{"id":61574,"date":"2025-07-14T13:04:15","date_gmt":"2025-07-14T11:04:15","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/boehringer-ingelheim-and-leo-pharma-enter-partnership-to-commercialize-and-further-develop-spevigo-spesolimab\/"},"modified":"2025-07-14T13:04:15","modified_gmt":"2025-07-14T11:04:15","slug":"boehringer-ingelheim-and-leo-pharma-enter-partnership-to-commercialize-and-further-develop-spevigo-spesolimab","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/boehringer-ingelheim-and-leo-pharma-enter-partnership-to-commercialize-and-further-develop-spevigo-spesolimab\/","title":{"rendered":"Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO\u00ae (spesolimab)"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nPartnership will accelerate and broaden access to treatment for more patients with generalized pustular psoriasis (GPP), a rare and devastating skin condition<\/li>\n<li>\nLEO Pharma\u2019s six decades of dermatology expertise and Boehringer\u2019s global track record in bringing SPEVIGO<sup>\u00ae<\/sup> to over 40 countries will be combined to ensure continuous patient support<\/li>\n<li>\nBoehringer Ingelheim and LEO Pharma will closely cooperate to ensure a smooth transition of all operations<\/li>\n<\/ul>\n<p>INGELHEIM, Germany &amp; BALLERUP, Denmark&#8211;(BUSINESS WIRE)&#8211;<b>GLOBAL RELEASE &#8211; NOT INTENDED FOR UK MEDIA<\/b><\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250714349390\/en\/662919\/5\/leopharma.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250714349390\/en\/662919\/22\/leopharma.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250714349390\/en\/662919\/5\/leopharma.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250714349390\/en\/662919\/21\/leopharma.jpg\"><\/a><\/p>\n<p>\nBoehringer Ingelheim and LEO Pharma today announced an exclusive global license and transfer agreement to commercialize and advance the development of SPEVIGO<sup>\u00ae<\/sup> (spesolimab).<\/p>\n<p>\nSPEVIGO<sup>\u00ae<\/sup> is an innovative, humanized, and selective monoclonal antibody that targets and blocks the activation of the interleukin-36 (IL-36) receptor &#8211; a key signaling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases, including generalized pustular psoriasis (GPP).<sup>123<\/sup> 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.<\/p>\n<p>\nUnder the terms of the agreement, LEO Pharma will be responsible for commercialization and further development of SPEVIGO\u00ae leveraging its global commercial platform within medical dermatology to raise disease awareness and secure access for patients with GPP. The addition of Boehringer Ingelheim\u2019s flagship dermatology product, SPEVIGO<sup>\u00ae<\/sup>, for the treatment of GPP, complements LEO Pharma\u2019s existing strategic dermatology portfolio and reinforces its long-standing commitment to delivering transformational medicines to patients.<\/p>\n<p>\n\u201cWe are immensely proud of what SPEVIGO<sup>\u00ae <\/sup>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,\u201d said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. \u201cSPEVIGO<sup>\u00ae <\/sup>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\u2019ve laid. We remain profoundly grateful to the patients, caregivers, and healthcare professionals who have walked this journey with us.\u201d<\/p>\n<p>\n\u201cSkin diseases can profoundly impact people\u2019s lives &#8211; and at LEO Pharma, we are here to change that,\u201d said Christophe Bourdon, CEO of LEO Pharma. \u201cPartnering to bring SPEVIGO\u00ae to more patients is more than a strategic step &#8211; 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\u2019s 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.\u201d<\/p>\n<p>\nGPP 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 &#8211; often accompanied by fever, malaise, fatigue, and a risk of organ failure &#8211; while others endure persistent disease with intermittent flares.<sup>7891011<\/sup><\/p>\n<p>\nSPEVIGO<sup>\u00ae<\/sup> is available in more than 40 countries including the U.S., Japan, China, and most European countries to treat GPP flares in adults.<sup>4<\/sup> 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.<sup>5<\/sup> Additionally, SPEVIGO\u00ae has also been approved for expanded indications in generalized pustular psoriasis in the EU, U.S. and China.<sup>6<\/sup> SPEVIGO<sup>\u00ae<\/sup> is also under investigation for the treatment of other IL-36 mediated skin diseases.<\/p>\n<p>\nThe 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.<\/p>\n<p class=\"bwalignc\">\n<b>July, 2025<\/b><\/p>\n<p>\n<b>About Spevigo<\/b><\/p>\n<p>\nSPEVIGO\u00ae 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.<sup>123<\/sup><\/p>\n<p>\n<b>About generalized pustular psoriasis (GPP)<\/b><\/p>\n<p>\nGPP 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.<sup>78<\/sup> 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.<sup>89<\/sup> GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient\u2019s 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.<sup>81011<\/sup><\/p>\n<p>\n<b>About Boehringer Ingelheim<\/b><\/p>\n<p>\nBoehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry\u2019s 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 <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.boehringer-ingelheim.com%2F&amp;esheet=54289735&amp;newsitemid=20250714349390&amp;lan=en-US&amp;anchor=www.boehringer-ingelheim.com&amp;index=1&amp;md5=d156619b91202eac808e0f277018f6ca\" rel=\"nofollow\" shape=\"rect\">www.boehringer-ingelheim.com<\/a>.<\/p>\n<p>\n<b>About LEO Pharma<\/b><\/p>\n<p>\nLEO 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\u2019s 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 <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.leo-pharma.com&amp;esheet=54289735&amp;newsitemid=20250714349390&amp;lan=en-US&amp;anchor=www.leo-pharma.com&amp;index=2&amp;md5=3c3c6c8c5e4904055be430dc0224ca0e\" rel=\"nofollow\" shape=\"rect\">www.leo-pharma.com<\/a>.<\/p>\n<p>\n<sup>1<\/sup> 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\u20131551.<br \/>\n<br \/><sup>2<\/sup> 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.<br \/>\n<br \/><sup>3<\/sup> Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431\u20132440.<br \/>\n<br \/><sup>4<\/sup> Record on file.<br \/>\n<br \/><sup>5<\/sup> Boehringer Ingelheim. Spesolimab prevented generalized pustular psoriasis flares in Effisayil\u2122 2 trial. 2023. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.boehringer-ingelheim.com%2Fhuman-health%2Fskin-and-inflammatory-diseases%2Fgpp%2Fspesolimab-prevents-gpp-flares&amp;esheet=54289735&amp;newsitemid=20250714349390&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.boehringer-ingelheim.com%2Fhuman-health%2Fskin-and-inflammatory-diseases%2Fgpp%2Fspesolimab-prevents-gpp-flares&amp;index=3&amp;md5=3e32fba9146b6f3db96adb85dde73d69\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.boehringer-ingelheim.com\/human-health\/skin-and-inflammatory-diseases\/gpp\/spesolimab-prevents-gpp-flares<\/a> (Accessed 22 July 2024).<br \/>\n<br \/><sup>6<\/sup> Boehringer Ingelheim. European Commission approves SPEVIGO\u00ae for new and expanded indications in generalized pustular psoriasis. 2024. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.boehringer-ingelheim.com%2Fhuman-health%2Feuropean-commission-approves-spevigo-new-and-expanded-indications-generalized-pustular-psoriasis&amp;esheet=54289735&amp;newsitemid=20250714349390&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.boehringer-ingelheim.com%2Fhuman-health%2Feuropean-commission-approves-spevigo-new-and-expanded-indications-generalized-pustular-psoriasis&amp;index=4&amp;md5=cf726f8d3bc03057c33a14b982f8c644\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.boehringer-ingelheim.com\/human-health\/european-commission-approves-spevigo-new-and-expanded-indications-generalized-pustular-psoriasis<\/a> (Accessed 29 June 2025).<br \/>\n<br \/><sup>7<\/sup> Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13\u201319.<br \/>\n<br \/><sup>8<\/sup> 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\u2013273.<br \/>\n<br \/><sup>9<\/sup> Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21\u201329.<br \/>\n<br \/><sup>10<\/sup> Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907\u2013919.<br \/>\n<br \/><sup>11<\/sup> 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\u201371.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Boehringer Ingelheim<\/b><br \/>Tereza Urbankova, Senior Media Relations Manager<br \/>\n<br \/>E-Mail: <a target=\"_blank\" href=\"&#109;&#x61;&#x69;&#108;&#x74;&#x6f;:&#x70;&#x72;e&#115;&#x73;&#64;&#98;&#x6f;e&#104;&#x72;i&#110;&#x67;e&#114;&#x2d;&#x69;&#110;&#x67;&#x65;&#108;&#x68;&#x65;i&#x6d;&#x2e;c&#111;&#x6d;\" rel=\"nofollow\" shape=\"rect\">p&#114;&#101;&#x73;&#x73;&#64;b&#111;&#101;&#x68;&#x72;in&#103;&#101;&#x72;&#x2d;in&#103;&#x65;&#x6c;&#x68;e&#105;&#109;&#x2e;&#x63;&#x6f;m<\/a><br \/>Phone Number: +49 (6132) 77-184817<\/p>\n<p><b>LEO Pharma<\/b><br \/>Jeppe Ilkj\u00e6r, Media<br \/>\n<br \/>E-Mail: <a target=\"_blank\" href=\"&#x6d;&#x61;&#105;&#108;to&#x3a;&#x6a;&#x65;&#105;lk&#x40;&#x6c;&#x65;&#111;&#45;p&#x68;&#x61;&#x72;&#109;&#97;&#46;&#x63;&#x6f;&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#106;&#x65;i&#108;&#x6b;&#64;&#x6c;e&#111;&#x2d;p&#x68;&#x61;&#114;&#x6d;a&#46;&#x63;o&#x6d;<\/a><br \/>Phone Number: +45 3050 2014<\/p>\n<p>Christian Soerup Ryom, Investors<br \/>\n<br \/>E-Mail: <a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;t&#x6f;&#58;&#x63;&#x68;s&#x6f;&#101;&#64;&#x6c;&#101;&#x6f;&#45;p&#x68;&#97;r&#x6d;&#97;&#x2e;&#99;o&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#x63;&#x68;&#115;&#111;e&#x40;&#x6c;&#x65;&#111;&#45;p&#x68;&#x61;&#x72;&#109;&#97;&#46;&#x63;&#x6f;&#x6d;<\/a><br \/>Phone Number: +45 3089 9083<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Partnership will accelerate and broaden access to treatment for more patients with generalized pustular psoriasis (GPP), a rare and devastating skin condition LEO Pharma\u2019s six decades of dermatology expertise and Boehringer\u2019s global track record in bringing SPEVIGO\u00ae to over 40 countries will be combined to ensure continuous patient support Boehringer Ingelheim and LEO Pharma will &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/boehringer-ingelheim-and-leo-pharma-enter-partnership-to-commercialize-and-further-develop-spevigo-spesolimab\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61574","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO\u00ae (spesolimab) - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/boehringer-ingelheim-and-leo-pharma-enter-partnership-to-commercialize-and-further-develop-spevigo-spesolimab\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO\u00ae (spesolimab) - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Partnership will accelerate and broaden access to treatment for more patients with generalized pustular psoriasis (GPP), a rare and devastating skin condition LEO Pharma\u2019s six decades of dermatology expertise and Boehringer\u2019s global track record in bringing SPEVIGO\u00ae to over 40 countries will be combined to ensure continuous patient support Boehringer Ingelheim and LEO Pharma will ... 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