In 2012, the global "blockbuster drug" changed hands — AbbVie's autoimmune disease monoclonal antibody Humira replaced Pfizer's lipid-lowering drug Lipitor, initiating more than a decade of dominance.However, the intersection of the two pharmaceutical giants is not limited to this.In November 2012, Pfizer's Xeljanz received FDA approval for the treatment of rheumatoid arthritis (RA), becoming the first approved JAK inhibitor for autoimmune diseases.And just in February of the same year, Abbott Laboratories licensed in a JAK inhibitor (development code GLPG0634, also known as Filgotinib) from Galapagos NV.Under the agreement, Abbott paid $150 million upfront and will pay another $200 million if the Phase II trial of RA successfully meets predetermined criteria. Abbott will take full responsibility for future Phase III studies and production. Galapagos will also receive $1 billion in development, regulatory, and sales milestones, along with tiered royalties in the double digits. The relevant rights to this deal were transferred to AbbVie (AbbVie), which was spun off from Abbott, in 2013.It is worth mentioning that GLPG0634 completed the Phase 2 Proof-of-Concept study for RA in November 2011, achieving the primary endpoint of ACR20, and began a Phase IIb clinical trial for RA in June 2013.In April 2015, Galapagos announced the results of two Phase IIb studies in RA patients with an incomplete response to methotrexate treatment after 12 weeks:DARWIN 1 Study: GLPG0634 as an add-on therapy to methotrexate (MTX) achieved the primary endpoint (ACR20) after 12 weeks of treatment. The two highest dose groups (QD and BID dosing) among the five dose groups reached the primary endpoint, all five dose groups achieved the secondary endpoint (ACR50), and only one dose group reached the second secondary endpoint (ACR70).DARWIN 2 Study: After 12 weeks of GLPG0634 monotherapy, all three dose groups (QD dosing) achieved the primary endpoint (ACR20) and secondary endpoint (ACR50), while only one dose group reached the second secondary endpoint (ACR70).At the same time, AbbVie's independently developed JAK inhibitor ABT-494 (upadacitinib), although lagging behind GLPG0634, also announced the results of two Phase IIb studies in September 2015. The BALANCE-I and BALANCE-II trials respectively evaluated ABT-494 in RA patients with an inadequate response to methotrexate or TNF inhibitors.All dose levels in the BALANCE-I and BALANCE-II clinical trials, except for the lowest of the five dose groups, achieved ACR20 at week 12. In patients with an incomplete response to TNF inhibitors, the ACR20 response rate was 73% and the ACR50 response rate was 44%. In patients with an incomplete response to MTX, the ACR20 response rate reached 82% and the ACR50 response rate reached 50%.Obviously, compared with the study in the same population (incomplete response to MTX treatment), ABT-494 is more effective than GLPG0634.After a thorough review of the existing data, AbbVie ultimately returned the rights to GLPG0634 to Galapagos and instead focused on developing its own ABT-494.AbbVie believes that "ABT-494 has the potential to become a best-in-class therapy, particularly among the most challenging patient populations with an incomplete response to TNF, a group that is growing and represents those who do not respond to current standard treatments… ABT-494 also offers a faster Phase III development pathway with less uncertainty."Not long after AbbVie and Galapagos parted ways, in December 2015, Galapagos reached a Filgotinib cooperation agreement with Gilead Sciences. Galapagos will receive an upfront payment of $725 million, including a $300 million license fee and a $425 million equity investment in Galapagos. In addition, Galapagos is eligible to receive up to $1.35 billion in milestone payments, as well as tiered royalties starting at 20% and profit sharing in co-promotion regions.Later, the FDA rejected Filgotinib's marketing application in the United States. Eventually, Galapagos and Gilead Sciences negotiated a split, and the Filgotinib agreement was transferred to Alfasigma. However, the product was approved for marketing in the EU and Japan under the brand name Jyseleca.AbbVie's upadacitinib was first approved by the FDA in the United States in August 2019 under the brand name Rinvoq. In 2023, its sales reached $3.97 billion, surpassing Pfizer's Xeljanz/Xeljanz XR annual sales peak, and it is still in a period of rapid growth.In the biopharmaceutical industry, licensing in projects is relatively easy, but making the decision to abandon them can be extremely difficult, especially after a licensed-in project has achieved phased success and tens or even hundreds of millions of dollars have been paid for it.The deal between AbbVie and Galapagos is undoubtedly one of the most classic cases, which is worth our reference.
Cover image source: pixabay
Copyright Statement/Disclaimer
This article is an authorized reprint.
This article is for information exchange purposes only and does not provide any commercial, medical, or investment advice.
The images, videos, fonts, music, and other materials in the article are either authorized genuine works purchased by PharmaTimes, or from the WeChat public image library, or taken from the company's official website/network. Some materials are used under the CC0 protocol, and the copyright belongs to the owner. PharmaTimes makes every effort to acknowledge the source.
If you have any questions, please contact us.
Sincerely grateful!
DrugTimes Official Website: www.drugtimes.cn
Contact Information:
Phone: 13651980212
WeChat: 27674131
Email: contact@drugtimes.cn
Click to read the original text and learn more!
