Bedaquiline Fumarate

MANILA (September 3, 2024) – A delegation of experts from Brazil’s National TB Program visited Manila recently to collaborate with the Philippines to accelerate implementation of the new drug-resistant TB (DR-TB) treatment, BPaL/M. Through the Manila-based PeerLINC Knowledge Hub, Brazilian officials had in-depth scientific exchange with their peers in the Philippines – one of the first countries in the world to successfully roll out BPaL/M treatment. PeerLINC is supported by TB Alliance and offers countries like Brazil first-in-class peer support, capacity building, and technical assistance to implement the life-saving regimen in their own countries. BPaL/M – a combination of the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M) – are six-month DR-TB treatments with a success rate of 90% or greater. BPaL/M is recommended by the World Health Organization (WHO) for the treatment of most forms of DR-TB. Prior to the introduction of these regimens, DR-TB treatment typically consisted of 9-24 months of treatment, with a treatment success rate of approximately 60%. New regimens have the potential to improve DR-TB treatment outcomes and experiences in Brazil, while reducing costs to both health systems and individuals who seek treatment. “Brazil has decided to fast track implementation of BPaL/M,” says Dr. Fernanda Dockhorn. “We had valuable interactions with the PeerLINC team and Philippines Department of Health Disease Prevention and Control Bureau (DPCB) experts to utilize their experience as we deploy this new standard of care in our country. We are thankful to TB Alliance for supporting this interaction and DPCB for their help.” The intensive week-long programme included didactic and hands-on training with experts from PeerLINC, the Philippines Department of Health, the Lung Center of the Philippines, and the National TB Reference Laboratory (NTRL). The PeerLINC team also provides ongoing support and technical assistance as Brazil implements the new treatment regimens. “It is truly heartening and exciting to see this initiative working so well,” said Sandeep Juneja, Senior Vice President of Access at TB Alliance. “We’re seeing countries with substantial TB burdens working with the PeerLINC team and returning home with deeper knowledge, strengthened commitment, and tangible plans to expand and accelerate access to new TB cures that will benefit their people and health systems.” PeerLINC Knowledge Hub operates as a partnership between TB Alliance and the Tropical Disease Foundation, Inc. (TDF), and in close collaboration with the Department of Health (DOH), Philippines, to help countries implement best practices in the treatment of drug-resistant tuberculosis (DR-TB) and speed the worldwide programmatic implementation of innovative, more effective treatments for the disease. The initiative is funded by the Australian Government through the Partnerships for a Healthy Region initiative. Since launching in March 2024, PeerLINC has helped numerous counties define and operationalize plans to expand availability of the BPaL/M, including Brazil, Peru, Nigeria, Rwanda, and Democratic Republic of Congo. About BPaL The BPaL regimen – which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L) – was designed and 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. Prior to the initial BPaL clinical trial, less than one-third of drug-resistant TB patients were being 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 PeerLINC The PeerLINC Knowledge Hub provides practical training and technical support to help speed programmatic implementation of innovative, effective TB treatments globally. PeerLINC follows a peer-to-peer model for sharing best practices, experience, tools, and materials by connecting experts from early adopter countries with countries interested in implementing the latest TB treatments. PeerLINC, operates in partnership between the Tropical Disease Foundation, Inc. (TDF) and TB Alliance in close collaboration with the Department of Health, Philippines. PeerLINC Knowledge Hub New PeerLINC Knowledge Hub will Leverage Local Expertise and Experience to Accelerate New, More Effective TB Cures Around the World Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB

The new price in South Africa matches the figure Johnson & Johnson charges the Global Drug Facility for Sirturo, according to South Africa's Competition Commission. A storm of scrutiny relating to Johnson & Johnson’s pricing and patenting of its tuberculosis med bedaquiline (branded as Sirturo) is clearing up after reaching a fever pitch last year. South African antitrust authorities have dropped (PDF) an investigation they opened into J&J last summer after the drugmaker and its Janssen subsidiary filed for a secondary patent that sought to fend off generics until 2027. The country’s Competition Commission decided not to move forward with a complaint after “extensive engagements” with the Sirturo maker, the commission said in a press release. Along with J&J's prior commitment to not enforce its Sirturo patent in 134 low-and middle-income countries (including South Africa), the company agreed to slash the South African government's procurement price by 40%. The new price matches the figure that J&J offers to the Stop TB Partnership’s Global Drug Facility (GDF), according to the commission. GDF supplies the med to “the majority of low-and middle-income countries,” J&J has said. Last year, J&J cut its Sirturo prices for GDF by 55% in what the organization called a “historic price reduction.” However, the GDF deal left out several countries with a high burden of multidrug-resistant tuberculosis, including South Africa, Belarus and Ukraine, global health initiative Unitaid said at the time. Soon after disclosing its GDF partnership, J&J widened its pact and pledged to not enforce Sirturo patents in certain low-and middle-income countries, allowing generics makers to sell their own versions of the med if they are “of good quality, medically acceptable” and used only in the appropriate countries. The move came after several advocacy groups, such as Unitaid and Médecins Sans Frontières, pressed the company to expand access to the drug. Sirturo scored an accelerated approval from the FDA in 2012, becoming the first tuberculosis med to offer a novel mechanism of action in more than 40 years. Since then, the drug has become a staple of worldwide tuberculosis treatment and is listed in the World Health Organization’s recommended treatment guidelines. Earlier this week, regulators in the U.S. and Europe granted Sirturo full approvals, converting their prior conditional approvals.