• 17 Jul 2025
• Admin
• News Article

Boehringer Ingelheim & LEO Pharma partner to commercialize and further develop Spevigo

Overview

Boehringer Ingelheim, a biopharmaceutical company active in both human and animal health, and LEO Pharma, a global leader in medical dermatology, announced an exclusive global license and transfer agreement to commercialize and advance the development of Spevigo (spesolimab).

About the monoclonal antibody: Spevigo

• 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). 
• 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.
• 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.

Terms of the agreement

• 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. 

Statement from Shashank Deshpande: Chairman, Boehringer Ingelheim

“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.”

Statement from Christophe Bourdon: CEO, LEO Pharma

“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.” 

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, 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.

Spevigo: Availability across globe

• Spevigo is available in more than 40 countries including the US, Japan, China, and most European countries to treat GPP flares in adults. 
• 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. 
• Additionally, Spevigo has also been approved for expanded indications in generalized pustular psoriasis in the EU, US and China. 
• Spevigo is also under investigation for the treatment of other IL-36 mediated skin diseases.

Transaction completion- 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.

GPP: A Distinct, Life-Threatening Inflammatory Disease with Unpredictable Burden

• 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. 
• 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. 
• 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.

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. 

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. It delivers innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare.