1837
Galapagos NV GLPG announced positive top-line data from a phase I randomized, double-blind, placebo-controlled study on GLPG1837 for the treatment of patients with class III mutation in cystic fibrosis.
Data revealed that the candidate was safe and generally well-tolerated. A phase II study is expected to be initiated by the year end.
According to information provided by the company, approximately 30,000 patients and 80,000 patients are affected by cystic fibrosis in the U.S. and worldwide, respectively.
Galapagos expects to develop GLPG1837 in combination with other candidates in its pipeline, as a potential triple combination therapy for class II cystic fibrosis patients.
We remind investors that Galapagos has a collaboration agreement with AbbVie Inc. ABBV to discover, develop and commercialize potentiator and combination therapies for cystic fibrosis. Under the terms of the agreement, Galapagos received an upfront payment of $45 million from AbbVie. In addition, the company is eligible to receive up to $360 million as developmental, regulatory and sales milestones upon the achievement of minimum annual net sales thresholds, upon approval. The company is also entitled to receive double-digit royalties on net sales.
We note that Galapagos has two candidates under this collaboration – GLPG1837 and GLPG2222. In Dec 2014, the company announced the initiation of the first phase I study on GLPG1837, which triggered a milestone payment worth $10 million from AbbVie. A phase I study on GLPG2222 is expected to be initiated by the year end.
Meanwhile, the company continues to progress on its other candidates. Currently, the company is evaluating filgotinib in a phase II study (data expected in Dec 2015) for the treatment of patients with Crohn’s disease. In addition, a phase III study on filgotinib for the treatment patients with rheumatoid arthritis (RA) is expected to be initiated by early 2016.
Another candidate in the company’s pipeline, GLPG1205, is being evaluated in a phase II proof-of-concept study (data expected in the fourth quarter of 2015) for the treatment of patients with ulcerative colitis.
Galapagos carries a Zacks Rank #2 (Buy). Other favorably ranked stocks in the health care sector include Nexvet Biopharma Public Limited Company NVET and Anika Therapeutics Inc. ANIK, each sporting a Zacks Rank #1 (Strong Buy).
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