Bedaquiline Fumarate

TB Alliance's third licensed manufacturer makes pretomanid available through the Global Drug Facility, further improving affordability and access NEW YORK, April 24, 2025 /PRNewswire/ -- TB Alliance applauds a new milestone in the fight against drug-resistant tuberculosis (DR-TB): a 25% price reduction for pretomanid, a key component of the BPaL/M regimens. Pretomanid is now available through the Global Drug Facility (GDF) at just $169 per treatment course—less than $1 per day, a key pricing benchmark identified by the global TB advocacy community. This latest price drop—down from $364 upon pretomanid's initial approval in 2019, and down further from $224 in October 2024—reflects ongoing efforts by TB Alliance and its partners to broaden access and improve affordability through a multi-manufacturer approach to access. TB Alliance, a nonprofit organization that developed pretomanid, has pioneered an innovative access model by partnering with multiple quality-assured manufacturers. This strategy helped launch pretomanid at an initial low price and ensured rapid, sustainable, and affordable access across high-TB burden countries. Simultaneously, by enabling healthy competition and fostering multiple high-quality supply sources, TB Alliance's strategy expanded availability while driving down costs. "This progress demonstrates how thoughtful collaboration and planning can translate into real-world impact," said Dr. Mel Spigelman, President and CEO of TB Alliance. "By enabling multiple high-quality producers to supply this medicine, we're fostering a healthy and sustainable market to deliver on our mandate that the life-saving medicines we develop will be adopted, available, and affordable to all those in need. We're grateful to partners such as Lupin and GDF for their shared commitment to supplying the market with life-saving TB medicines and stand committed to working with all our manufacturing partners to ensure equitable and affordable access." The current GDF price reduction, led by Lupin Limited, represents a crucial step in delivering on this vision. Procurement through GDF will save an estimated $37 million annually according to The Stop TB Partnership, the organization responsible for managing GDF, allowing for the treatment of an additional 120,000 people with DR-TB. Together with recent price reductions for the other regimen components, the cost of a full BPaL/M treatment course has dropped to a new low of $310—less than $2 per day, and a 47% reduction from its December 2022 price. BPaL/M is a six-month treatment recommended by the World Health Organization to treat most forms of DR-TB. It consists of bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M). In 2024 alone, approximately 110,000 courses of pretomanid were ordered across the world—enough to treat more than 60% of the global market for DR-TB treatment, perhaps the fastest ever scale up for a new TB medicine in modern times. "Lupin is proud to collaborate with TB Alliance and the Global Drug Facility to make pretomanid, an essential medicine in the fight against multidrug-resistant TB, more accessible and affordable for TB patients across the globe," said Ramesh Swaminathan, Global CFO, Executive Director, Head of API Plus SBU at Lupin. "The recent price reduction reflects our strong and deep-rooted commitment to delivering high-quality and affordable medicines to TB patients worldwide. Through this partnership, we reaffirm our dedication to patient-centric innovation and equitable access, ensuring that countries burdened by TB have the necessary treatment options they need to save lives and strengthen public health systems." "For years, advocates from the TB community have called for TB treatments that are not just effective, but also affordable for every person who needs them," said Olya Klymenko, Development Director of TBPeopleUkraine. "The full BPaL/M regimen now costing less than $2 per day is deeply meaningful. We express our gratitude to everyone who made this result possible. There really is no reason for governments and health systems around the world to not provide these treatments to every person who can benefit from them." TB Alliance remains committed to expanding its innovative access model to ensure new innovations in TB treatment reach all who need them as rapidly as possible. With additional planned future tenders, TB Alliance expects additional price reductions for pretomanid in the future. Beyond pricing strategies, TB Alliance continues to develop and execute innovative market access initiatives like LIFT-TB, SLASH-TB, and the PeerLINC Knowledge Hub to speed the global uptake, procurement, and implementation of shortened DR-TB treatments for all who need them around the world. About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that all traces of the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Previously, less than two-thirds of drug-resistant TB patients around the world had been successfully treated. Treatment options were limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Media Contact: Jess Wiggs at [email protected] SOURCE TB Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

结核病（TB）是全球重要公共卫生问题，每年导致大量死亡和新增病例。卡介苗（BCG）是目前唯一获批的 TB 疫苗，但在预防成人肺结核和潜伏感染方面效果有限，因此研发新疫苗和治疗药物迫在眉睫。 1、结核疫苗抗原选择 MTB 抗原多样，包括细胞壁和荚膜抗原、分泌抗原等多种类型。生物信息学和人工智能助力筛选潜在抗原，如 EsxA、EsxB 等关键抗原在免疫反应和疫苗设计中作用重大，相关研究为疫苗开发奠定基础。 2、临床前和临床试验中的结核疫苗 临床前候选疫苗：减毒活疫苗（如 MTBΔsigH、MTBΔlpqS 等）、病毒载体疫苗（如 LV::li-HAEPA、SeV85AB 等）、重组 BCG 疫苗（如 rBCG::XB、BCG::ESX-1Mmar 等）、亚单位疫苗（如 CysVac2/Advax、LT70 等）、DNA 疫苗（如 DNA-hsp65）和 mRNA 疫苗（如 repRNA-ID91）等在动物模型中展现出一定的免疫原性和保护效果，为后续临床试验提供了依据。 临床试验中的疫苗：涵盖灭活疫苗（如 MIP、SRL172 等）、减毒活疫苗（如 MTBVAC、BCG 复种）、重组 BCG 疫苗（如 VPM1002）、亚单位疫苗（如 M72/AS01E、GamTBvac 等）、病毒载体疫苗（如 MVA85A、ChAdOx1.85A 等）和 mRNA 疫苗（如 BNT164a1、BNT164b1）等多种类型。不同疫苗在安全性、免疫原性和疗效方面各有特点，部分已取得积极进展。 3、结核治疗药物研发 一线抗结核药物用于治疗敏感结核病，二线药物用于治疗耐药结核病，如贝达喹啉（BDQ）、德拉马尼（DLM）等。宿主导向疗法（HDT）通过调节宿主免疫反应来辅助治疗，是新兴的治疗途径，但目前仍面临一些挑战。 4、面临的挑战与未来方向 挑战：TB 疫苗和药物研发面临抗原多样性、免疫逃逸、不同人群疫苗疗效差异、新型疫苗平台和递送系统的优化以及成本和可及性等问题，同时还需应对耐药菌的挑战。 未来方向：通过组合策略提高疗效，开发针对 MTB 新途径的化合物，改进 HDT 辅助治疗，推进个性化医疗，并加强国际合作，以加速 TB 疫苗和药物的研发与应用。