Eli Lilly has staked a claim to the emerging market for BTK inhibitors via a $690m licensing deal with South Korean company Hanmi Pharmaceutical.
The US drug major is paying $50m upfront for rights to Hanmi’s HM71224, a BTK inhibitor that will shortly start phase II testing in multiple autoimmune disorders, including rheumatoid arthritis (RA) and lupus.
Under the terms of the deal Lilly has taken rights to the drug in all world markets – with the exception of China, Korea, Taiwan and Hong Kong – and Hanmi will earn double-digit royalties on Lilly sales.
The first BTK inhibitor to reach the market was Johnson & Johnson (J&J) and Pharmacyclics’ Imbruvica (ibrutinib), which has been introduced initially for blood cancers including chronic lymphocytic leukaemia (CLL) and is not in trials for autoimmune diseases.
Animal models of arthritis suggest that BTK inhibition can block B-cell receptor-dependent cell proliferation and reduce inflammatory cytokine production. In addition to RA and lupus, the class has potential in lupus nephritis, Sjögren’s syndrome and potentially even disorders such as asthma.
HM71224 has shown promising activity in preclinical studies and a phase I study in Europe, according to Gwan Sun Lee, Hanmi’s chief executive. During last year’s European League Against Rheumatism (EULAR) conference, the Korean firm presented interim data from an ongoing phase 1 study in 58 healthy volunteers recruited in Netherlands. According to the presentation, HM71224 dose-proportional absorption of the drug was observed in the volunteers – from both single dose and multiple doses – and this was not affected by food intake.
“We’re highly encouraged by the potential of HM71224 to deliver an innovative, first-in-class treatment option,” said Thomas Bumol, who heads Lilly’s biotechnology and immunology research operations.
Pharmacyclics has a BTK inhibitor in early development for rheumatoid arthritis, while other companies developing candidates for autoimmune diseases include Aegera Therapeutics, Principia Biopharma and Avila Therapeutics.