Licensee: Johnson & Johnson (Janssen)
Deal size: $1.35 billion
Upfront: $750 million
Asset: interleukin-1 alpha inhibitor bermekimab
Johnson & Johnson’s Janssen Pharma unit swooped on a midstage immunology asset developed by Xbiotech as 2019 drew to a close, paying a hefty $750 million for global rights to interleukin-1 alpha (IL-1α) inhibitor bermekimab as a treatment for inflammatory skin diseases.
Another $600 million is on the table if Janssen decides to pursue development of the drug outside of the dermatology category, and Xbiotech will also get payments for completing two ongoing phase 2 trials of the drug in atopic dermatitis and chronic immune-mediated skin disease hidradenitis suppurativa (HS), as well as manufacturing.
It was a sizable upfront fee for access to a drug that still hasn’t completed proof-of-principle testing at scale, with data in atopic dermatitis and HS not due until the third quarter of this year.
The deal is a big bounce back for Texas-based Xbiotech after bermekimab (formerly known as MABp1) was rejected by European regulators in 2017 as a treatment for symptoms of colorectal cancer—such as muscle wasting (cachexia)—under the Xilonix brand name.
The EMA concluded that the drug failed to show clear improvements in either lean body mass or quality of life, and patients also seemed to have a higher risk of developing infections. Since then, however, readouts in inflammatory diseases have reinvigorated the drug, which according to J&J is the only IL-1a inhibitor in clinical development.
Xbiotech is still exploring use of the drug in oncology, notably in pancreatic, lung and ovarian cancer, and also thinks it could have potential tackling inflammation in diseases such as heart disease, stroke, arthritis and inflammatory bowel disease.
Xbiotech is hoping for big things from its drug in atopic dermatitis, even though the category has seen a flurry of new therapies reach the market and is becoming increasingly competitive.
In its favor is phase 2 data reported last year which suggested that the IL-1a antagonist might be more effective than Sanofi and Regeneron’s fast-growing IL-4 inhibitor Dupixent (dupilumab), the first biologic drug to be approved for atopic dermatitis in 2017.
Bermekimab achieved a 75% reduction in symptoms like itching and pain in 71% of treated patients within seven weeks—a top-line result that seems to outperform Dupixent, although there hasn’t been a head-to-head trial of the two drugs and the readout only included data from 38 patients.
Meanwhile, an intravenous formulation of Xbiotech’s drug was more effective at reducing pain than placebo in HS patients who had failed treatment with AbbVie’s blockbuster TNF inhibitor Humira (adalimumab), which has been approved for the disease since 2015.