Galapagos NV and Gilead Sciences to collaborate on Phase III development and commercialisation of filgotinib for inflammatory disease indications.

Galapagos NV and Gilead Sciences, Inc. announced that the companies have entered into a global partnership for the development and commercialization of the JAK1-selective inhibitor filgotinib (GLPG 0634) for inflammatory disease indications. Galapagos will receive an upfront payment of $725 million consisting of a license fee of $300 million and a $425 million equity investment in Galapagos. In addition, Galapagos is eligible for payments up to $1.35 billion in milestones, with tiered royalties starting at 20% and a profit split in co-promotion territories.

Phase II trial data show that filgotinib has the potential to be an effective and well-tolerated oral therapy for patients with rheumatoid arthritis (RA) (DARWIN studies: DARWIN1, DARWIN2 and DARWIN3) and Crohn’s disease (FITZROY study). The companies will start Phase III trials in RA and Crohn’s in 2016 pending the successful outcome of discussions with regulatory authorities.

Under the terms of the agreement, the companies will collaborate jointly on the global development of filgotinib starting with the initiation of Phase III trials in RA. Galapagos will co-fund 20 percent of global development activities and Gilead will be responsible for manufacturing and worldwide marketing and sales activities. Galapagos has the option to co-promote filgotinib in the UK, Germany, France, Italy, Spain, Belgium, the Netherlands and Luxembourg, in which case the companies will share profits equally .

Comment: The new agreement must come as a relief to Galapagos as AbbVie recently withdrew from a collaboration relating to filgotinib preferring to advance ABT-494, its internally developed investigational selective JAK1 inhibitor.