The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.
Thornhill, Ontario, Canada - October 31, 2020: LEO Pharma Canada sign outside their head office building in Thornhill, Ontario, Canada. LEO Pharma AS is a multinational Danish pharmaceutical company | Image Credit: © JHVEPhoto - stock.adobe.com.
LEO Pharma has entered into a global licensing and transfer agreement with Boehringer Ingelheim for the commercialization and continued development of spesolimab, marketed as Spevigo (1). The monoclonal antibody (mAb) is the first targeted treatment approved for flares of generalized pustular psoriasis (GPP), a rare and potentially life-threatening inflammatory skin condition.
The agreement places LEO Pharma at the helm of Spevigo’s next phase, building on its presence in more than 40 countries—including the United States, Japan, China, and across Europe—where it is approved for the treatment of GPP flares in adults. Regulatory authorizations have also been granted for broader GPP indications in the US, European Union, and China (2).
·LEO Pharma will lead global commercialization and development of Spevigo, expanding its role in rare dermatology drug manufacturing and access.
·The IL-36-targeting monoclonal antibody is advancing beyond GPP, with new development efforts focused on other rare autoinflammatory skin diseases.
·The agreement includes milestones and royalties, highlighting strategic deal-making trends in pharma for rare disease therapies with high unmet need.
Spesolimab is a humanized, selective mAb that blocks activation of the interleukin-36 (IL-36) receptor, a signaling pathway central to the development of several autoinflammatory skin diseases (3–5). In GPP, the IL-36 pathway is considered a critical driver of disease activity, making it a key target for therapeutic intervention.
GPP is a severe and unpredictable condition characterized by widespread sterile pustules, skin inflammation, and systemic symptoms such as fever, fatigue, and in some cases, organ failure (6–10). Patients may experience relapsing or persistent disease with varying intensity, and quality of life is often significantly impaired. Clinical studies show GPP is distinct from plaque psoriasis, with unique underlying pathology and treatment needs (6,7).
Spevigo has been evaluated in the largest clinical development program dedicated to GPP to date (1). It remains the only treatment for GPP flares that specifically targets IL-36 and has been validated in a randomized, placebo-controlled trial. Further investigation is underway to assess its potential in other IL-36-mediated dermatologic diseases with limited treatment options.
Under the agreement, LEO Pharma assumes responsibility for both global commercialization and further clinical development of the drug (1). The company plans to leverage its existing medical dermatology infrastructure to increase awareness and patient access to the treatment.
“Partnering to bring Spevigo to more patients is more than a strategic step—it means the opportunity to help people living with GPP by addressing a disease with limited treatment options and aiming to improve their quality of life,” said Christophe Bourdon, CEO of LEO Pharma (1). “We are inspired by Boehringer Ingelheim’s pioneering efforts and thrilled to build on that foundation.”
The deal is expected to close in the second half of 2025, pending regulatory clearance (1). Boehringer Ingelheim will receive an upfront payment of EUR 90 million, in addition to potential milestone payments and tiered royalties based on commercial performance.
Boehringer Ingelheim’s initial development of Spevigo marked a significant milestone for GPP patients and medical dermatology (1).
“We are immensely proud of what Spevigo represents for people living with GPP and bringing innovation to this community of patients has been a powerful reflection of our purpose to transform lives,” said Shashank Deshpande, chairman of the Board of Managing Directors and head of Human Pharma at Boehringer Ingelheim (1). “Spevigo holds a significant promise, and ensuring it reaches its full potential requires continued focus, and expertise in medical dermatology. With over six decades of singular dedication to this field, LEO Pharma is exceptionally well-positioned to build on the strong foundation we’ve laid.”
GPP remains a highly complex and underserved condition (1). Mortality rates for severe cases can range from 2% to 16%, often due to complications like multisystem organ failure and sepsis. Many patients also experience comorbidities that increase both personal and healthcare system burdens.
References
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