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Malaysian Reserve
31-07-2025
- Business
- Malaysian Reserve
KIT Inhibitors Market Growth: Key Trends and Future Projections in the 7MM Upto 2034
The KIT inhibitors market remains highly competitive, driven by established players such as ONO Pharmaceutical and Blueprint Medicines, among others. At the same time, companies like Celldex Therapeutics, Cogent Biosciences, and Blueprint Medicines¸, among others, are actively advancing pipeline candidates across various stages of development. This sustained R&D activity reflects ongoing innovation and intensifying competition within the KIT-targeted therapy landscape. LAS VEGAS, July 31, 2025 /PRNewswire/ — DelveInsight's KIT Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Systemic Mastocytosis, Gastrointestinal Stromal Tumor (GIST), Chronic Spontaneous Urticaria (CSU), Graft-versus-host Disease (GvHD), Tenosynovial Giant Cell Tumor (TGCT), Advanced Systemic Mastocytosis (AdvSM), Non-advanced Systemic Mastocytosis (NonAdvSM), Indolent Systemic Mastocytosis (ISM), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging KIT inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the KIT Inhibitors Market Report As per DelveInsight's analysis, the total market size of KIT inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Systemic Mastocytosis, Gastrointestinal Stromal Tumor (GIST), Chronic Spontaneous Urticaria (CSU), Graft-versus-host Disease (GvHD), Tenosynovial Giant Cell Tumor (TGCT), Advanced Systemic Mastocytosis (AdvSM), Non-advanced Systemic Mastocytosis (NonAdvSM), Indolent Systemic Mastocytosis (ISM), and others. Leading KIT inhibitors companies, such as Celldex Therapeutics, Cogent Biosciences, Blueprint Medicines, and others, are developing novel KIT inhibitors that can be available in the KIT inhibitors market in the coming years. Some of the key KIT inhibitors in the pipeline include Barzolvolimab (CDX-0159), Bezuclastinib (CGT9486), Elenestinib (BLU-263), and others. Discover which indication is expected to grab the major KIT inhibitors market share @ KIT Inhibitors Market Report KIT Inhibitors Market Dynamics The KIT inhibitors market is shaped by a combination of growing clinical demand, limited therapeutic options, and ongoing advancements in targeted therapies. KIT, a receptor tyrosine kinase, plays a crucial role in cell growth and survival, and its mutations are strongly linked to malignancies such as gastrointestinal stromal tumors (GIST), systemic mastocytosis, and certain leukemias. The rising incidence of these cancers and the need for more effective treatments have fueled the demand for KIT inhibitors. However, the current landscape is dominated by a few branded drugs, such as AYVAKIT (avapritinib), QINLOCK (ripretinib), and ROMVIMZA (vimseltinib), with no generic options available, reflecting a relatively narrow competitive field. A key market driver is the increasing understanding of KIT-driven oncogenesis and the development of highly selective inhibitors that can overcome resistance to first-generation therapies. For example, mutations in the KIT gene often lead to resistance against older drugs like imatinib, pushing the need for next-generation inhibitors with improved efficacy and tolerability. In addition, strategic collaborations, licensing agreements, and FDA fast-track designations for KIT-targeting agents have accelerated innovation, further supporting market growth. Biopharmaceutical companies are also investing heavily in research to explore KIT inhibition beyond GIST, expanding the potential market size. Despite these opportunities, the KIT inhibitors market faces notable challenges. The high cost of branded therapies and strict reimbursement policies in several regions can limit patient access, especially in emerging economies. Moreover, the complexity of targeting KIT mutations, which often co-occur with other genetic alterations, makes drug development challenging and leads to high attrition rates in clinical trials. Competition from alternative treatment modalities, including immunotherapies and other targeted agents, also poses a threat to the growth of this niche segment. Looking ahead, the KIT inhibitors market is expected to witness steady growth as novel agents enter the pipeline and existing drugs gain approvals for expanded indications. Personalized medicine approaches, including genetic testing and biomarker-driven therapy selection, will play a critical role in shaping treatment protocols. Advances in drug design, such as allosteric inhibitors and combination regimens targeting resistance pathways, are likely to create new opportunities, making this a dynamic and evolving therapeutic area over the next decade. KIT Inhibitors Treatment Market The current landscape of US FDA-approved KIT inhibitors is relatively narrow, with only a few branded therapies available, such as ROMVIMZA (vimseltinib), AYVAKIT (avapritinib), and QINLOCK (ripretinib), and no generic alternatives on the market. This limited competition highlights the inherent challenges of effectively targeting KIT mutations. ROMVIMZA is an oral kinase inhibitor with high selectivity for the colony-stimulating factor 1 receptor (CSF1R). Preclinical research has shown that vimseltinib inhibits CSF1R autophosphorylation, blocks ligand-stimulated signaling, and reduces the proliferation of CSF1R-positive cells. It is indicated for adults with symptomatic TGCT where surgical resection would likely result in major functional impairment or severe complications. In February 2025, the US FDA approved ROMVIMZA for this indication. Previously, in July 2024, the EMA accepted the marketing authorization application (MAA) for vimseltinib in TGCT. The drug is also being evaluated in a Phase II trial for chronic GvHD. QINLOCK is a broad-spectrum tyrosine kinase inhibitor designed to target KIT and PDGFRA, including both wild-type and resistant primary and secondary mutations frequently seen in GIST. It also demonstrates in vitro activity against kinases such as PDGFRB, TIE2, VEGFR2, and BRAF. Clinically, QINLOCK is approved for adults with advanced GIST who have progressed after at least three prior kinase inhibitors, including imatinib, filling a critical therapeutic gap in later-line treatment. QINLOCK received FDA approval in May 2020, followed by European Commission approval in November 2021. AYVAKIT is a potent and selective tyrosine kinase inhibitor that targets key activating mutations in KIT and PDGFRA, including KIT D816V and PDGFRA D842V, with sub-nanomolar to low nanomolar activity in preclinical studies. It effectively inhibits autophosphorylation and cell proliferation in KIT-driven and PDGFRA-resistant models. Clinically, AYVAKIT is approved for unresectable or metastatic GIST with PDGFRA exon 18 mutations (including D842V), as well as AdvSM and ISM, but its use is restricted in patients with platelet counts below 50×10⁹/L. It was first approved by the FDA in January 2020 for adults with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations, including D842V—the first therapy to specifically target this mutation. The European Commission subsequently granted conditional marketing authorization under the name AYVAKYT in September 2020 for monotherapy in adults with unresectable or metastatic GIST carrying PDGFRA D842V mutations. Learn more about the KIT inhibitors @ KIT Inhibitors Analysis Key Emerging KIT Inhibitors and Companies A growing pipeline of KIT inhibitors is being investigated across a diverse set of indications beyond oncology, including CSU, multiple sclerosis, and GvHD. Prominent candidates such as barzolvolimab (CDX-0159), bezuclastinib (CGT9486), and elenestinib (BLU-263), among others, reflect this expanding therapeutic interest, signaling the potential of KIT-targeted therapies in addressing immune-mediated and inflammatory conditions. Barzolvolimab is a humanized monoclonal antibody that specifically targets the receptor tyrosine kinase KIT, effectively blocking its activity. By inhibiting KIT signaling, which regulates mast cell development, survival, and function, barzolvolimab tackles a critical driver of mast cell–mediated inflammatory processes. This mechanism is especially significant in diseases like chronic urticaria, where abnormal mast cell activation is central to disease progression. Barzolvolimab is in various stages of clinical development for multiple inflammatory disorders, including chronic spontaneous urticaria, chronic inducible urticaria, eosinophilic esophagitis, prurigo nodularis, and atopic dermatitis, with CSU being the most advanced program, currently in Phase III. At the EAACI Congress in June 2025, Celldex Therapeutics presented strong Phase II data showing durable complete responses and notable quality-of-life improvements at 76 weeks, extending well beyond the dosing period. Additional data revealed significant reductions in angioedema at 52 weeks, reinforcing barzolvolimab's potential as a transformative therapy for CSU. Bezuclastinib (CGT9486) is a highly selective and potent tyrosine kinase inhibitor (TKI) that targets the KIT D816V mutation, a primary driver in most systemic mastocytosis cases, as well as other KIT exon 17 mutations often found in advanced gastrointestinal stromal tumors. It is being developed for patients with non-advanced systemic mastocytosis (NonAdvSM), advanced systemic mastocytosis (AdvSM), and GIST. In February 2025, Cogent Biosciences presented data on the efficacy and safety of bezuclastinib in adult patients with NonAdvSM from the Phase II SUMMIT trial at the AAAAI Annual Meeting (February 28–March 3, 2025). Cogent Biosciences aims to achieve key milestones for bezuclastinib in 2025: release top-line Phase II SUMMIT trial data for NonAdvSM in July; report Phase II APEX trial results in AdvSM in the second half of the year; submit the first New Drug Application (NDA) by year-end; and present top-line results from the pivotal Phase III PEAK trial in imatinib-resistant GIST patients by late 2025. Elenestinib (BLU-263) is an investigational oral, potent, and highly selective inhibitor of KIT D816V, designed for the treatment of indolent systemic mastocytosis (ISM) and other mast cell disorders. It is engineered to offer similar potency to avapritinib while minimizing off-target effects and central nervous system penetration. Elenestinib is currently being studied in the ongoing registration-enabling Phase II/III HARBOR trial in ISM, which includes a dose-finding Part 1, a registration-focused Part 2, and a long-term treatment Part 3. Top-line 12-week results from Part 1 of the HARBOR trial were announced in December 2022 and subsequently presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023. The anticipated launch of these emerging therapies is poised to transform the KIT inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the KIT inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about KIT inhibitors clinical trials, visit @ KIT Inhibitors Treatment KIT Inhibitors Overview KIT inhibitors are a class of targeted therapies designed to block the activity of the KIT receptor tyrosine kinase, which plays a crucial role in cell proliferation, survival, and differentiation. Mutations or overactivation of KIT are implicated in several malignancies, including gastrointestinal stromal tumors and mastocytosis. By inhibiting KIT signaling, these drugs disrupt oncogenic pathways and help control tumor growth or abnormal cell proliferation. The therapeutic development of KIT inhibitors continues to evolve, with newer agents being designed to overcome resistance mechanisms associated with first-generation TKIs. Resistance often arises due to secondary mutations in the KIT gene, leading to reduced drug binding and diminished efficacy. Advanced KIT inhibitors have been developed to address these resistance mutations by offering broader and more potent inhibition across multiple KIT variants. Ongoing research is focused on combination therapies, improved selectivity, and minimizing adverse effects, aiming to expand the clinical utility of KIT inhibitors across a wider range of cancers and other KIT-mediated disorders. KIT Inhibitors Epidemiology Segmentation The KIT inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for KIT Inhibitor Total Eligible Patient Pool in Selected Indications for KIT Inhibitor Total Treated Cases in Selected Indications for KIT Inhibitor KIT Inhibitors Report Metrics Details Study Period 2020–2034 KIT Inhibitors Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report Systemic Mastocytosis, Gastrointestinal Stromal Tumor (GIST), Chronic Spontaneous Urticaria (CSU), Graft-versus-host Disease (GvHD), Tenosynovial Giant Cell Tumor (TGCT), Advanced Systemic Mastocytosis (AdvSM), Non-advanced Systemic Mastocytosis (NonAdvSM), Indolent Systemic Mastocytosis (ISM), and others Key KIT Inhibitors Companies Celldex Therapeutics, Cogent Biosciences, Blueprint Medicines, ONO Pharmaceutical (Deciphera Pharmaceuticals), Blueprint Medicines, and others Key KIT Inhibitors Barzolvolimab (CDX-0159), Bezuclastinib (CGT9486), Elenestinib (BLU-263), ROMVIMZA (vimseltinib), QINLOCK (ripretinib), AYVAKIT/AYVAKYT (avapritinib), and others Scope of the KIT Inhibitors Market Report KIT Inhibitors Therapeutic Assessment: KIT Inhibitors current marketed and emerging therapies KIT Inhibitors Market Dynamics: Conjoint Analysis of Emerging KIT Inhibitors Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, KIT Inhibitors Market Access and Reimbursement Discover more about KIT inhibitors in development @ KIT Inhibitors Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Key Events 5 Market Forecast Methodology 6 KIT Inhibitor Market Overview at a Glance in the 7MM 6.1 Market Share (%) Distribution by Indication in 2024 6.2 Market Share (%) Distribution by Indication in 2034 7 KIT Inhibitor: Background and Overview 7.1 Introduction 7.2 Evolution of KIT Inhibitor 7.3 Treatment 8 Target Patient Pool 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.3 Epidemiology Scenario in the 7MM 8.3.1 Total Cases in Selected Indications for KIT Inhibitor in the 7MM 8.3.2 Total Eligible Patient Pool in Selected Indications for KIT Inhibitor in the 7MM 8.3.3 Total Treated Cases in Selected Indications for KIT Inhibitor in the 7MM 8.4 The US 8.5 EU4 and the UK 8.6 Japan 9 Marketed Therapies 9.1 Key Cross Competition 9.2 ROMVIMZA (vimseltinib): ONO Pharmaceutical (Deciphera Pharmaceuticals) 9.2.1 Product Description 9.2.2 Regulatory Milestones 9.2.3 Others Developmental Activities 9.2.4 Clinical Trials Information 9.2.5 Safety and Efficacy 9.3 QINLOCK (ripretinib): ONO Pharmaceutical (Deciphera Pharmaceuticals) 9.4 AYVAKIT/AYVAKYT (avapritinib): Blueprint Medicines List of drugs to be continued in the final report… 10 Emerging Therapies 10.1 Key Cross Competition 10.2 Barzolvolimab (CDX-0159): Celldex Therapeutics 10.2.1 Drug Description 10.2.2 Others Developmental Activities 10.2.3 Clinical Trials Information 10.2.4 Safety and Efficacy 10.2.5 Analyst's View 10.3 Bezuclastinib (CGT9486): Cogent Biosciences 10.4 Elenestinib (BLU-263): Blueprint Medicines List of drugs to be continued in the final report… 11 KIT Inhibitor: the 7MM Analysis 11.1 Key Findings 11.2 Key Market Forecast Assumptions 11.2.1 Cost Assumptions and Rebates 11.2.2 Pricing Trends 11.2.3 Analogue Assessment 11.2.4 Launch Year and Therapy Uptakes 11.3 Market Outlook 11.4 Attribute Analysis 11.5 Total Market Size of KIT Inhibitor in the 7MM 11.6 The US Market Size 11.6.1 Total Market Size of KIT Inhibitor in the US 11.6.2 Market Size of KIT Inhibitor by Therapies in the US 11.7 EU4 and the UK Market Size 11.7.1 Total Market Size of KIT Inhibitor in EU4 and the UK 11.7.2 Market Size of KIT Inhibitor by Therapies in EU4 and the UK 11.8 Japan Market Size 11.8.1 Total Market Size of KIT Inhibitor in Japan 11.8.2 Market Size of KIT Inhibitor by Therapies in Japan 12 Unmet Needs 13 SWOT Analysis 14 KOL Views 15 Market Access and Reimbursement 15.1 The US 15.2 EU4 and the UK 15.3 Japan 16 Acronyms and Abbreviations 17 Bibliography Related Reports Gastrointestinal Stromal Tumor Market Gastrointestinal Stromal Tumor Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key GIST companies, including Jiangsu Hengrui Medicine, Daiichi Sankyo Company, Cogent Biosciences, Advenchen Laboratories, AB Science, Immunicum AB, Novartis, Bristol-Myers Squibb, Hanmi Pharmaceutical Company Limited, Ascentage Pharma, Array BioPharma, Plexxikon, Arog Pharmaceuticals, Xencor Inc., DNAtrix Inc., Onyx Pharmaceuticals, Exelixis, Allarity Therapeutics, Theseus Pharmaceuticals, IDRx Inc., Allarity Therapeutics, among others. Chronic Spontaneous Urticaria Market Chronic Spontaneous Urticaria Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CSU companies, including Celldex Therapeutics, Novartis, Sanofi, Incyte, Jasper Therapeutics, InflaRx, Evommune, Otsuka Holdings (Taiho Pharmaceutical), among others. Graft Versus Host Disease Market Graft Versus Host Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key GvHD companies, including CSL Behring, Equillium, Biocon, MaaT Pharma, REGiMMUNE, ReAlta Life Sciences, Ono Pharmaceutical (Deciphera Pharmaceuticals), Medsenic, BioSenic, ASC Therapeutics, Cynata Therapeutics, Evive Biotech (Yifan Pharmaceutical), Ironwood, medac, among others. Systemic Mastocytosis Market Systemic Mastocytosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key systemic mastocytosis companies, including AB Sciences, Blueprint Medicines, Patara Pharma, Seagen Inc., GT Biopharma, Deciphera Pharmaceuticals, Novartis Oncology, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:
Yahoo
25-06-2025
- Business
- Yahoo
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
REYKJAVIK, Iceland and PISCATAWAY, N.J. and LONDON, June 25, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC ('Kashiv'), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited ('Advanz Pharma'), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic. The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair® in patients with Chronic Spontaneous Urticaria (CSU), who remained symptomatic despite treatment with H1 antihistamines. The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks over a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 between the treatment groups of ADL-018 and reference product. 'The positive results from this confirmatory patient study represent an important step in the development of the Xolair® biosimilar candidate. We look forward to working with our partners to increase global patient access to this important medicine,' said Joseph McClellan, Chief Scientific Officer of Alvotech. 'This marks a positive advancement for Kashiv's growing biosimilar pipeline in addition to its current portfolio of Releuko® and Fylnetra®. We look forward to collaborating with regulatory authorities to make this treatment available to patients,' said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, 'We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Alvotech and Advanz Pharma.' 'The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR® mark an important milestone in Advanz Pharma's ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia.' said Nick Warwick, Chief Medical Officer at Advanz Pharma. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated and accepted the marketing authorization application (MAA) for AVT23 earlier this year, and the filing of an MAA with the European Medicines Agency (EMA) is expected before the end of the year. About AVT23AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair®, which contains omalizumab, is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy [1]. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Alvotech partnered with Kashiv BioSciences for the development of the proposed Xolair® biosimilar, which is referred to as AVT23 by Alvotech and as ADL-018 by Kashiv Biosciences. Use of trademarksXolair® is a registered trademark of Novartis AG. Sources[1] MHRA Product Information for Xolair® About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy's (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Alvotech Forward Looking StatementsCertain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech's expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential', 'aim' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability get marketing approval for AVT23 in the UK and other jurisdictions; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech's estimates of expenses and profitability; (6) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech's ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company's business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. About Advanz PharmaPartner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma's product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Advanz Pharma Forward Looking StatementsCertain statements in this press release are forward-looking statements. These statements may be identified by words such as 'anticipate', "expectation", "belief', "estimate", "plan", "target', 'project', 'will', 'may', 'should' or "forecast" and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma's markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. About Kashiv BioSciences:Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together 'Kashiv BioSciences') operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. CONTACTS Alvotech Investor Relations and Global CommunicationsBenedikt Stefansson, Advanz Pharma Global Corporate CommunicationsCourtney Kashiv BiosciencesDr. Paras
Yahoo
25-06-2025
- Business
- Yahoo
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
REYKJAVIK, ICELAND, PISCATAWAY, NEW JERSEY AND LONDON, UK (June 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC ('Kashiv'), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited ('Advanz Pharma'), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic. The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair® in patients with Chronic Spontaneous Urticaria (CSU), who remained symptomatic despite treatment with H1 antihistamines. The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks over a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 between the treatment groups of ADL-018 and reference product. 'The positive results from this confirmatory patient study represent an important step in the development of the Xolair® biosimilar candidate. We look forward to working with our partners to increase global patient access to this important medicine,' said Joseph McClellan, Chief Scientific Officer of Alvotech.'This marks a positive advancement for Kashiv's growing biosimilar pipeline in addition to its current portfolio of Releuko® and Fylnetra®. We look forward to collaborating with regulatory authorities to make this treatment available to patients,' said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, 'We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Alvotech and Advanz Pharma.' 'The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR® mark an important milestone in Advanz Pharma's ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia.' said Nick Warwick, Chief Medical Officer at Advanz Pharma. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated and accepted the marketing authorization application (MAA) for AVT23 earlier this year, and the filing of an MAA with the European Medicines Agency (EMA) is expected before the end of the year. About AVT23AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair®, which contains omalizumab, is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy [1]. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Alvotech partnered with Kashiv BioSciences for the development of the proposed Xolair® biosimilar, which is referred to as AVT23 by Alvotech and as ADL-018 by Kashiv Biosciences. Use of trademarksXolair® is a registered trademark of Novartis AG. Sources[1] MHRA Product Information for Xolair® About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy's (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Alvotech Forward Looking StatementsCertain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech's expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential', 'aim' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability get marketing approval for AVT23 in the UK and other jurisdictions; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech's estimates of expenses and profitability; (6) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech's ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company's business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. About Advanz PharmaPartner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma's product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Advanz Pharma Forward Looking StatementsCertain statements in this press release are forward-looking statements. These statements may be identified by words such as 'anticipate', "expectation", "belief', "estimate", "plan", "target', 'project', 'will', 'may', 'should' or "forecast" and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma's markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. About Kashiv BioSciences: Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together 'Kashiv BioSciences') operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. CONTACTS Alvotech Investor Relations and Global CommunicationsBenedikt Stefansson, Advanz Pharma Global Corporate CommunicationsCourtney Kashiv BiosciencesDr. Paras 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
Zawya
01-06-2025
- Business
- Zawya
Novartis and Kuwait Society of Dermatologists enter strategic partnership to advance dermatological care in Kuwait
Under the title 'United for Dermatology', the partnership will drive awareness, disease understanding, and improve the lives of patients in Kuwait diagnosed with Psoriasis, Hidradenitis Suppurativa & Chronic Spontaneous Urticaria Kuwait City, Kuwait – Novartis, a global leader in innovative medicines, signed a partnership agreement with the Kuwait Society of Dermatologists, focused on transforming dermatological care in Kuwait. This strategic partnership will prioritize high-impact immunological skin conditions such as Psoriasis, Hidradenitis Suppurativa (HS) and Chronic Spontaneous Urticaria (CSU) with a shared goal of bridging diagnostic gaps and improving the quality of life for patients. Together, Psoriasis, Hidradenitis Suppurativa (HS), and Chronic Spontaneous Urticaria (CSU) represent distinct chronic inflammatory skin diseases, each with unique clinical presentations and significant impact on quality of life. Beyond physical symptoms, conditions like Psoriasis, Hidradenitis Suppurativa and CSU often take a significant toll on patients' mental health, contributing to anxiety, depression and social isolation—underscoring the importance of timely, compassionate and comprehensive care. This partnership is focused on increasing education and disease awareness within the public and HCPs, in addition to evidence-driven solutions that ensure faster, more accurate diagnoses and better treatment outcomes. Dr. Atlal Allafi, President, Kuwait Society of Dermatologists, said, 'Our partnership with Novartis is focused on breaking down barriers to care. Together, we're working to empower patients to recognize symptoms earlier and support physicians in identifying these conditions sooner. By accelerating diagnosis and access to treatment, we aim to enhance patient outcomes and overall well-being.' Rabab Monir, Country Operations Head - Kuwait, Novartis, added, 'Driven by our mission to transform the future of medicine, Novartis is proud to join forces with the Kuwait Society of Dermatologists to elevate dermatological care across Kuwait. Through this collaboration, we're fostering a healthcare environment where early intervention and personalized treatment pave the way for improved patient outcomes.' A professional organization for dermatologists in Kuwait, the Kuwait Society of Dermatologists is dedicated to advancing dermatological care through education, research, and public awareness. Committed to the highest standards of medical ethics and excellence, the society plays a key role in promoting skin health across the nation. Dr Abeer Albazali, Vice President, Kuwait Society of Dermatologists, commented, 'We aim to foster collaboration among dermatologists, encouraging the exchange of knowledge and best practices that drive progress in patient care. This partnership empowers us to move from dialogue to delivery—bringing global breakthroughs to life through locally tailored solutions.' Through this collaboration, Novartis and the Kuwait Society of Dermatologists reinforce their mutual commitment to a future where patients benefit from early diagnosis, individualized care, and an improved quality of life. Disease Descriptors Chronic Spontaneous Urticaria (CSU) is a medical condition that affects 0.5-1 per cent of the global population and is characterized by chronic hives that last for six weeks or longer. These hives can appear without an obvious trigger and may cause significant itching and discomfort. Hidradenitis Suppurativa (HS) is a chronic skin condition more common in women and often undiagnosed, marked by recurrent, painful lumps or nodules under the skin. These lesions often become inflamed, can rupture, and may lead to scarring over time. Psoriasis is a chronic autoimmune skin disorder characterized by thick, red, scaly plaques on the skin. These lesions can be itchy, painful, and sometimes extensive. It is estimated that between 1 and 3 per cent of the population across countries in the Gulf are affected by this condition. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.
Zawya
30-04-2025
- Health
- Zawya
Novartis and Emirates Dermatology Society renew strategic partnership to advance dermatological care in UAE
In an era of rapid medical innovation and information overload, diagnostic accuracy and clinical authenticity are crucial to eliminating delays, preventing misdiagnoses and ultimately enhancing patient outcomes Dubai, UAE – Novartis, a global leader in innovative medicines and the Emirates Dermatology Society (EDS) today announced the renewal of their partnership focused on revolutionizing dermatological care in the United Arab Emirates. Now entering its third year, the collaboration continues to prioritize high-impact immunological skin conditions such as Psoriasis, Hidradenitis Suppurativa (HS) and Chronic Spontaneous Urticaria (CSU) with a shared goal of closing diagnostic gaps and improving the quality of life for patients. While dermatology has made tremendous strides in the past few years, there is still an opportunity to accelerate the diagnosis and care for patients across the UAE. Beyond physical symptoms, conditions like Psoriasis, Hidradenitis Suppurativa and CSU often take a significant toll on patients' mental health, contributing to anxiety, depression and social isolation—underscoring the importance of timely, compassionate and comprehensive care. Chronic Spontaneous Urticaria (CSU) is a medical condition characterized by chronic hives that last for six weeks or longer. These hives can appear without an obvious trigger and may cause significant itching and discomfort. Hidradenitis Suppurativa (HS) is a chronic skin condition marked by recurrent, painful lumps or nodules under the skin. These lesions often become inflamed, can rupture, and may lead to scarring over time. Psoriasis is a chronic autoimmune skin disorder characterized by thick, red, scaly plaques on the skin. These lesions can be itchy, painful, and sometimes extensive. Together, Psoriasis, Hidradenitis Suppurativa (HS), and Chronic Spontaneous Urticaria (CSU) represent distinct chronic inflammatory skin diseases, each with unique clinical presentations and significant impact on quality of life. This partnership is focused on addressing these challenges with evidence-driven solutions that ensure faster, more accurate diagnoses and better treatment outcomes. 'The partnership with Novartis is about proactively addressing the barriers to care. We are committed to helping physicians recognize these conditions earlier, ensuring patients receive timely treatment and improving their overall well-being,' said Dr. Ayman Alnaeem, President, Emirates Dermatology Society. 'At Novartis, our commitment to reimagining medicine drives us to collaborate with organizations like EDS to advance dermatological care in the Gulf region. Together, we are building a healthcare ecosystem where timely, personalized care leads to better patient outcomes,' added Mohamed Ezz Eldin, Head of GCC, Novartis. The Emirates Dermatology Society (EDS) is not just a professional network—it is a leading force in shaping the future of dermatological care in the UAE. With an active management committee overseeing its activities, EDS plays a crucial role in connecting dermatologists, facilitating knowledge-sharing and promoting excellence in dermatology 'Our goal is to bring dermatologists together to collaborate, share insights and contribute to the ongoing evolution of care. This partnership allows us to turn discussions into action—translating global innovations into local solutions,' commented, Dr Raghda Al Maashari, Cultural Committee Chairperson, Emirates Dermatology Society. With this partnership, Novartis and EDS reaffirm their shared vision: a future where every patient has access to timely diagnosis, personalized treatment and a better quality of life. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.
