Boehringer Ingelheim and LEO Pharma enter partnership to commercialize and further develop SPEVIGO® (spesolimab)

Ingelheim, Germany & Ballerup, Denmark, July 14, 2025 – Boehringer Ingelheim and LEO Pharma today announced an exclusive global license and transfer agreement to commercialize and advance the development of SPEVIGO^® (spesolimab).

SPEVIGO^® is an innovative, humanized, and selective monoclonal antibody that targets and blocks the activation of the interleukin-36 (IL-36) receptor - a key signaling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases, including generalized pustular psoriasis (GPP).[1][2][3] This partnership extends beyond GPP, with an opportunity to investigate the potential of spesolimab in additional skin conditions with high unmet medical need in which IL-36 is implicated.

Under the terms of the agreement, LEO Pharma will be responsible for commercialization and further development of SPEVIGO® leveraging its global commercial platform within medical dermatology to raise disease awareness and secure access for patients with GPP. The addition of Boehringer Ingelheim’s flagship dermatology product, SPEVIGO^®, for the treatment of GPP, complements LEO Pharma’s existing strategic dermatology portfolio and reinforces its long-standing commitment to delivering transformational medicines to patients.

“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. “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. We remain profoundly grateful to the patients, caregivers, and healthcare professionals who have walked this journey with us.”

“Skin diseases can profoundly impact people’s lives - and at LEO Pharma, we are here to change that,” said Christophe Bourdon, CEO of LEO Pharma. “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. We are inspired by Boehringer Ingelheim’s pioneering efforts and thrilled to build on that foundation. Together, we have a powerful opportunity to expand access to innovative care and deliver meaningful progress for patients who have long been underserved.”

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.^7891011

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] It is the first approved treatment for GPP flares that specifically targets the IL-36 pathway and that has been evaluated in a statistically powered, randomized, placebo-controlled trial.[5] Additionally, SPEVIGO® has also been approved for expanded indications in generalized pustular psoriasis in the EU, U.S. and China.[6] SPEVIGO^® is also under investigation for the treatment of other IL-36 mediated skin diseases.

The transaction is anticipated to close in the second half of 2025, subject to merger control clearance, with Boehringer Ingelheim set to receive EUR 90 million as upfront payment, along with milestone payments and tiered royalties.

About SPEVIGO®

SPEVIGO® is a novel, 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.¹²³

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.[7][8] 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.⁸[9] 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[10][11]

[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] Boehringer Ingelheim. Spesolimab prevented generalized pustular psoriasis flares in Effisayil™ 2 trial. 2023. https://www.boehringer-ingelheim.com/human-health/skin-and-inflammatory-diseases/gpp/spesolimab-prevents-gpp-flares (Accessed 22 July 2024).

[6] Boehringer Ingelheim. European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis. 2024. https://www.boehringer-ingelheim.com/human-health/european-commission-approves-spevigo-new-and-expanded-indications-generalized-pustular-psoriasis (Accessed 29 June 2025).

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

[8] 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.

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

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

[11] 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.