Amoxicillin/Clavulanate Potassium

PHILADELPHIA--(BUSINESS WIRE)--Kaizen Biosciences, Co., a biopharmaceutical company, today announced the acceptance of its abstract for presentation at IDWeek 2025, which serves as a premier forum for infectious disease (ID) professionals to knowledge-sharing around improving patient care and overall public health. The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA’s new CNPV program, underscores the significance and urgency of our approach In addition, the company recently presented new pharmacokinetic data at the International Society of Pharmacometrics (ISoP/ISOM) a biennially meeting, spotlighting a novel amoxicillin-reduced clavulanate formulation for use in children aged 3-24 months. The data, presented by Dr. Carl Peck, former Director of the FDA Center for Drug Evaluation and Research (CDER), compared the pharmacokinetics of Augmentin ES-600 with the amoxicillin-reduced clavulanate formulation. The study revealed that Augmentin ES-600 delivered elevated clavulanic acid exposures—exceeding the amount found in adult approved Augmentin formulations, suggesting a need to revisit clavulanate dosing found in the current pediatric approved oral suspension formulations. Dr. Peck further highlighted that the proposed formulation, while containing less clavulanate, still provided the AUC/MIC required for bacterial killing or net bacterial stasis when tested against 5 different H. influenzae strains. Kaizen Biosciences is preparing to submit a New Drug Application (NDA) in September 2025 for its novel amoxicillin-reduced clavulanate formulation. The company is also actively pursuing the FDA’s recently announced Commissioner’s National Priority Voucher (CNPV) Program, which is designed to accelerate review periods. Kaizen intends to formally request consideration under this pathway, highlighting the public health need for an optimized antibiotic and beta-lactamase inhibitor for children aged 3–24 months, while also supporting increased domestic drug manufacturing—a hallmark of national security. “We’re excited to share this important data with the medical and regulatory communities and we remain committed to pursuing our company philosophy of ‘Change, For the Better,’” said Keith-Harrison Dewedoff, Co-Founder & Executive Chair. “The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA’s new CNPV program, underscores the significance and urgency of our approach.” About Kaizen Biosciences Kaizen Biosciences is a clinical-stage biotechnology company focused on serving patients in a variety of therapeutic areas where big, traditional pharmaceutical companies often overlook. The company’s lead program is an improved amoxicillin-clavulanate formulation which reduced the unnecessary quantities of clavulanic acid in children aged 3–24 months while remaining efficacious against S. pneumoniae, H. influenzae, or M. catarrhalis pathogens. For more information, visit: www.kaizenbiosciences.com

Mumbai: Glycomet , Ecosprin and Roseday are medicine brands familiar to millions of patients of diabetes or heart condition in India. But not much is known about Leena Tewari , the reclusive chairperson of USV , the Mumbai-based drugmaker that sells those drugs, among many others. Tewari's name bounced into news and social circles after she purchased two sea-facing luxury duplex apartments in Mumbai's upscale Worli area for a whopping Rs 639 crore, making it the country's costliest residential property. ET broke the news online on the evening of May 28. This transaction shook the property market observers, financial circles, and public at large as it set a record for the most expensive deal concluded in India ever. At over Rs 2.83 lakh per sq ft on carpet basis, the record-breaking deal involves a total area of 22,572 sq ft, spanning the 32nd to 35th floors of a 40-storey super-premium tower overlooking the Arabian Sea on Worli Sea Face. That's not all. Tewari paid over Rs 63.9 crore towards stamp duty and the Goods & Services Tax alone for the registration of the transaction. After accounting for these charges, she has paid a total of nearly Rs 703 crore for the deals. Tewari's stealth move to buy the plush property resonates remarkably with her demeanour. Few may even know that Leena Tewari is among the closest friends of Nita Ambani. Her husband Prashant Tewari, MD at USV, has a similar temperament and is mostly seen as a quiet and long-term strategic thinker. She is among India's richest women, with Forbes estimating her current net worth at $3.9 billion. For decades, the family-run company has braved fierce competition while many of its peers sold out or took on board private equity players to grow their business, or even went for a public listing to raise funds. However, USV has remained owner-driven and grown its revenues to Rs 4,840 crore in FY24, according to data from Tracxn. Industry executives say Leena Tewari shows no rush and prefers a step-wise approach than stray into risky zones. "She has a core team of 10-12 loyal USV executives to oversee the operations. She has a good sense of timing and does not follow hype," a veteran executive told ET. Her singular focus can be seen from the value of USV's top brands. The anti-diabetes drug Glycomet, for instance, is the second leading product in the Indian pharmaceutical market with sales of Rs 806 crore, ranking next to antibiotic drug Augmentin of GSK, which grossed sales of Rs 820 crore over the last twelve-month period. In blood thinners, USV's Ecosprin and its variants commands a dominant position while Roseday is another popular brand to lower cholesterol in heart patients. But, challenges loom for the future. Glycomet is seeing increasing rivalry from new generation anti-diabetes drugs. USV is looking at a strong position in the insulin business in India. Sources say the company is also keen to develop copies of semaglutide, the material that goes into blockbuster weight-loss brands Ozempic and Wegovy. By Kailash Babar & Vikas Dandekar ,