LEO Pharma a leading global company in medical dermatology
LEO Pharma, a leading global company in medical dermatology, has successfully finalized its acquisition of Spevigo® from Boehringer Ingelheim, as officially announced on July 14, 2025. The transaction was completed following approval from all relevant regulatory authorities. The key terms of the deal and the financial assumptions previously outlined in LEO Pharma’s initial announcement remain unchanged. Moving forward, LEO Pharma and Boehringer Ingelheim will continue collaborating closely to ensure a seamless transition of Spevigo® into LEO Pharma’s portfolio.
Spevigo® is a groundbreaking therapy and represents a significant advance in dermatology. It is a humanized, selective monoclonal antibody that targets and inhibits the interleukin-36 (IL-36) receptor, a central signaling pathway in the immune system. This pathway has been identified as playing a critical role in the pathogenesis of several autoinflammatory disorders, most notably generalized pustular psoriasis (GPP). The therapy’s mechanism of action specifically blocks IL-36 receptor activation, thereby modulating immune responses that drive disease symptoms.
As part of LEO Pharma’s global dermatology portfolio, Spevigo® will serve as the company’s third strategic brand. The medicine is currently approved and available in over 40 countries, including key markets such as the United States, Japan, China, and most European nations. Spevigo® is indicated for the treatment of GPP flares in adults, addressing a condition with limited therapeutic options and high unmet medical need.
Christophe Bourdon, CEO of LEO Pharma, emphasized the strategic importance of this acquisition, stating, “With our expertise in dermatology, LEO Pharma is uniquely positioned to take over Spevigo® and expand access to care, bringing meaningful progress to underserved patients. We are committed to ensuring that this innovative treatment reaches its full potential by building on the pioneering efforts of Boehringer Ingelheim. Expanding patient access to Spevigo® is a critical step in supporting individuals living with GPP, a community that currently faces limited treatment alternatives.”
Understanding Generalized Pustular Psoriasis (GPP)
GPP is a rare, heterogeneous, and potentially life-threatening skin disease. It is characterized by the accumulation of neutrophils, a type of white blood cell, in the skin, which leads to the formation of painful, sterile pustules. These pustules can appear across large areas of the body, often accompanied by systemic symptoms such as fever, malaise, fatigue, and, in severe cases, organ dysfunction. The course of GPP varies significantly between patients. Some individuals experience relapsing episodes, with recurrent flares that can be acute and debilitating, while others have a more persistent disease pattern with intermittent flares. This variability underscores the urgent need for targeted therapies that can address both the acute and chronic manifestations of the condition.
The approval of Spevigo® provides a mechanism-driven treatment option, offering hope for patients who previously had few alternatives to manage GPP flares effectively. By blocking IL-36 receptor activation, Spevigo® directly targets the underlying inflammatory pathways responsible for pustule formation and systemic inflammation, potentially reducing the frequency and severity of flares.
LEO Pharma’s Strategy for Spevigo®
Following the acquisition, LEO Pharma will assume full responsibility for the commercialization and ongoing development of Spevigo®. The company will leverage its extensive global commercial platform in medical dermatology to accelerate and expand access to this therapy for patients living with GPP. Additionally, LEO Pharma is exploring the potential of Spevigo® for other IL-36-mediated skin diseases, such as pyoderma gangrenosum, a rare neutrophilic dermatosis characterized by painful ulcerative lesions. By investigating Spevigo® in these additional indications, LEO Pharma aims to broaden the therapeutic impact of this innovative treatment beyond GPP.
Financial Considerations and Outlook
Spevigo® will be included in LEO Pharma’s financial reporting for the fiscal year 2025, with three months of impact anticipated. Preliminary internal assessments indicate that the therapy is expected to contribute less than one percent to overall revenue growth in 2025. The ongoing costs associated with Spevigo®, primarily related to development activities, are projected to reduce the adjusted EBITDA margin by up to two percentage points for the year. Importantly, excluding the impact of Spevigo®, LEO Pharma’s previously communicated financial outlook remains unchanged. The company continues to anticipate revenue growth of 7–9% at constant exchange rates, along with an adjusted EBITDA margin of 16–18%, as outlined in its H1 2025 Interim Report published on August 18, 2025.
Expanding Access and Impact
The acquisition of Spevigo® aligns with LEO Pharma’s strategic commitment to addressing unmet needs in dermatology. By integrating Spevigo® into its global portfolio, the company aims to enhance patient access and deliver high-quality care to individuals with complex skin diseases. GPP, while rare, represents a critical area of focus due to the severity of symptoms and lack of comprehensive treatment options. LEO Pharma’s experience in managing global dermatology brands positions it to optimize distribution, support healthcare professionals, and drive awareness among patients and medical communities.
Christophe Bourdon added, “This acquisition exemplifies our dedication to innovation and patient-centric care. By expanding the reach of Spevigo®, we are not only providing a much-needed treatment option but also reinforcing our commitment to improving outcomes for patients with rare and challenging dermatological conditions. Our goal is to ensure that every patient who can benefit from Spevigo® has timely access to this therapy.”
Beyond immediate commercialization, LEO Pharma is committed to the continued development and exploration of Spevigo®’s potential. Clinical programs are underway to assess its efficacy and safety in additional IL-36-driven skin disorders. This ongoing research underscores LEO Pharma’s long-term commitment to advancing dermatology innovation and addressing diseases with limited therapeutic options.
The partnership between LEO Pharma and Boehringer Ingelheim during this transition phase will ensure continuity in patient care, maintaining supply, support services, and clinical guidance. Both companies share a commitment to responsible stewardship of Spevigo®, ensuring that the therapy’s launch in new markets and expanded patient access is executed with the highest standards of safety and efficacy.
