Galapagos NV, a Belgian biopharmaceutical company, and Gilead Sciences report that the US Federal Trade Commission has provided early termination of the waiting period for the global partnership agreement on filgotinib under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. In December 2015, Gilead Sciences and Galapagos formed a global partnership for the development and commercialization of the JAK1-selective inhibitor , filgotinib, for inflammatory disease indications. The deal is expected to close by the end of the month.

Upon closing, Galapagos will receive an upfront license fee of $300 million, and Gilead will make a $425 million equity investment in Galapagos by subscribing for shares at a price of EUR 58 per share. After the issuance of the shares, Gilead will own approximately 15% f the outstanding share capital of 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) and Crohn's disease. 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% 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. If Galapagos exercises its option to co-promote in Belgium, the Netherlands or Luxembourg, it will also book sales in these countries.

Source: Gilead Sciences