AbbVie enters latest gastrointestinal drug race

AbbVie is making strategic moves in the gastrointestinal disease drug landscape by securing rights to an innovative antibody drug from China-based FutureGen Biopharmaceutical for $150 million in immediate and near-term payments. This drug targets TL1A, a molecule implicated in heightened immune responses in inflammatory bowel disease (IBD). AbbVie is aligning itself with industry giants like Merck, Roche, Teva, and Sanofi, which have collectively invested billions in acquiring TL1A-targeting drugs.

Announced on Thursday, the deal grants AbbVie global rights to the drug, named FG-M701. As part of the agreement, AbbVie will oversee its development, manufacturing, and commercialization. FutureGen stands to earn up to $1.56 billion more if specific development, regulatory, and sales milestones are met.

FG-M701 could serve as a successor to AbbVie's current blockbuster antibody drugs, Humira and Skyrizi, both of which are used to treat Crohn's disease and ulcerative colitis. While Humira's main patents have expired, leading to biosimilar competition, Skyrizi is expected to remain secure through 2033. FG-M701 is still in the pre-clinical stage, meaning it is years away from reaching the market, but it could be well-positioned to launch as Skyrizi's market exclusivity ends.

Despite the availability of medications like Skyrizi, Humira, and Johnson & Johnson's Stelara, a significant number of patients with Crohn's disease and ulcerative colitis do not respond to these treatments or achieve lasting remission. This has driven pharmaceutical companies to explore new mechanisms of action, including targeting TL1A.

In some cases, AbbVie's competitors have made even larger investments to acquire TL1A-targeting drugs. Merck & Co. spent nearly $11 billion to acquire Prometheus Biosciences for an experimental drug that has completed Phase 2 testing. Roche invested $7.1 billion to purchase a Roivant-Pfizer joint venture with a drug at a similar stage of development. Additionally, Sanofi paid Teva $500 million to collaborate on a TL1A medicine.

Even smaller biotech companies are entering the TL1A drug market. Spyre Therapeutics, for instance, raised $180 million to advance a TL1A agent and another candidate into human testing this year.

AbbVie's interest in FG-M701 underscores its strategy to maintain a strong foothold in the treatment of inflammatory bowel diseases. While current treatments like Humira and Skyrizi have been successful, the company recognizes the need for innovative approaches to address the unmet medical needs of patients who do not respond to existing therapies. The acquisition of rights to FG-M701 could provide a next-generation solution to these challenges, ensuring AbbVie remains competitive in the evolving pharmaceutical landscape.