LEO Pharma closes deal for Spevigo®

BALLERUP, Denmark, October 1, 2025 – LEO Pharma, a global leader in medical dermatology, has successfully closed the deal for Spevigo® with Boehringer Ingelheim, as announced on July 14, 2025, following approval from all relevant authorities. The terms of the transaction and the financial assumptions outlined in LEO Pharma’s initial press release regarding the deal remain unchanged. LEO Pharma and Boehringer Ingelheim will continue working closely together on finalizing all aspects of the transition of Spevigo® to LEO Pharma.

Spevigo® is an innovative, humanized, and selective monoclonal antibody that targets and blocks the activation of the interleukin-36 (IL-36) receptor - a key signalling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases, including generalized pustular psoriasis (GPP). ^1,2,3

Spevigo® will join LEO Pharma’s global dermatology portfolio as its third strategic brand. Spevigo^® is available in more than 40 countries including the U.S., Japan, China, and most European countries to treat GPP flares in adults.⁴

“With our specialization in dermatology, LEO Pharma is uniquely positioned to take over Spevigo® and expand access to care, bringing progress to underserved patients,” said Christophe Bourdon, CEO of LEO Pharma. “We are committed to ensuring this innovative treatment reaches its full potential by building on Boehringer Ingelheim’s pioneering efforts. Bringing Spevigo® to more patients is an important step in helping those living with GPP, a community with limited treatment options.”

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, leading to painful, sterile pustules across the body. The disease course varies, with some patients experiencing relapsing episodes with recurrent flares - often accompanied by fever, malaise, fatigue, and a risk of organ failure - while others endure persistent disease with intermittent flares. ^7-11

LEO Pharma will be responsible for commercialization and further development of Spevigo®, leveraging its global commercial platform in medical dermatology to accelerate and expand access to treatment for patients with GPP. Spesolimab is also being investigated for the treatment of other IL-36-mediated skin diseases, including pyoderma gangrenosum.

Spevigo® will be included in the financials for FY 2025 with three months of impact. Preliminary assessment suggests that Spevigo® will contribute less than one percent to revenue growth in 2025. Ongoing costs for Spevigo®, mainly related to development activities, are preliminarily assessed to reduce the adjusted EBITDA margin in 2025 by up to two percentage points. Excluding Spevigo® the outlook for revenue growth of 7-9% at constant exchange rates and an adjusted EBITDA margin of 16-18%, as communicated with the H1 2025 Interim Report, published August 18, 2025, is unchanged.

-- LEO Pharma A/S --

About Spevigo®

Spevigo® is a humanized, selective antibody that specifically blocks the activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.^1,2,3

About generalized pustular psoriasis (GPP)

GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.^5,6 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. ^7,8 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.^8,9

References

[1] Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551.

[2] Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11:e043666.

[3] Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431–2440.

[4] Record on file.

[5] Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19.

[6] Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273.

[7] Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21–29.

[8] Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919.

[9] Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71.