Latest news with #Acinetobacterbaumannii
Euractiv
2 days ago
- Health
- Euractiv
Last-resort antibiotic excluded from Belgian system, testing EU pharma reforms
A critical antibiotic designed to treat infections caused by multidrug-resistant bacteria will remain unavailable through Belgium's reimbursement system after negotiations between the government and the manufacturer failed. The problem goes far beyond Belgium. The inability to secure access to cefiderocol reflects a broader European market failure in valuing and funding last-resort antibiotics. 'The fight against antimicrobial resistance (AMR) is a spearhead of your policy and was a priority during the recent Belgian EU presidency,' MP Irina De Knop (Open VLD) told Health Minister Frank Vandenbroucke in the Belgian Parliament on 15 July, addressing the issue. 'The challenge lies not only in preventing resistance but also in ensuring access to scarce, new antibiotics that serve as last-resort treatments.' First-in-class antibiotic Cefiderocol is not a generic antibiotic. It is a first-in-class, patented siderophore cephalosporin developed by Shionogi, approved in the EU in 2020 under the name Fetcroja®. Specifically engineered to treat carbapenem-resistant Gram-negative bacteria such as Acinetobacter baumannii and Pseudomonas aeruginosa , it penetrates bacterial defences by hijacking iron uptake pathways. Its novel mechanism and limited target population make it difficult to assess using traditional volume-based pricing and reimbursement models designed for high-volume generics. Cefiderocol targets 'superbugs' identified by the World Health Organisation (WHO) as priority pathogens and is intended for an estimated 200 patients per year in Belgium, typically those with no remaining treatment options. 'Precisely because of this limited target group, it is hardly commercially viable,' said De Knop. 'The societal value of reserve antibiotics lies not in frequent use, but in their availability. This leads to a 'broken market' that threatens innovation and sustainable access.' Cost and safety criteria Minister Vandenbroucke confirmed that Belgium's reimbursement process for cefiderocol ended without a deal. 'We went far to reach an agreement, especially for those 55 patients,' he said. 'But apparently, even with far-reaching proposals, we could not meet the company's demands. The requested price is more than double that of the most expensive reimbursed late-line antibiotic.' Citing limited clinical evidence and safety concerns from one comparative trial, the minister explained that the antibiotic is classified as a true last-line option and must be kept outside the hospital's regular reimbursement system due to its high cost. 'In the absence of strict prescription controls, there's a risk it would be used too broadly, potentially accelerating resistance to this last-resort treatment,' he warned. While Belgium is monitoring EU-level initiatives, including push and pull incentives and alternative financing mechanisms, the minister acknowledged: 'There are currently no concrete plans to introduce a subscription financing model like in the United Kingdom.' Company calls for pan-European rethink The product's manufacturer, Shionogi, told Euractiv that Belgium's decision reflects a systemic issue across Europe. 'Reserve antibiotics play a vital role in treating infections caused by multidrug-resistant (MDR) pathogens, often when no other options remain,' the company said. 'Although used in very small patient populations, these antibiotics offer immense public health value, yet current reimbursement systems are not designed for low-volume, high-importance medicines.' The company cited remarks made by Minister Vandenbroucke during an AMR conference held under the Belgian Presidency of the Council in June 2024: 'Look at antibiotics: they should not be used too much. However, some of them have to be ready as soon as you need them. For that, you need a different kind of financing, almost like a subscription to a streaming service.' 'These initiatives, including the 'streaming service' model referenced by Minister Vandenbroucke, are aligned with G7 health priorities and show how sustainable innovation and access can go hand in hand,' the company said. Shionogi confirmed participation in delinked funding pilots: 'Yes. Shionogi is actively participating in the UK's NHS AMR Subscription Model, which pays for antibiotics based on their value to the health system, not the volume used. We were also involved in Sweden's national pilot and are engaged in discussions with HERA on similar approaches.' 'We recognise that European countries have unique needs. In Belgium, as across Europe, we're always open to solutions that deliver timely access for patients, reward responsible use, and make continued innovation in antibiotics possible,' the company's CEO Huw Tippett told Euractiv. A test case for the EU's Pharmaceutical Package Despite Belgium's efforts to strike a deal, MP De Knop warned that the lack of reimbursement leaves patients at risk. 'The result remains that this antibiotic, which is particularly important for a small group of people, is currently not reimbursed,' she said. 'You also did not present an immediate solution,' pointing to the minister. Belgium plans to introduce 'early and fast access' procedures by 2026, but currently lacks a dedicated funding stream for reserve antimicrobials. With no viable market and limited public procurement tools, cefiderocol has become a test case for Europe's broader pharmaceutical policy agenda. Antibiotic incentives are central to the EU's Pharmaceutical Package, currently under negotiation. The European Commission has proposed transferable exclusivity vouchers and pull incentives to stimulate antimicrobial innovation, though these remain politically contentious. Under the Belgian Council Presidency in June 2024, EU health ministers adopted Council conclusions calling on the European Commission and Member States to 'explore alternative reimbursement models, such as subscription-based schemes,' and to strengthen 'EU-level coordination to ensure sustainable access to critical antimicrobials.' These conclusions were part of the strategy paper 'The Future of the European Health Union: a Europe that cares, prepares and protects.' While often associated with generic shortages, the proposed Critical Medicines Act also introduces tools such as joint procurement, strategic stockpiling, and EU-wide demand coordination, all of which could be applicable to patented, last-resort antibiotics like cefiderocol. [Edited by Vasiliki Angouridi]
Malaysian Reserve
04-07-2025
- Business
- Malaysian Reserve
Brii Biosciences Announces Licensing Agreement with Joincare Group for Rights to BRII-693 in Greater China
Joincare Group to lead the clinical development and commercialization of BRII-693 in Greater China Brii Biosciences retains ex-Greater China rights to address the global antimicrobial resistance threats and continues investment in other priority pipeline assets DURHAM, N.C. and BEIJING, July 3, 2025 /PRNewswire/ — Brii Biosciences Limited ('Brii Bio,' stock code: a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs, today announced that it has entered into a license and technology transfer agreement with Joincare Pharmaceutical Group Industry Co., Ltd ('Joincare Group'). Joincare Group will obtain an exclusive license from Brii Bio for the research, development, and commercialization of BRII-693 in the Greater China region. Under the terms of the agreement, Joincare Group will assume full responsibility for the development, regulatory approval and commercialization of BRII-693 in Greater China. In return, Brii Bio has received an upfront payment and will receive additional development and commercial milestone payments upon certain future milestone events plus tiered royalties on net product sales. BRII-693 is a novel synthetic lipopeptide in development for the treatment of critically ill patients with multidrug- and extensively drug-resistant (MDR/XDR) gram-negative bacterial infections, particularly those caused by carbapenem-resistant Acinetobacter baumannii (CRAB), Pseudomonas aeruginosa (CRPA) and Enterobacterales (CRE). Discovered through iterative structural modifications of the polymyxin scaffold, BRII-693 was designed to enhance antibacterial potency while reducing the toxicity commonly associated with older polymyxin agents such as renal and neuro-toxicities. In phase 1 studies, BRII-693 demonstrated a favorable safety, tolerability, and PK profile in healthy non-Chinese and Chinese participants. Brii Bio received IND approval from CDE of NMPA for a Phase 1 PK bridging study in China supporting a future Phase 3 registrational trial in patients with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio, commented: 'The growing threat of antimicrobial resistance in Greater China underscores the urgency for novel hospital antibiotics. With Joincare Group's proven capabilities in manufacturing and commercializing hospital antibiotics, we found the ideal partner to accelerate the development and commercialization of BRII-693. This partnership enables us to deliver a critical care medicine to Chinese patients facing life threatening infections.' Mr. Nanqi Lin, Chief Executive Officer of Joincare Group, stated, 'The Company has a long-standing track record of excellence in innovative drug research and development, underpinned by deep scientific expertise and a robust R&D platform. Driven by Brii Bio's well-established R&D system, the BRII-693 project demonstrated strong innovation and scientific rigor. Early data showing encouraging results in terms of therapeutic potential, pharmacodynamics, and pharmacokinetics, suggesting BRII-693's high potential to become a best-in-class therapy to address the critical unmet clinical needs. We are confident in the clinical prospects of BRII-693. This collaboration further strengthened Joincare Group's strategic positioning in the anti-infection disease area. We look forward to launching this asset soon, providing patients with more high-quality treatment options.' About BRII-693 BRII-693 is a novel synthetic lipopeptide in development for the treatment of critically ill patients with MDR/XDR gram-negative bacterial infections, especially carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa. Brii Bio holds exclusive global rights to develop and commercialize BRII-693. About Brii Bio Brii Biosciences Limited ('Brii Bio', stock code: is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit About Joincare Group Established in 1992, Joincare Group (Joincare Pharmaceutical Group Industry Co., Ltd) is an innovative scientific research-based integrated pharmaceutical group after many years of steady operation and rapid development. The group owns two major listed companies, Joincare and Livzon Pharmaceutical, as well as more than 20 major holding subsidiaries. The company has always adhered to the concept of scientific and technological innovation as the cornerstone, implementing a dual-driver strategy focused on innovative drugs and high-barrier complex formulation technology platforms, and has carried out rich pipeline layouts around respiratory, anti-infective, gastrointestinal, assisted reproduction, psychiatric, oncology and other areas of significant clinical needs, forming a rich and diversified product matrix and pipeline of drugs under development. Forward-looking Statements This contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
Arabian Post
12-06-2025
- Health
- Arabian Post
Breakthrough Antibiotic to Combat Deadly Superbug Advances
Swiss pharmaceutical firm Roche has advanced its antibiotic candidate, zosurabalpin, into Phase 3 clinical trials, representing a potential landmark in the fight against Gram-negative bacterial infections. Targeting carbapenem-resistant Acinetobacter baumannii, the drug could mark the first approval of a novel antibiotic class in more than 50 years. Zosurabalpin, a tethered macrocyclic peptide developed in collaboration with Harvard University, disrupts the outer lipopolysaccharide membrane essential for bacterial survival. Early-stage studies demonstrated favourable safety and pharmacokinetic profiles, while animal models of lung and thigh infections caused by CRAB confirmed its therapeutic potential. Roche anticipates enrolling approximately 400 hospitalised patients worldwide in the upcoming trial round, with the aim of comparing zosurabalpin directly against current standard-of-care antibiotics. The urgency of this development is underscored by CRAB's classification by the US Centers for Disease Control and Prevention as an 'urgent threat' and by the World Health Organization as a high priority pathogen. Infection fatality rates hover around 40–60%, particularly among immunocompromised patients such as those in intensive care. Existing antibiotics are often ineffective due to CRAB's robust outer membranes that thwart drug penetration. ADVERTISEMENT Phase 3 trials are scheduled to begin late this year or in early 2026, spanning over 100 global sites and aiming for regulatory submission by the decade's end. Roche executives emphasise that approval would not only address a dire clinical need but also serve as a catalyst for renewed antibiotic research, especially against Gram-negative organisms. 'Finding new classes is very hard,' noted Michael Lobritz, Roche's global head of infectious diseases; approval could lay groundwork for future innovation. Roche has previously stepped back from antibiotic R&D, but a reinvestment around ten years ago has now yielded zosurabalpin. The firm is simultaneously exploring additional novel compounds, including a LepB inhibitor targeting carbapenem-resistant Gram-negative pathogens in urinary tract infections. Efforts to restore antibiotic pipelines have gained traction from policymakers. The UK introduced a subscription-style payment model to support antimicrobial development, decoupling revenue from volume to ensure steady returns. The US is now considering similar incentives. Such frameworks aim to overcome financial disincentives that have plagued the industry, contributing to the closure of many smaller biotechs focusing on antibiotics. Meanwhile, complementary research is underway. A novel molecule named lariocidin was identified from soil bacteria by scientists at McMaster University. It targets the bacterial ribosome through a distinctive lasso-peptide structure but remains in preclinical stages. Similarly, researchers at MIT and McMaster have used artificial-intelligence methods to develop abaucin, a narrow-spectrum compound effective in killing CRAB. Both discoveries offer hope for expanding the antibiotic pipeline beyond zosurabalpin. Zosurabalpin's mechanism of action—from inhibiting lipopolysaccharide transport to compromising the bacterial envelope—distinguishes it from older therapies, which have often been broad-spectrum and prone to fostering resistance. By contrast, this new agent is narrow-spectrum, tailored to CRAB and avoiding pre-existing resistance mechanisms. The evolving antibiotic landscape now features roughly 20 candidates in clinical development for high-priority pathogens, though historical attrition rates remain troubling. Financial instability has led to the collapse of several promising antibiotic-focused firms, exemplified by Achaogen's bankruptcy in 2019 shortly after FDA approval of plazomicin. In light of these challenges, zosurabalpin represents a critical test case: its success could prove the viability of targeted, high-impact antibiotic development supported by improved economic incentives. As Roche and its collaborators gear up for the pivotal Phase 3 trial, global health advocates view the outcome not only as a potential therapeutic breakthrough, but as a signal of renewed momentum in a sector long plagued by stagnation.
India Today
27-05-2025
- Health
- India Today
Antibiotic for deadly superbug behind hospital infections enters final trials
A new drug that could help combat one of the world's most dangerous drug-resistant bacteria is now entering its final stage of human trials. This potential breakthrough could help in the global fight against antibiotic pharmaceutical giant Roche announced on Monday that its experimental antibiotic, zosurabalpin, developed in collaboration with Harvard University, is moving into phase 3 final phase will test the drug on around 400 patients worldwide, focusing on its ability to treat infections caused by Acinetobacter baumannii, a bacteria known to cause severe hospital-acquired infections like pneumonia and Acinetobacter baumannii is a short, rod-shaped, gram-negative bacterium. Scientists call it an "opportunistic bacterial pathogen" as it affects people with weak immune systems, highly present in hospital baumannii has been recognised as an "urgent threat" by the US Centers for Disease Control and Prevention (CDC), and has become increasingly resistant to existing no new antibiotics targeting this superbug have been developed in over five decades. Swiss pharmaceutical giant Roche announced on Monday that its experimental antibiotic, zosurabalpin, developed in collaboration with Harvard University, is moving into phase 3 trials. () What sets zosurabalpin apart is that it works in a new way, using a mechanism that bacteria haven't yet found a way to resist. This fresh approach brings new optimism to a field where many treatments are failing due to antibiotic caused by drug-resistant bacteria are not only difficult to treat but also widespread. Globally, sepsis is estimated to cause 11 million deaths a year, while community-acquired pneumonia (CAP) kills 3 to 4 million people annually, especially among the elderly."Antimicrobial resistance is one of the biggest infectious disease challenges to public health. Our goal is to contribute new innovations to overcome this growing threat.',' said Michael Lobritz, Roche's global head of infectious diseases, told The Tsai, head of immunology and product development at Roche's US unit Genentech, added that Acinetobacter baumannii is present in every country. He added that the unique biology involved in developing zosurabalpin might even lead to future discoveries in the fight against other resistant phase 3 trial will compare the effects of zosurabalpin to current standard treatments, and if successful, the drug could be ready for approval by the end of this decade.
Irish Independent
27-05-2025
- Health
- Irish Independent
First new antibiotic in 50 years could help treat superbug labelled ‘urgent threat'
The drug, which targets one of the bacteria considered to pose the biggest threat to human health, has been hailed as an 'exciting' development in the fight against antibiotic resistance. Yesterday, Roche, the Swiss pharmaceutical giant, announced it will take zosurabalpin into the third and last phase of testing on humans. It is the first drug in five decades to show promise of tackling Acinetobacter baumannii, a pathogen which is described as a 'priority' by the World Health Organisation and an 'urgent threat' by the Centres for Disease Control and Prevention, the US national public health agency. The drug-resistant bacteria disproportionately impact patients who are in the hospital, causing infections such as pneumonia and sepsis. It is estimated that between 40pc and 60pc of infected patients, many of whom are immunocompromised because of conditions such as cancer, die as a result of the bug. One of the reasons it is so difficult to treat is that it has a double-walled 'membrane' protecting it from attack, so it is difficult to get drugs into it and to keep them in, experts said. Zosurabalpin, which has been developed alongside researchers at Harvard University, targets the 'machine' which stops the outer membrane from forming properly. It works differently to all existing antibiotics and it is hoped that it could lay the foundations for future drugs. 'Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health,' Michael Lobritz, global head infectious diseases at Roche, said. The phase-three trial, which it is hoped will start later this year or in early 2026, will look at around 400 patients with a carbapenem-resistant Acinetobacter Baumannii (Crab) infection who will either receive zosurabalpin or the current standard of care. It is hoped that the drug will be approved by the end of the decade. Pharmaceutical companies have in the past been unwilling to pursue new antibiotics because of a difficult market in which the drugs are used sparingly to try and avoid resistance. However, the UN has warned that if nothing is done to address the issue, drug-resistant diseases could cause 10 million deaths each year by 2050.
