Novartis is further bolstering its preclinical pipeline and continuing its hunt for a Xolair successor, nailing down a licensing pact with Japanese biotech Kyorin that could be worth hundreds of millions of dollars.
Novartis is paying Kyorin $55 million upfront for exclusive global rights to develop, manufacture and commercialize KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria (CSU), Kyorin announced in a March 3 release (PDF). Kyorin could also net up to $777.5 million if certain milestones are met, according to the release.
The biotech retained the option to commercialize the asset in Japan, with Novartis holding its own option to co-promote the drug with the biotech in the country.
CSU is also known as chronic hives. While many people experience hives at some point in life, CSU is characterized by recurring swollen, itchy blotches that can persist for longer than six weeks.
Patients with chronic hives can also develop psychological symptoms such as sleep deprivation, anxiety and depression, according to the release.
Novartis is already a major player in the chronic hives market with Roche-partnered Xolair (omalizumab), which picked up FDA approval as a treatment for CSU in 2014. Xolair binds to immunoglobulin E in the blood, preventing it from triggering allergic reactions. In 2024, the injectable anti-inflammatory antibody netted about $1.6 billion in sales.
Sanofi and Regeneron have worked for years to challenge Xolair’s CSU dominance with Dupixent (dupilumab). With Xolair's compound patent already expired and its formulation patent set to expire in November 2025, Novartis has been hard at work seeking a successor to the blockbuster drug.
In August 2023, Novartis announced that oral BTK inhibitor remibrutinib improved symptom severity in patients with CSU in a pair of phase 3 trials. Later, the company said it planned to submit the antibody for approval sometime in 2025 (PDF).
Potential Xolair competitors are also looming in biotech. For example, Third Harmonic Bio is going all in on its CSU asset, with plans to bring the KIT inhibitor into a phase 2 trial by the middle of 2025.
Lately, Novartis has been looking externally for preclinical prospects. The Swiss giant signed a potential $1 billion deal last month with newly emerged Light Horse Therapeutics to pursue multiple hard-to-drug cancer targets.
And, at the end of last year, BioAge Labs inked a pact with Novartis worth up to $550 million to discover multiple therapeutic targets in age-related diseases.