Boehringer Ingelheim and LEO Pharma Join Forces to Globalize SPEVIGO® Treatment for Generalized Pustular Psoriasis (GPP)

Boehringer Ingelheim and LEO Pharma Join Forces to Globalize SPEVIGO® Treatment for Generalized Pustular Psoriasis (GPP)

(IN BRIEF) Boehringer Ingelheim and LEO Pharma have agreed on a global license and transfer deal for SPEVIGO® (spesolimab), an antibody that blocks the IL‑36 receptor to treat generalized pustular psoriasis (GPP). LEO Pharma will assume worldwide commercialization and clinical development, harnessing its extensive dermatology network to expand patient access. Boehringer Ingelheim will receive EUR 90 million upfront, plus milestones and royalties, upon deal completion in H2 2025. SPEVIGO®—approved in over 40 countries and evaluated in large randomized trials—is the first targeted therapy for GPP flares. The collaboration also opens the door to investigating SPEVIGO® in other IL‑36‑driven skin conditions.

(PRESS RELEASE) INGELHEIM/BALLERUP, 15-Jul-2025 — /EuropaWire/ — Boehringer Ingelheim and LEO Pharma have entered into an exclusive global licensing and transfer agreement to expand the reach and development of SPEVIGO® (spesolimab), their innovative treatment for generalized pustular psoriasis (GPP). By combining LEO Pharma’s six decades of dermatology expertise with Boehringer Ingelheim’s proven track record in delivering SPEVIGO® to more than 40 countries, the partnership aims to streamline patient access and ensure uninterrupted support for those living with this rare and severe skin disease. Both companies will work hand‑in‑hand to transition all commercial and operational activities smoothly.

SPEVIGO® is a humanized monoclonal antibody that selectively inhibits the interleukin‑36 receptor, a key driver of autoinflammatory conditions such as GPP. Under this agreement, LEO Pharma will take the lead on global commercialization and further clinical development, leveraging its deep experience in medical dermatology to raise awareness of GPP and secure access for patients worldwide. This addition to LEO Pharma’s strategic portfolio underscores its commitment to delivering transformative therapies for underserved skin conditions.

Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, commented, “SPEVIGO® represents a milestone for people affected by GPP. To fulfil its promise, we need focused expertise in dermatology—expertise that LEO Pharma has demonstrated over six decades. We are deeply thankful to the patients, caregivers, and healthcare professionals who have supported this journey.”

Christophe Bourdon, CEO of LEO Pharma, added, “GPP can devastate lives, and this partnership is more than strategic—it’s an opportunity to improve quality of life for patients with limited treatment options. We are honoured to build on Boehringer Ingelheim’s pioneering work and bring SPEVIGO® to more people in need.”

GPP is characterized by widespread, sterile pustules driven by neutrophil accumulation, and can present with life‑threatening systemic symptoms such as fever, malaise, and risk of organ failure. SPEVIGO® is the first therapy targeting the IL‑36 pathway to receive approval for GPP flares, backed by robust randomized, placebo‑controlled trials, and is authorized in key markets including the U.S., EU, China, and Japan. Its potential is also being explored in other IL‑36‑mediated skin disorders.

The deal, expected to close in the second half of 2025 pending regulatory clearance, includes an upfront payment of EUR 90 million to Boehringer Ingelheim, along with milestone-based 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.2,3,4.

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.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.9,10,11.

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

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 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.

Media Contacts:

Boehringer Ingelheim

Tereza Urbankova
Senior Media Relations Manager
E-Mail: press@boehringer-ingelheim.com
Phone Number: +49 (6132) 77-184817

LEO Pharma

Jeppe Ilkjær
Media
E-Mail: jeilk@leo-pharma.com
Phone Number: +45 3050 2014

Christian Soerup Ryom
Investors
E-Mail: chsoe@leo-pharma.com
Phone Number: +45 3089 9083

SOURCE: Boehringer Ingelheim