Johnson & Johnson Partners with XBiotech in $750M Deal to Advance Bermekimab for Dermatological Indications

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Johnson & Johnson Reaches $750 Million Agreement with XBiotech for Global Rights to IL-1α Antibody Bermekimab in Dermatology IndicationsRecently, Johnson & Johnson entered into a collaboration agreement with XBiotech for $750 million, securing global rights to XBiotech’s IL-1α antibody, bermekimab, for dermatological indications. Under the terms of the agreement, Johnson & Johnson will be responsible for conducting Phase II clinical studies of bermekimab for the treatment of atopic dermatitis and hidradenitis suppurativa. Should Johnson & Johnson pursue the development of bermekimab for indications beyond dermatology, additional payments to XBiotech will be required. Notably, as of December 6, XBiotech’s market capitalization stood at only $457 million. Johnson & Johnson’s acquisition price for the global rights to bermekimab in dermatological indications exceeded XBiotech’s market cap by $293 million, underscoring the significant therapeutic potential of bermekimab in treating dermatological conditions.

XBiotech is a clinical-stage biopharmaceutical company engaged in the discovery and development of True Human monoclonal antibodies for the treatment of various diseases, with bermekimab as its core asset. Bermekimab (marketed as Xilonix) is a monoclonal antibody that specifically targets and neutralizes interleukin-1 alpha (IL-1α). Derived from XBiotech’s “True Human Antibody” fully human antibody screening platform, it binds to and neutralizes soluble or membrane-bound, full-length or fragmented IL-1α, but does not bind to IL-1β. IL-1α can promote angiogenesis, tumor growth and metastasis, as well as indirect symptoms associated with advanced cancer, such as metabolic dysregulation, fatigue, and anxiety.

Bermekimab is expected to be developed in the future.For the treatment of various tumors (colorectal cancer, non-small cell lung cancer, pancreatic cancer), multiple skin conditions (psoriasis, hidradenitis suppurativa, atopic dermatitis, acne, scleroderma), as well as peripheral vascular diseases and type 2 diabetes., with clinical studies for the treatment of colorectal cancer having entered Phase 3. However, the collaboration agreement signed between Johnson & Johnson and XBiotech this time is for the development of Bermekimab for dermatological indications.

In the treatment of atopic dermatitis, the first exploratory Phase 2 clinical trial of Bermekimab has been completed. The study data showed that Bermekimab achieved a significantly higher EASI-75 response rate (EASI-75 is an efficacy endpoint where EASI stands for Eczema Area and Severity Index, and EASI-75 indicates a 75% improvement from baseline) compared to Lebrikizumab and Dupixent. However, the proportion of patients achieving IGA 0/1, a commonly used primary clinical endpoint, was substantially lower than that observed with Lebrikizumab and Dupixent. Nevertheless, as this Phase 2a trial of Bermekimab employed an open-label design, whereas the trials for Lebrikizumab and Dupixent utilized randomized, double-blind, placebo-controlled designs, the reliability of Bermekimab’s clinical results requires further confirmation. In the treatment of hidradenitis suppurativa, Phase 2 clinical data for Bermekimab monotherapy demonstrated that after 12 weeks of treatment, 61–63% of patients achieved a HiSCR response (Hidradenitis Suppurativa Clinical Response, a measure of acceptable disease severity in HS), and 67–72% of patients attained clinically meaningful pain reduction.

Why Does Johnson & Johnson Place Such High Value on the Dermatological Indications of Bermekimab, Particularly Atopic Dermatitis and Hidradenitis Suppurativa (HS)?Johnson & Johnson’s strong interest in bermekimab for dermatological indications, especially atopic dermatitis and hidradenitis suppurativa (HS), stems not only from the large patient population, substantial market demand, and urgent need for new and effective therapies in this field, but also from the relatively limited number of innovative therapies approved in recent years. In the area of atopic dermatitis, newly approved treatments in recent years include Sanofi/Regeneron’s Dupixent and Pfizer’s Eucrisa. Notably, Dupixent achieved annual sales exceeding €1 billion in its third year on the market, becoming a blockbuster drug. Meanwhile, in the HS treatment landscape, Humira remains the only biologic agent currently approved by the U.S. Food and Drug Administration (FDA), highlighting an urgent need for new and effective therapeutic options.

Dupixent (dupilumab) is a fully human monoclonal antibody that specifically inhibits IL-4 and IL-13. It was first approved in 2017 for the treatment of moderate-to-severe atopic dermatitis (AD) and has since received approval for three indications: AD, asthma, and chronic rhinosinusitis. Since its launch, Dupixent’s annual sales have surged rapidly, reaching €219 million in 2017 and €788 million in 2018. In the first three quarters of this year alone, sales exceeded €1 billion, totaling €1.377 billion, with the majority attributable to the atopic dermatitis indication. EvaluatePharma previously projected that Dupixent’s sales would reach $5.1 billion by 2024, positioning it as the top-selling therapy for atopic dermatitis. In addition to Dupixent, several other interleukin-targeting monoclonal antibodies are currently in development, including ANB020 (an anti-IL-33 monoclonal antibody developed by AnaptysBio), lebrikizumab (an anti-IL-13 agent acquired by Dermira from Roche Genentech), and MOR106 (an anti-IL-17C monoclonal antibody developed by Novartis/Galapagos/MorphoSys). These agents are expected to receive regulatory approval and enter the market in the coming years.

Facing such a formidable competitor as Dupixent, Johnson & Johnson cannot be overly optimistic. After all, the weekly injection frequency of bermekimab results in lower patient adherence compared with Dupixent (administered every two weeks) and lebrikizumab (administered every four weeks). It is anticipated that bermekimab will have to rely on its efficacy and pricing advantages to compete with other therapies in the future. In the treatment of hidradenitis suppurativa (HS), bermekimab outperforms Humira, as it demonstrates efficacy in patients regardless of prior Humira exposure. Moreover, bermekimab monotherapy can substantially alleviate pain, whereas Humira requires combination with antibiotics to achieve pain reduction. Looking ahead, bermekimab is expected to reshape the current therapeutic landscape for HS.

References:

[1] Johnson & Johnson, XBiotech, and Dermira official websites

[2] Top novel atopic dermatitis therapies in 2024

Original Title: Collaboration | Johnson & Johnson Partners with XBiotech in $750 Million Deal to Expand Dermatology Indications for Bermekimab