{"id":25245,"date":"2022-06-17T13:54:52","date_gmt":"2022-06-17T12:54:52","guid":{"rendered":"https:\/\/ppr-antibioresistance.inserm.fr\/?p=25245"},"modified":"2022-06-17T13:54:56","modified_gmt":"2022-06-17T12:54:56","slug":"shionogi-gardp-and-chai-announce-landmark-license-and-collaboration-agreements-to-treat-bacterial-infections-by-expanding-access-to-cefiderocol-in-135-countries","status":"publish","type":"post","link":"https:\/\/ppr-antibioresistance.inserm.fr\/fr\/informations-et-communications\/actualites\/shionogi-gardp-and-chai-announce-landmark-license-and-collaboration-agreements-to-treat-bacterial-infections-by-expanding-access-to-cefiderocol-in-135-countries\/","title":{"rendered":"Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements To Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries"},"content":{"rendered":"\n<p>Press release published on <a href=\"https:\/\/www.shionogi.com\/us\/en\/news\/2022\/06\/shionogi-gardp-and-chai-announce-landmark-license-and-collaboration-agreements-to-treat-bacterial-infections-by-expanding-access-to-cefiderocol-in-135-countries.html?utm_medium=email&amp;_hsmi=216684833&amp;_hsenc=p2ANqtz-9jd6pxu5An47HeR-XBqxNgRURXLbv38fTuBsVxnCanvOJelwBNLuQPuPNM7_V5lv6CZGqSELsowjUFchnzH7F2HqETUg&amp;utm_content=216684833&amp;utm_source=hs_email\" target=\"_blank\" rel=\"noreferrer noopener\">SHIONOGI website<\/a> on June 14, 2022<\/p>\n\n\n\n<p>Shionogi &amp; Co., Ltd. (Shionogi) and the Global Antibiotic Research and Development Partnership (GARDP) have today announced the execution of a license and technology transfer agreement and, with the Clinton Health Access Initiative (CHAI), a collaboration agreement that aim to significantly transform the landscape of access to antibiotics for countries around the world. <\/p>\n\n\n\n<p>The agreements will provide access to cefiderocol, an antibiotic for the treatment of serious Gram-negative bacterial infections, which may be resistant to other antibiotic treatments. Cefiderocol was recently added to the World Health Organization (WHO) Model List of Essential Medicines and targets a number of Gram-negative WHO priority pathogens. It was approved by the European Medicines Agency in 2020 and, separately, by the U.S. Food and Drug Administration in 2019. Please refer to the detailed U.S. indications and Important Safety Information for cefiderocol found below.<\/p>\n\n\n\n<p>This is the first license agreement for an antibiotic to treat serious bacterial infections between a pharmaceutical company and a non-profit organization driven by public health priorities. Under this agreement, GARDP will manufacture and commercialize cefiderocol through sub-licensees in a large range of countries that have delayed access (if any) to newer antibiotics. <\/p>\n\n\n\n<p>The license territory includes all low-income countries, most lower middle- and upper middle-income countries, and select high-income countries (135 countries total, almost 70% of countries worldwide). It includes a significant proportion of the world\u2019s population living in areas most affected by antibiotic resistance.\u201cShionogi is proud to work on such an innovative license agreement with GARDP and CHAI to accelerate antibiotic access. <\/p>\n\n\n\n<p>Shionogi is committed to ensuring that cefiderocol is accessible worldwide as a potential treatment option for certain highly resistant Gram-negative infections,\u201d stated Takuko Sawada, Director and Executive Vice President, Senior Vice President of Integrated Disease Care Division, Shionogi &amp; Co., Ltd.Antibiotic resistance is a growing public health emergency. <\/p>\n\n\n\n<p>A\u00a0<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)02724-0\/fulltext\" target=\"_blank\" rel=\"noreferrer noopener\">recent study<\/a>\u00a0found that antibiotic resistance caused nearly 1.3 million deaths worldwide in 2019 &#8211; almost double\u00a0<a href=\"https:\/\/www.who.int\/news\/item\/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis\" target=\"_blank\" rel=\"noreferrer noopener\">previous estimates<\/a>.\u201cToo often, antibiotic resistance is presented as a problem for the future,\u201d said Manica Balasegaram, Executive Director of GARDP. \u201cIn fact, resistant bacterial infections are already costing lives and taking a heavy toll on health systems around the world. We can change that by supporting accelerated access to antibiotics in regions with the highest burden of resistance &#8211; that is, where antibiotic access is often neglected, and should be prioritized. <\/p>\n\n\n\n<p>Thanks to essential support from our funding partners, and in collaboration with Shionogi and CHAI, GARDP is accelerating global access now, so that doctors and patients who urgently need antibiotics can get them. Antibiotic development and delivery go hand-in-hand in GARDP\u2019s efforts to fight antibiotic resistance.<\/p>\n\n\n\n<p>\u201dGetting cefiderocol to patients in need will require overcoming a number of technical, legal, regulatory and economic barriers. Shionogi and GARDP will collaborate with CHAI, which has expertise working with the public and private sectors to reshape markets and introduce medicines in countries around the world.\u201cAppropriate diagnosis and treatment of bacterial infections, which would include access to innovative medications like cefiderocol, can improve the treatment of life-threatening infections,\u201d stated David Ripin, Chief Science Officer and Executive Vice President of Infectious Diseases at CHAI. \u201cCHAI is excited to be a part of this partnership that will ensure that this innovative antibiotic is affordable and available to patients when and where they need it.<\/p>\n\n\n\n<p>\u201dThe collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programs that ensure appropriate use. These provisions are especially important to avoid fueling resistance to cefiderocol.According to Kamini Walia, Senior Scientist and Program Officer of AMR at the Indian Council of Medical Research, \u201cNew therapeutic options are urgently needed for treating highly resistant infections in Indian patients. Making cefiderocol available to appropriate Indian patients earlier than it was expected to hit Indian markets will be immensely beneficial in treating patients. However, there is need to practice strict stewardship around use of this drug to prevent its misuse and overuse.\u201d <\/p>\n\n\n\n<p>India is one of the many countries that may benefit from the license and collaboration agreements.This project has a broader purpose to pave the way for antibiotic access more generally. Shionogi and GARDP have agreed to publish their innovative license agreement, which may serve as a new baseline for similar agreements in the future. The license and collaboration agreements also offer a dynamic and promising collaborative approach to antibiotic access. By bringing together key actors from the private and non-profit sectors, this project may help overcome barriers so that cefiderocol reaches patients in need.<\/p>\n\n\n\n<p><strong>About Cefiderocol<\/strong><\/p>\n\n\n\n<p>Cefiderocol for injection is the first and only siderophore cephalosporin antibiotic for the treatment of serious Gram-negative infections. It has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells. <\/p>\n\n\n\n<p>Cefiderocol has also demonstrated\u00a0<em>in vitro<\/em>\u00a0activity against certain bacteria that contain problematic resistant enzymes such as ESBLs, AmpC, and serine- and metallo-carbapenemases. Data from multinational surveillance studies for cefiderocol demonstrated potent\u00a0<em>in vitro<\/em>\u00a0activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant\u00a0<em>A. baumannii complex, P. aeruginosa, Enterobacterales<\/em>\u00a0and\u00a0<em>S. maltophilia<\/em>. The clinical significance of the\u00a0<em>in vitro<\/em>\u00a0data is unknown. Cefiderocol has no clinically relevant\u00a0<em>in vitro<\/em>\u00a0activity against most Gram-positive bacteria and anaerobic bacteria.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.shionogi.com\/content\/dam\/shionogi\/si\/products\/pdf\/fetroja.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Click here<\/a>\u00a0for Full U.S. Prescribing Information for Fetroja\u00ae (cefiderocol).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Press release published on SHIONOGI website on June 14, 2022 Shionogi &amp; Co., Ltd. (Shionogi) and the Global Antibiotic Research and Development Partnership (GARDP) have today announced the execution of a license and technology transfer agreement and, with the Clinton Health Access Initiative (CHAI), a collaboration agreement that aim to significantly transform the landscape of [&hellip;]<\/p>\n","protected":false},"author":139,"featured_media":25253,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[31],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements To Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries - Interface nationale ANTIBIOR\u00c9SISTANCE<\/title>\n<meta name=\"description\" content=\"Informations, \u00e9v\u00e8nements et actualit\u00e9s autour de l&#039;Antibior\u00e9sistance en France et \u00e0 l&#039;international.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ppr-antibioresistance.inserm.fr\/fr\/informations-et-communications\/actualites\/shionogi-gardp-and-chai-announce-landmark-license-and-collaboration-agreements-to-treat-bacterial-infections-by-expanding-access-to-cefiderocol-in-135-countries\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements To Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries - 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