{"id":53792,"date":"2024-01-29T10:51:05","date_gmt":"2024-01-29T10:51:05","guid":{"rendered":"https:\/\/news.pakistaninewspaperlist.com\/alvotech-announces-positive-top-line-results-from-a-pharmacokinetic-study-for-avt03-a-proposed-biosimilar-for-prolia-and-xgeva\/"},"modified":"2024-01-29T10:51:05","modified_gmt":"2024-01-29T10:51:05","slug":"alvotech-announces-positive-top-line-results-from-a-pharmacokinetic-study-for-avt03-a-proposed-biosimilar-for-prolia-and-xgeva","status":"publish","type":"post","link":"https:\/\/pakistaninewspaperlist.com\/news\/alvotech-announces-positive-top-line-results-from-a-pharmacokinetic-study-for-avt03-a-proposed-biosimilar-for-prolia-and-xgeva\/","title":{"rendered":"Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia\u00ae and Xgeva\u00ae"},"content":{"rendered":"<div id=\"main-body-container\" itemprop=\"articleBody\">\n<ul>\n<li>\u00a0<em>The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia\u00ae in healthy adult subjects, met its primary endpoints<\/em><\/li>\n<li><em>Prolia\u00ae and Xgeva\u00ae (denosumab) are indicated for the treatment of bone disease<\/em><\/li>\n<\/ul>\n<p>Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia\u00ae and Xgeva\u00ae, which both contain denosumab. <\/p>\n<p>The PK study (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=tA33rYn2zPpBUMo27o_iT_cfDIawcCC3pgRQpbWfBSM0fC194sFkvP7JI5m86OKWvXtdAK8gDBasclbJAny9xrQ5KiAjs2Q3XrE8og7jahVXJKD3jfTLcwC9hZVvtnED\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>AVT03-GL-P01<\/u><\/a>), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia\u00ae in healthy adult subjects, met its primary endpoints. A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva\u00ae in healthy adult subjects.<\/p>\n<p>\u201cWe are very pleased with the progress in our AVT03 program. This milestone, and recent positive top-line results from other clinical studies clearly demonstrate our capabilities and the excellence of Alvotech\u2019s biosimilars development platform,\u201d said Joseph McClellan, Chief Scientific Officer.<\/p>\n<p>Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. \u00a0Xgeva, which is also denosumab but in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone.\u00a0 In the last twelve months before September 30, 2023, reported combined net revenues worldwide from sales of Prolia and Xgeva were over US$6 billion, based on the manufacturer\u2019s reported quarterly sales.<\/p>\n<p><strong>About AVT03 (denosumab)<\/strong><br \/>AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia\u00ae and Xgeva\u00ae (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand\/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.<\/p>\n<p>[1] <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xp7BlsA_jGnW-f3TxQFz328jm-4yoBHKysDQO9UwYDiXGCBlRyNroBAe_3ob3v8eRhXntN9GBhVJOaZIVQuxvUvBzUy2J4gR9IQXQ13i9QbN00jM7OoNPWlZ0oOFbMYqos_p90QPnDJ_Odi0SW4qNsgWhDTaWxgWnDiYCFSd4iB5efGiAyGDiEjlXziiRZ_QQIUJ5LNgfcMhjxVb3ibXm_stB0n64rsb_fPqrK9hsMS4AvvbLq57sMJU_eMXZkmQUYpCOAwUZv9xooOK_ZCzpQ==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>https:\/\/www.pi.amgen.com\/-\/media\/Project\/Amgen\/Repository\/pi-amgen-com\/Prolia\/prolia_pi.pdf<\/u><\/a><\/p>\n<p><strong>Use of trademarks<\/strong><br \/><em>Prolia and Xgeva are registered trademarks of Amgen Inc.<\/em><\/p>\n<p><strong>About Alvotech<\/strong><br \/>Alvotech 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. Alvotech\u2019s current pipeline includes eight 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\u2019s 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), 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 <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=IW6IVUyF1_w5MXsA9hz3vyR3-KeuPob857Efi-7KAxAfmFWxUn2X2LSsnLH0UQVxh336BDVdtFyjoyOZ8PhkGccfTUp-vosL1YrItdnhzjY=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>www.alvotech.com<\/u><\/a>. None of the information on the Alvotech website shall be deemed part of this press release.<\/p>\n<p><strong>Forward Looking Statements<\/strong><br \/>Certain statements in this communication may be considered \u201cforward-looking statements\u201d 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\u2019s 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, outcome of a reinspection of Alvotech\u2019s manufacturing facility, the satisfactory responses to the FDA\u2019s inspection findings and resolution of other deficiencies conveyed following the reinspection of Alvotech\u2019s manufacturing site, 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 \u201cmay\u201d, \u201cshould\u201d, \u201cexpect\u201d, \u201cintend\u201d, \u201cwill\u201d, \u201cestimate\u201d, \u201canticipate\u201d, \u201cbelieve\u201d, \u201cpredict\u201d, \u201cpotential\u201d, \u201caim\u201d or \u201ccontinue\u201d, 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\u2019s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing standards; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and\/or competitive factors; (6) Alvotech\u2019s estimates of expenses and profitability; (7) Alvotech\u2019s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech\u2019s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech\u2019s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech\u2019s current and future collaborations, joint ventures, partnerships or licensing arrangements; (15) Alvotech\u2019s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (16) Alvotech\u2019s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech\u2019s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA\u2019s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company\u2019s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled \u201cRisk Factors\u201d and \u201cCautionary Note Regarding Forward-Looking Statements\u201d 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.<\/p>\n<p><strong>CONTACTS<\/strong><br \/><strong>Investor Relations and Media Contact<\/strong><strong>: <\/strong><br \/>Benedikt Stefansson, Senior Director<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=8Iba4o1j9zgw48NmF7W7gvuwrjYihF54Gs_WhapV343I78yGD7u8X0HQfnSwuS9YXtvHjwOn1FKeVUrJA9739FKW_CvLda8cz-B0JUJF5IQ5a6kGlGGYlFEdt0uO7Olp\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><u>alvotech.ir@alvotech.com<\/u><\/a><\/p>\n<p>\n            <\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia\u00ae in healthy adult subjects, met its primary endpoints Prolia\u00ae and Xgeva\u00ae (denosumab) are indicated for the treatment of bone disease Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":53793,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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