Galapagos (GLPG) Advances RA Drug Filgotinib To Phase III

Galapagos NV (NASDAQ:GLPG) announced the initiation of a phase III program (FINCH) on filgotinib for the treatment of rheumatoid arthritis (RA).

The program will comprise three studies that will evaluate the safety and efficacy of once-daily filgotinib (100 mg and 200 mg) in patients with RA, ranging from early-stage to biologic-experienced.

FINCH 1, an adalimumab-controlled study, will evaluate filgotinib in combination with methotrexate (MTX) in patients who have had inadequate response to MTX, while FINCH 2 will include patients on conventional disease-modifying anti-rheumatic drugs (cDMARD), who have had an inadequate response to biological treatment. FINCH 3, on the other hand, will enroll MTX-naïve patients to evaluate filgotinib in combination with MTX and monotherapy.

We note that competition in the RA market is stiff due to the presence of drugs like Acterma, Rayos and Xeljanz among others.

Galapagos has global partnership with Gilead Sciences, Inc. (NASDAQ:GILD) for the development and commercialization of filgotinib for inflammatory indications. Under the terms of the agreement, Galapagos will co-fund 20% of global development activities, while Gilead will be responsible for manufacturing, worldwide marketing and sales activities.

Meanwhile, the companies are also preparing to initiate studies on filgotinib in other indications, such as Crohn’s disease and ulcerative colitis, in the fourth quarter of 2016.

Given that Galapagos has no approved product in its portfolio yet, we expect investor focus to remain on updates pertaining to the development of the candidates in its pipeline.

Galapagos currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector include Actelion Ltd. (OTC:ALIOF) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . Both the stocks sport a Zacks Rank #1 (Strong Buy).

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