• Meropenem resistance in India is as high as 62-87%, with up to 50% linked to MBL prevalence, according to ICMR report
• India faces a significant burden of MBL-producing pathogens in hospital settings, and no approved MBL inhibitors currently exist in the country

India, February 25, 2025: Venus Remedies Ltd. (NSE: VENUSREM, BSE: 526953), a leading Indian pharmaceutical company renowned for its longstanding expertise in combatting antimicrobial resistance (AMR), today announced that it has entered into an exclusive license agreement with Infex Therapeutics, a UK-based anti-infectives specialist for the clinical development of MET-X. This agreement authorizes Venus Remedies to spearhead the clinical development, registration, and commercialization of MET-X, an innovative metallo-beta-lactamase (MBL) inhibitor. The initial development phase will focus on integrating MET-X with meropenem to tackle drug-resistant Gram-negative bacteria, with Venus Remedies holding exclusive marketing rights within India.

In India, meropenem resistance is reported to be as high as 62-87% in WHO critical priority pathogens like K. pneumoniae and A. baumannii as per the ICMR’s Antimicrobial Resistance Research and Surveillance Network-Annual report 2023, with as high as 50% being directly attributable to MBL prevalence.

Under the terms of the agreement, Venus Remedies will commence with a Phase I trial involving healthy volunteers in India, evaluating MET-X in combination with meropenem. Following successful Phase I outcomes, the focus will shift to Phase II/III trials targeting drug-resistant Complicated Urinary Tract Infections (cUTIs), prevalent in hospital settings.

This strategic move is aligned with Venus Remedies’ extensive experience in antibiotic R&D and critical care, enhancing its leadership in the Indian critical care landscape. The company’s formidable position in meropenem marketing and manufacturing will facilitate the integration of MET-X into existing and prospective antibiotic strategies.

All trials conducted in India will adhere to international standards, compliant with regulations from the FDA, EMA, and MHRA, which will also support further development and global commercialization efforts for MET-X. The agreement grants both Infex Therapeutics and Venus Remedies the option to expand their collaboration to include other MET-X/beta-lactam combinations under mutually agreed terms.

MET-X is Infex Therapeutics’ broad spectrum MBL-inhibitor, targeting Gram-negative bacteria. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics, such as meropenem, and evade antibiotic clearance of disease. MET-X blocks MBL resistance, restoring antibiotic activity. The drug is being developed to be one of the first broad-spectrum MBL inhibitors to address a wide range of bacterial species and MBL-resistant strains, such as E.coli and K.pneumoniae. The treatment has shown best-in-class performance in animal studies to date. The development of new agents to overcome MBL antibiotic resistance in such Gram-negative bacteria is a World Health Organisation (“WHO”) critical priority.

Mr. Saransh Chaudhary, President, Global Critical Care, Venus Remedies Ltd and CEO, Venus Medicine Research Centre, said: “This early-stage introduction of MET-X into the Indian market leverages our decades-long dedication to AMR-focused R&D and our prominent role in critical care and antibiotic therapies. This partnership is perfectly poised to enhance our antibiotic arsenal with meropenem and explore further beta-lactam combinations, ensuring high-quality research and a significant market presence.”

Mr. Pawan Chaudhary, Chairman and Managing Director, Venus Remedies Ltd, added, “The in-licensing of MET-X is a major step forward in providing breakthrough solutions for drug-resistant infections, a serious threat to India’s healthcare ecosystem. Our aim is to develop an effective solution against MBL-producing pathogens, fulfilling a critical healthcare need and continuing our commitment to transformative therapies and sustained innovation in critical care.”

India faces a significant burden of MBL-producing pathogens in hospital settings, and no approved MBL inhibitors currently exist in the country. The development and exclusive in-licensing of MET-X underscores Venus Remedies’ commitment to providing a cutting-edge solution where it is needed most and creating long-term value for stakeholders.

Dr. Peter Jackson, CEO of Infex Therapeutics, said: “I am delighted about this agreement with Venus Remedies, which will facilitate the comprehensive clinical development of our MET-X program in India. By leveraging Venus Remedies’ robust expertise in critical care antibiotics, we can accelerate MET-X as our second clinical-stage drug program. Crucially, the international standards of these trials will also support future regulatory filings in the UK, U.S., Europe, and other global markets. MET-X has shown best-in-class performance in preclinical studies and could be game-changing for patients suffering from Gram-negative, MBL-resistant infections.”

About Venus Remedies Ltd (venusremedies.com)

Panchkula-based Venus Remedies Ltd (NSE: VENUSREM, BSE: 526953) is among the 10 leading fixed-dosage injectable manufacturers in the world. Having a commercial presence in 90+ countries with a portfolio of 75 products spread over Europe, Australia, Africa, Asia-Pacific, Commonwealth States, the Middle East, Latin America and the Caribbean region, the company has nine globally benchmarked facilities in Panchkula, Baddi and Werne (Germany), apart from 11 overseas marketing offices. The company holds the GMP approvals from European- GMP (INFARMED), PIC/S (Malaysia & Ukraine), SAHPRA, UNICEF, TGA, INVIMA & WHO-GMP, alongside key ISO certifications for quality, environmental, and occupational health and safety management.

Central to its mission, Venus Remedies is a frontrunner in combating antimicrobial resistance (AMR) through its dedicated research division, Venus Medicine Research Centre (VMRC). The company is pivotal in developing advanced antibiotics and β-lactam/β-lactamase inhibitor combinations aimed at tackling multidrug-resistant pathogens. Its notable initiatives like GASAR provide essential data on antibiotic resistance, while the PLEA Trust fosters antibiotic stewardship. As an influential member of the AMR Industry Alliance, India AMR Innovation Hub, and Vivli AMR Registry, Venus Remedies shapes global AMR research and policy. Through strategic collaborations with academic and health organizations worldwide, the company enhances AMR surveillance and supports innovative drug development, affirming its leadership in global healthcare.

About Infex Therapeutics (www.infextx.com)

Infex Therapeutics Holdings plc is a leader in critical-priority infectious diseases, with a broad and diverse pipeline of innovative best-in-class and first-in-class drug candidates to address the urgent global shortage of novel anti-infective treatments. The Company is building a differentiated pipeline through in-house drug discovery, acquisition, co-development and in-licensing of early stage/pre-clinical candidates, developing them to clinical proof of concept before licensing to commercial pharma partners.