Date: 2013-11-22
Type of information: Milestone
Compound: GLPG0634 (filgotinib)
Company: Galapagos (Belgium) Gilead Sciences (USA - CA)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Digestive diseases
Type agreement: development
commercialisation
Action mechanism: janus kinase inhibitor. Filgotinib is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. Filgotinib differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile.
Disease: Crohn's disease, rheumatoid arthritis
Details:
- • On January 19, 2016, Galapagos and Gilead Sciences announced the closing and entry into force of their global license and collaboration agreement on filgotinib. Under the terms of the agreement, the closing of this transaction triggers an upfront license fee payment of $300 million by Gilead to Galapagos. In addition, Gilead has made a $425 million (or €392 million) equity investment in Galapagos by subscribing for new shares at a price of €58 per share, including issuance premium. As a result, Gilead now owns 6,760,701 ordinary shares of Galapagos, representing 14.75 percent of the currently outstanding share capital of Galapagos.
- * On January 13, 2016, Galapagos and Gilead Sciences announced that the U.S. Federal Trade Commission provided early termination of the waiting period for their global partnership agreement on filgotinib under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. 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 €58 per share. After the issuance of the shares, Gilead will own approximately 15 percent of the outstanding share capital of Galapagos, depending on the $/€ exchange rate at closing.
- • On December 17, 2015, Galapagos and Gilead Sciences announced that the companies have entered into a global partnership for the development and commercialization of the JAK1-selective inhibitor filgotinib for inflammatory indications. Phase 2 trial data show that filgotinib has the potential to be an effective and well-tolerated oral therapy for patients with rheumatoid arthritis (DARWIN studies) and Crohn’s disease (FITZROY study). The companies will start Phase 3 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 3 trials in RA. Galapagos will cofund 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. If Galapagos exercises its option to co-promote in Belgium, the Netherlands or Luxembourg, it will also book sales in these countries.
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 €58 per share, which represents a 20% premium as compared to the average share price over the last 30 days. After the issuance of the shares, Gilead will own approximately 15% of the outstanding share capital of Galapagos, depending on the $/€ exchange rate at closing. Galapagos is eligible to receive further development, regulatory and commercial milestone payments up to $1.35 billion, plus tiered royalties on global sales starting at 20%, with the exception of the co-promotion territories where profits will be shared equally.
This transaction has been approved by the boards of both companies, and is subject to customary closing conditions and clearance under the Hart-Scott Rodino Antitrust Improvements Act.
Financial terms: 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 of up to $1.35 billion in milestones, with tiered royalties starting at 20% and a profit split in co-promotion territories.
Latest news:
- • On November 22, 2016, Galapagos reported the first dosing of a patient in the DIVERSITY Phase 3 study with filgotinib in Crohn's disease. The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure. In addition to the DIVERSITY study, Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016 and is expected to start the SELECTION Phase 2b/3 study in ulcerative colitis later this quarter.
Is general: Yes
