Cefepime hydrochloride

ALLSCHWIL, Switzerland I August 14, 2025 I Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an exclusive license agreement with Venatorx Pharmaceuticals, Inc., to acquire the global rights to ceftibuten-ledaborbactam etzadroxil, a clinical phase 3-ready oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for the potential treatment of complicated urinary tract infections (cUTI), including pyelonephritis. Ceftibuten-ledaborbactam etzadroxil is the combination of ceftibuten, an orally bioavailable cephalosporin antibiotic, and ledaborbactam etzadroxil, the orally bioavailable prodrug of the novel beta-lactamase inhibitor ledaborbactam. The combination demonstrates bactericidal activity against Enterobacterales, including multidrug-resistant pathogens, the major cause of cUTI. [1] In the USA, cUTI account for more than 600,000 hospital admissions each year. [2] This underscores the significant clinical burden and need for effective oral treatment options, which may shorten or entirely avoid hospitalization. In preclinical and clinical phase 1 studies, ceftibuten and ledaborbactam etzadroxil were shown to be safe and well tolerated. [3] David Veitch, Chief Executive Officer of Basilea, said: “This agreement allows us to strengthen our late-stage clinical pipeline and supports our strategy of ensuring that we have a continuous stream of potential new product launches in the near-term future, positioning us for sustainable substantial revenue growth. Ceftibuten-ledaborbactam etzadroxil holds strong promise in addressing the critical unmet need for the oral treatment of cUTI caused by multidrug-resistant Gram-negative bacteria and represents a compelling global commercial opportunity. We expect starting a registrational phase 3 program in cUTI in about 18 months.” Under the terms of the agreement, Basilea will make an upfront payment and potential milestone payments in 2025. Following the successful completion of the phase 3 clinical development program and after the grant of regulatory approval and start of commercialization, Venatorx is eligible to receive tiered mid-single-digit royalties and additional potential milestone payments of up to USD 325 million in total, if all agreed commercial milestone events are triggered over the term of the contract. The transaction is expected to result in approximately CHF 15 million of additional research and development expenses in 2025, including the full upfront payment, all potential pre-commercial milestone payments and expected R&D expenses in 2025. Basilea will provide updated financial guidance for the full-year 2025, reflecting this transaction, with the half-year earnings report on August 19, 2025. About beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections by multidrug-resistant bacterial pathogens. About ceftibuten-ledaborbactam etzadroxil Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales. [4] Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. About complicated urinary tract infections (cUTI) Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options. [1] Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx also developed cefepime-taniborbactam, an intravenous-only antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. The ceftibuten-ledaborbactam etzadroxil project has been funded in whole or in part with Federal funds from National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201600029C and the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00050. For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com . About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com . References SOURCE: Basilea

Mumbai: Wockhardt is working on ambitious plans for Zaynich , a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of ’26. In the US, it plans to file for regulatory clearance in August.“We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,” Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for. “We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,” Khorakiwala said. “One option is licensing out, the other is in some markets like in India we are doing ourselves,” he said. “The US is another market where we are thinking of the possibility (of marketing on its own); you don’t need too much marketing cost and you have talent available.” Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part. “For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,” said Khorakiwala. “Zaynich — we are manufacturing everything in Europe.” It will adopt the same strategy to outsource most of the manufacturing for all its other new products. The company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. “That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,” he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. “We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,” said Khorakiwala. He also stressed on the company’s focus on biologics as another key growth driver. “Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,” he said. Wockhardt does not see itself as a generic company, he said. “In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,” he said. The chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said. By Rica Bhattacharyya ,