Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO ® (spesolimab)
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). 123 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.
July, 2025
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. 78 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. 89 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. 81011
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 www.boehringer-ingelheim.com.
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 serve 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.
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
14 minutes ago
- Business Wire
Children's of Alabama and University of Alabama at Birmingham Study Shows Association with a 30% Reduction in Mechanical Ventilation Using Etiometry's Clinical Intelligence Platform
BOSTON--(BUSINESS WIRE)--A newly published study in the Journal of Pediatric Critical Care (JPCC) has demonstrated that integrating Etiometry's Clinical Intelligence Platform at the Children's Hospital of Alabama observed association with significantly improved patient outcomes in the pediatric cardiac intensive care unit (ICU). The study observed a 30% reduction in mechanical ventilation duration and a 20% decrease in overall hospital length of stay for post-surgical patients. These improved patient outcomes benefits translate to freeing up ICU resources and ultimately, cost savings for hospitals. The research, titled Automated Spontaneous Breathing Trial Performance Tool is Associated with Improved Outcomes Following Pediatric Cardiac Surgery: A Single-Center Retrospective Study from Alabama, USA, evaluated the implementation of an automated spontaneous breathing trial (SBT) performance tool from Etiometry's Clinical Intelligence Platform. This innovative approach leverages near real-time clinical and ventilator data to automate the hospital's Extubation Readiness Test (ERT) practices, driving more timely initiation and more consistent adherence to the practices. This results in both reduced time on mechanical ventilation and length of hospital stay. The study's findings indicate that the deployment of Etiometry's SBT tool was associated with a significant reduction in postoperative total ventilation time (TOV) and length of stay (LOS). Specifically, the incidence rate for postoperative TOV was 0.7 times lower post-implementation (P < 0.0001), and the postoperative LOS was reduced by 20% (0.81 times, P < 0.01). The single-center study's significant dataset of 787 pediatric patients makes the findings highly relevant for this patient population. 'The observed reduction in the duration of mechanical ventilation in this study may be clinically meaningful,' said Dr. Santiago Borasino, medical director of the cardiovascular intensive care unit at Children's of Alabama professor at the University of Alabama at Birmingham, and the study's principal investigator. 'When we are able to reduce a patient's time on mechanical ventilation, we are also decreasing their risk of complications such as pneumonia and potentially helping them recover faster and shorten their stay in the ICU. These improved patient outcomes benefits translate to freeing up ICU resources and ultimately, cost savings for hospitals. ' The results of this study highlight the impact of integrating automated clinical intelligence tools into ICU workflows. By enabling proactive decision-making, Etiometry's platform empowers care teams to optimize mechanical ventilation strategies, reducing hospital stays and improving patient outcomes. To access the full study, visit: About Children's of Alabama Since 1911, Children's of Alabama has provided specialized medical care for ill and injured children, offering inpatient, outpatient and primary care throughout Central Alabama. Ranked among the best children's hospitals in the nation by U.S. News & World Report, Children's serves patients from every county in Alabama and nearly every state. Children's is a private, not-for-profit medical center that serves as the teaching hospital for the University of Alabama at Birmingham (UAB) pediatric medicine, surgery, psychiatry, research and residency programs. The medical staff consists of UAB faculty and Children's full-time physicians, as well as private practicing community physicians. About Etiometry Founded in 2010, Etiometry is a leader in clinical decision-support software designed to help clinicians in intensive care units make data-driven, proactive decisions. By leveraging advanced analytics and AI-powered insights, the company empowers care teams to detect subtle changes in patient conditions, prevent complications, and improve recovery times. Etiometry has received ten FDA clearances and is trusted by leading healthcare institutions worldwide, including top-ranked academic medical centers and pediatric hospitals. The company is committed to advancing patient safety, improving clinical efficiency, and lowering the cost of care through smarter data utilization. Etiometry's risk analytics support clinician review of physiologic trends and may aid in awareness of patient trajectory. The platform does not diagnose or treat. To learn more, visit
Business Wire
14 minutes ago
- Business Wire
Calero Launches New Offering to Meet Organizations' Most Critical SaaS Management Needs – Visibility, Control, and Optimization
ROCHESTER, N.Y.--(BUSINESS WIRE)-- Calero, the leading provider of Technology Business Management solutions, today announced a new SaaS Management offering designed to meet the urgent needs of today's organizations. The simplified offering will quickly and cost-effectively add value to overworked and under-resourced IT teams by providing solutions for visibility, control and optimization. The Calero SaaS Management Platform (SMP) offering meets users where they are today – not overwhelming them with more work. Now more than ever, organizations rely on a wide array of software-as-a-service (SaaS) tools to manage day-to-day operations. While many of these applications are effectively centralized, an increasing number of SaaS applications are brought into the business by end users without the knowledge of IT or Procurement. This shadow SaaS can create data silos, redundancies, waste, and risk. The Calero SaaS Management Platform (SMP) offering meets users where they are today – not overwhelming them with more work. Whether organizations need visibility, control, or optimization, the Calero SMP offering provides a proven, cost-effective solution from a company with staying power and a three-decade history of success. Calero's Visibility offering provides immediate insight into the SaaS applications and usage in the organization. Using existing data sources, IT leaders can identify unapproved and risky apps and organize their environment, leading to exceptional time-to-value at a very low cost. Calero's Control offering provides organizations real-time, actionable recommendations for their most critical SaaS Vendors. The solution leverages discovery sources, finance systems, and vendor data for one source of truth, so teams can improve license usage efficiency, negotiate renewals with confidence, and drive accountability. And Calero's Optimization offering empowers teams to meet more strategic goals without adding headcount. This solution leverages Calero's managed services expertise to reclaim valuable time fetching vendor data, managing licenses for joiners, leavers, and movers, preparing for renewals, and more. Results include better user experiences and more efficient SaaS spend. "Many leaders recognize they have a significant SaaS management problem but are unsure where to start," said Scott Gilbert, CEO of Calero. "Inaction comes at a cost. With over 30 years' experience helping organizations manage telecommunications, mobility, and market data, Calero makes it easier for leaders to address these challenges. We're committed to lowering barriers to entry and leading the way again." For more information on Calero's new SaaS Management offering, technology leaders from CIOs to IT managers can visit About Calero Calero is the leading provider of Technology Business Management solutions, empowering organizations to streamline and optimize their technology investments through three key solution pillars: Technology Expense Management: Advanced software solutions designed to optimize technology spend across market data, telecom, mobile, SaaS, and beyond. Technology Lifecycle Management: Comprehensive unified platform that enhances IT asset management, providing detailed inventory visibility, lifecycle tracking, and secure processes for asset reallocation and disposal—from procurement to retirement. Managed Technology Services: Tailored managed services that enable organizations to automate, streamline, and maximize the efficiency of IT resource management. With a focus on delivering actionable insights and operational efficiency, Calero helps businesses achieve greater control and cost savings across their technology ecosystem. Find out more at
Business Wire
14 minutes ago
- Business Wire
Zydus Announces Completion of the Acquisition of an 85.6% Stake in Amplitude Surgical and Upcoming Filing of a Simplified Tender Offer
AHMEDABAD, India & VALENCE, France--(BUSINESS WIRE)--Regulatory News: Zydus Lifesciences Limited 1 (' Zydus '), on March 11, 2025, entered into agreements with PAI and two minority shareholders of Amplitude Surgical (Paris:AMPLI) to acquire blocks of shares representing in aggregate 85.6% of Amplitude Surgical's share capital and voting rights 2 at a price of €6.25 per share and a total consideration of €256.8mn (the ' Block Acquisition '). As all conditions precedent to the completion have now been fulfilled, and the Block Acquisition has been subsequently completed on July 29, 2025, Zydus now holds 85.6% of the share capital and voting rights of Amplitude Surgical. Olivier Jallabert will remain in his role as CEO of Amplitude Surgical, and, as part of the Block Acquisition, has invested into the company which has completed the Block Acquisition. In the context of the Block Acquisition, Amplitude Surgical has terminated with effect as of July 28, 2025 its liquidity contract entered into between Amplitude Surgical, Oddo BHF and Natixis dated June 19, 2018. Zydus will file a simplified mandatory tender offer (the ' Offer ') on July 30, 2025 for all the remaining outstanding shares of Amplitude Surgical at a price of €6.25 per share, at par with the price paid for the Block Acquisition. Considering the certain undertakings to tender received from seven shareholders representing in aggregate 4.7% of share capital and voting rights 3, Zydus will be able to secure more than 90% of the capital and voting rights of Amplitude Surgical upon completion of the Offer and will subsequently request the implementation of a squeeze-out. Subject to the French Financial Market Authority's (Autorité des marches financiers, AMF) clearance of the Offer, it is currently envisaged that the Offer may be opened in September 2025. No other regulatory approval will be required. On July 28, 2025, the Board of Directors of Amplitude Surgical unanimously welcomed the Offer and on the same date issued its reasoned opinion following receipt of the fairness opinion from Finexsi, appointed as independent expert for the purpose of the Offer. ***** About Zydus Lifesciences Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit ***** About Amplitude Surgical Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player in the global market for surgical technologies for lower limb orthopaedics. Amplitude Surgical develops and markets high-end products for orthopaedic surgery, covering the main pathologies affecting the hip and knee. Working in close collaboration with surgeons, Amplitude Surgical develops numerous high value-added innovations to best meet the needs of patients, surgeons and care facilities. A leading player in France, Amplitude Surgical is expanding internationally through its subsidiaries and a network of agents and exclusive distributors in over 30 countries. As of June 30, 2025, Amplitude Surgical employed 429 people and generated revenue of nearly €111 million. ******* This press release must not be published, broadcast or distributed, directly or indirectly, in any countries in which the distribution of this information is subject to legal restrictions. Therefore, persons in countries where this press release is disseminated, published or distributed should inform themselves about and comply with any such restrictions. This release contains forward-looking statements that are based on assessments or assumptions that were reasonable at the date of the release, and which may change or be altered due, in particular, to random events or uncertainties and risks relating to the economic, financial , regulatory and competitive environment, the risks set out in the 2023/2024 Universal Registration Document, and any risks that are unknown or non-material to date that may subsequently occur. The Company undertakes to publish or disclose any adjustments or updates to this information as part of the periodic and permanent information obligation to which all listed companies are subject. This press release contains inside information within the meaning of Regulation No. 596/2014 of 16 April 2014 on market abuse. 1 Through its subsidiaries/affiliates 2 Directly and indirectly through the acquisition of holding companies Auroralux, Ampliman 1 and Ampliman 2, and excluding treasury shares held by assimilation and on the basis of a total number of shares and theoretical voting rights of 48,020,841 3 Press release of April 17, 2025
