Latest news with #ShashankDeshpande
Hamilton Spectator
24-07-2025
- Business
- Hamilton Spectator
First half of 2025: Solid growth, investments and pipeline progress pave the way for two key launches in H2
Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported positive growth in the first half of 2025, with group net sales growing by 6.3%* to EUR 14.0 billion. This performance was driven by strong demand for key products in Human Pharma, namely JARDIANCE® with EUR 4.3 billion and OFEV® with EUR 2.0 billion, which continue to make a meaningful difference for patients worldwide. Building on this momentum, the company is advancing its late-stage pipeline with several therapies nearing regulatory approval. Among these are zongertinib for HER2-mutant lung cancer and nerandomilast for pulmonary fibrosis, both of which recently delivered positive pivotal results and are progressing towards potential launches in the second half of 2025. 'At Boehringer Ingelheim, our commitment to transforming lives for generations is more than a mission — it's a responsibility we carry forward every day. Therapies like JARDIANCE® and OFEV® continue to make a real difference to patients — they exemplify what's possible when true innovation addresses unmet medical needs,' said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma. 'At the same time, we're making strong progress across our pipeline — from obesity to liver and kidney health — with the goal of redefining standards of care. As we prepare for the potential launches of zongertinib and nerandomilast later this year, we remain focused on delivering meaningful solutions. We understand the urgency behind every patient's need, and we're acting with speed and purpose to meet it.' Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: 'In a volatile environment, we are delivering according to plan, with robust sales performance across our portfolio in human and animal health. As we prepare for major launches, we are investing more than ever – focusing on speed, scale, and impact to ensure we are ready to deliver innovative therapies to change the course of serious diseases. Beyond the excitement of new launches, we also see substantial growth potential in our established products, particularly with JARDIANCE®, which continue to make a meaningful difference for patients worldwide.' Human Pharma In the first half of 2025, Boehringer Ingelheim's Human Pharma business grew 5.7%* reaching EUR 11.3 billion in net sales. Growth was driven by solid global demand for key products, including EUR 4.3 billion in sales from JARDIANCE®, the treatment of chronic kidney diseases, type 2 diabetes and heart failure, and EUR 2.0 billion in sales from OFEV®, which is used to treat idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases. Boehringer Ingelheim's human pharma pipeline is strong, with over ten new Phase II and III trials starting in the next 12 to 18 months across our multiple therapeutic areas. These could lead to major product launches over the next five years, offering the potential to transform millions of lives. U.S. launches for zongertinib and nerandomilast are expected in the second half of 2025, pending FDA approval. Zongertinib, a targeted therapy for HER2-mutant advanced non-small cell lung cancer (NSCLC), showed durable response and clinically meaningful results in previously treated patients, with more than 70% of patients experiencing a tumor response. It is under regulatory review in U.S., Japan and China and being studied as a first-line treatment in a global Phase III trial. If approved, it would become the first orally administered targeted treatment for previously treated HER2-mutated lung cancer patients. Nerandomilast, a potential therapy for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), significantly slowed lung-function decline in the two FIBRONEER™ Phase III trials. It was well tolerated, with discontinuation rates comparable to placebo. Regulatory submissions have been made in the U.S., EU, China and Japan. The company also launched a Phase III trial for our DPP1/CatC inhibitor verducatib (BI 1291583) to evaluate its potential in treating bronchiectasis. Verducatib received FDA breakthrough therapy designation in 2024. In cardiovascular, renal, and metabolic (CRM) diseases, Boehringer Ingelheim started two new Phase III trials under the ongoing EASi trial program. In these trials, the company is investigating the potential benefits of an aldosterone synthase inhibitor/SGLT2i therapy in people with chronic heart failure and for cardiovascular risk reduction in people with type 2 diabetes, high blood pressure and cardiovascular disease. To support future launches and continued growth, the company is continuing to strengthen its global supply network. A key milestone is the EUR 300 million investment in its Yamagata site in Japan, with the opening of a new production unit, infrastructure measures and groundbreaking for an additional facility began in June. This expansion will position Japan as a critical production hub for the Asia and Oceania regions. At the same time Boehringer continues to strengthen its local production network in the USA, building on existing partnerships. Animal Health In the first six months of 2025, Boehringer Ingelheim's Animal Health Business delivered strong growth, with net sales increasing by 7.6%* to EUR 2.6 billion. This performance was driven by continued momentum in the parasiticide portfolio, particularly the NEXGARD® brand, which grew by 7.9%*. A key growth driver in Europe was BULTAVO 3™, a newly launched vaccine that protects cattle and sheep against bluetongue virus serotype 3 (BTV-3). BULTAVO 3™ is the first vaccine to prevent both clinical signs and mortality from BTV-3 and has been licensed in several European countries. The company also expanded its vaccine portfolio with the launch of VAXXITEK® HVT+IBD+H5, a trivalent poultry vaccine, offering protection against Marek's disease, Infectious Bursal Disease, and H5 avian influenza in a single shot. It was first introduced in Egypt in early 2025 and is designed for administration directly at the hatchery, providing early protection for chicks. In the companion animal segment, Boehringer Ingelheim entered a strategic digital health collaboration with Eko Health to improve early detection of heart disease in dogs. The partnership combines Boehringer's expertise in canine cardiology with Eko's AI-powered stethoscope technology, aiming to launch a dedicated mobile app for veterinarians in 2026. Outlook As Boehringer Ingelheim enters the second half of 2025, the company is well-positioned to build on its first-half year performance and expects a positive year-on-year increase in net sales. With major product launches, a robust pipeline, and strategic investments in R&D and manufacturing, Boehringer Ingelheim is set to expand its global impact and bring innovative health solutions to more patients and animals worldwide. Visit our half-year financial highlights page HERE . * on a comparable basis (adjusted for currency and other effects) 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 . Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Yahoo
15-07-2025
- Business
- Yahoo
LEO Pharma secures rights to Boehringer's Spevigo for $105m
Danish dermatology leader LEO Pharma has bought the rights to Boehringer Ingelheim's psoriasis drug Spevigo (spesolimab) for €90m ($105m), strengthening its portfolio ahead of a possible public listing in 2026. The transaction will see LEO gain the exclusive global licence for Spevigo, taking control of commercialisation and development rights. The full terms of the deal were not disclosed as both companies are privately owned, but LEO confirmed it is in line for milestone payments and royalties. The deal is expected to close in the second half of 2025. Spevigo is approved in the US, Japan, China and most European countries to treat generalised pustular psoriasis (GPP) flares, a rare but severe dermatological disease that can be fatal. It has also been approved in expanded indications in GPP in certain territories. LEO's new asset is a monoclonal antibody that 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. Indeed, GPP may not be the ceiling for Spevigo – LEO said there is an 'opportunity to investigate the potential of Spevigo in additional skin conditions with high unmet medical need in which IL-36 is implicated'. LEO calls Spevigo 'the flagship dermatology product' of Boehringer Ingelheim, though the drug's sales have not been publicly disclosed. Comparing sales from other drugs is tricky because Spevigo is the only US Food and Drug Administration (FDA)-approved treatment specifically for GPP. Boehringer Ingelheim's head of human pharma Shashank Deshpande said: '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.' Adding Spevigo to its portfolio represents a strengthening of assets for dermatology specialist LEO. The Danish drugmaker has been building its pipeline amid reports it is planning an initial public offering (IPO) next year. Christophe Bourdon, who was appointed CEO in 2022 and tasked with turning the fortunes of the company around, has made no secret of public listing plans. In an interview with Bloomberg yesterday [14 July], Bourdon said market conditions and shareholders' wishes will decide the best timing for an IPO. The deal with Boehringer Ingelheim marks the second time LEO has signed a licensing agreement with a big pharma company in 2025. In January, Gilead Sciences offered a potential $1.7bn for LEO's preclinical STAT6 research programmes, which the dermatology company agreed to. As part of the deal, LEO received $250m in an upfront payment, boosting its cash on hand. "LEO Pharma secures rights to Boehringer's Spevigo for $105m" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
14-07-2025
- Business
- Yahoo
Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO® (spesolimab)
Partnership will accelerate and broaden access to treatment for more patients with generalized pustular psoriasis (GPP), a rare and devastating skin condition LEO Pharma's six decades of dermatology expertise and Boehringer's global track record in bringing SPEVIGO® to over 40 countries will be combined to ensure continuous patient support Boehringer Ingelheim and LEO Pharma will closely cooperate to ensure a smooth transition of all operations INGELHEIM, Germany & BALLERUP, Denmark, July 14, 2025--(BUSINESS WIRE)--GLOBAL RELEASE - NOT INTENDED FOR UK MEDIA 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 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 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. (Accessed 22 July 2024).6 Boehringer Ingelheim. European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis. 2024. (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. View source version on Contacts Boehringer Ingelheim Tereza Urbankova, Senior Media Relations ManagerE-Mail: press@ Phone Number: +49 (6132) 77-184817LEO Pharma Jeppe Ilkjær, MediaE-Mail: jeilk@ Phone Number: +45 3050 2014Christian Soerup Ryom, InvestorsE-Mail: chsoe@ Phone Number: +45 3089 9083 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
14-07-2025
- Business
- Business Wire
Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO ® (spesolimab)
INGELHEIM, Germany & BALLERUP, Denmark--(BUSINESS WIRE)-- GLOBAL RELEASE - NOT INTENDED FOR UK MEDIA 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 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 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. (Accessed 22 July 2024). 6 Boehringer Ingelheim. European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis. 2024. (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.
Mid East Info
12-03-2025
- Business
- Mid East Info
Boehringer's nerandomilast meets primary endpoint in Phase III study FIBRONEER™-ILD, in progressive pulmonary fibrosis
Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus placebo The FIBRONEER™-ILD trial is the second Phase III trial in which the investigational compound nerandomilast has met its primary endpoint [1] Initial safety and tolerability results of the FIBRONEER™-trials are generally consistent with the Phase II results in IPF; full efficacy and safety data from FIBRONEER™-ILD will be shared in the second quarter of 2025 Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of PPF to the US Food & Drug Administration (FDA) and other health authorities worldwide Boehringer Ingelheim announced today that the FIBRONEER™-ILD trial met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 versus placebo. FVC is a measure of lung function. [2] Initial data readouts of the FIBRONEER™-trials support a generally consistent safety and tolerability profile when compared to the Phase II idiopathic pulmonary fibrosis (IPF) study, with overall adverse events comparable to those seen in the placebo group. 3 Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). [3] As it has not been approved for use, safety and efficacy have not been established. It is being investigated as part of the FIBRONEER™ global program, which includes two Phase III studies —FIBRONEER™-IPF [4] in people living with IPF and FIBRONEER™-ILD [5] in people living with progressive pulmonary fibrosis (PPF). Based on these results, Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of PPF to the US FDA and other health authorities worldwide. 'The positive FIBRONEER™-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges,' said Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim. 'The recent milestones of the FIBRONEER™ trial program underscore our commitment to transforming the lives of patients with this debilitating disease, and are a testament to Boehringer Ingelheim's position at the forefront of pulmonary fibrosis research.' About FIBRONEER™-ILD ( NCT05321082 )5 FIBRONEER™-ILD was a double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast (BI 1015550) over at least 52 weeks in patients with PPF. Primary endpoint: Absolute change from baseline in FVC (mL) at week 52. Key secondary endpoint: Time to the first occurrence of any of the components of the composite endpoint: time to first acute interstitial lung disease (ILD) exacerbation; first hospitalization for respiratory cause; or death (whichever occurs first) over the duration of the trial. Patients participating in the FIBRONEER™-ILD trial were treated with either oral nerandomilast 9 mg or 18 mg, or placebo, twice-daily, over at least 52 weeks. The 18 mg twice-daily dose of nerandomilast is supported by the results from the Phase II study.2 An additional 9 mg twice-daily dose of nerandomilast was added to evaluate the benefit-risk profile at a lower dose, as well as to provide further dose-response and exposure-response data.2 The trial has been conducted in more than 40 countries, more than 400 locations, and enrolled 1178 patients. About the FIBRONEER™ clinical program: The FIBRONEER™ program includes two Phase III randomized, double-blind, placebo-controlled trials — FIBRONEER™-IPF ( NCT05321069 )4 and FIBRONEER™-ILD ( NCT05321082 )5 — to investigate the efficacy, safety and tolerability of nerandomilast over at least 52 weeks in patients with IPF and in patients with PPF. In both trials, the primary endpoint is the absolute change from baseline in FVC (mL) at week 52.4,5 The key secondary endpoint is the time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trials. About nerandomilast: Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF and PPF.3,4,5 This compound is an investigational agent and has not been approved for use. The efficacy and safety of this investigational compound has not been established. Nerandomilast was granted FDA Breakthrough Therapy Designation for the treatment of IPF in February 2022. [6] The efficacy, safety, and tolerability of nerandomilast was studied in a Phase II randomized, double-blind, placebo-controlled trial of patients with IPF (n=147).3 The primary endpoint was a change from baseline in FVC (a measure of lung function) over a 12-week treatment period.3 About IPF and PPF: IPF is one of the more common progressive fibrosing interstitial lung diseases (ILD). [7] Symptoms of IPF include breathlessness during activity, a dry and persistent cough, fatigue and weakness. [8] Although considered 'rare,' IPF affects approximately 3 million people worldwide.8, [9] The disease primarily affects patients over the age of 50 and affects more men than women.8 Patients with certain types of non-IPF fibrosing ILD may also develop a progressive phenotype known as PPF. In ILDs other than IPF, progressive pulmonary fibrosis is defined by worsening respiratory symptoms, physiological evidence of disease progression and radiological evidence of disease progression. [10] Progressive pulmonary fibrosis can cause irreversible lung damage and lead to early mortality.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. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow.
