Linezolid

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

Persica Pharmaceuticals on Wednesday reported encouraging findings from an early-stage study of PP353, an intradiscally administered antibiotic-based therapy, in chronic low back pain (cLBP). Specifically, the therapy showed substantial pain and disability reductions in patients with Modic Type 1 vertebral changes — a condition estimated to affect nearly 4 million individuals in the US, EU and Japan.According to the company, the two-dose treatment — which combines the antibiotic linezolid, the contrast agent iohexol and a thermosensitive gel — is based on evidence that cLBP can be caused by bacterial infection of the disc. PP353 is directly injected into the degenerate lumbar disc, thereby offering a prolonged high-concentration exposure at the affected site. The Phase Ib Modic trial enrolled 44 patients with cLBP associated with Modic Type 1 changes and who had failed to benefit from existing non-surgical treatments. The participants were randomised to receive either PP353 or placebo and followed up for 12 months. Top-line results showed that PP353 met its primary endpoint, with pain reduction of 3.4 points (50%) from baseline and 1.4 points (30%) versus placebo at 12 months. Moreover, the PP353 group showed clinically meaningful reductions in pain and disability as early as three months and one month, respectively from treatment initiation, with continued improvements at 12 months. On the safety front, the therapy was well tolerated, with no dose-limiting gastrointestinal side effects reported.“The results…bring us closer to our mission of delivering a new and effective treatment option for patients underserved by current therapies,” said Steve Ruston, chief executive of Persica, adding that the study provides “further compelling evidence of the role of infection in patients with cLBP and Modic 1 changes.” The pharma is now preparing for discussions with regulatory authorities about advancing to registrational trials.