Inceptua Enhances Medicine Access for Serious Gram-Negative Infections in LATAM

As antimicrobial resistance continues to increase globally, infections caused by drug-sensitive bacteria still claim many lives. A recent study highlights that the ongoing development of drug resistance is inevitable due to the vast populations of pathogens and their exposure to antibiotics. Opportunistic pathogens pose a growing threat to individuals with weakened immune systems, despite being susceptible to current antibiotics according to clinical microbiology tests. These challenges are interlinked and expected to worsen as the global population ages, becomes more densely packed, and faces disruptions such as conflicts, extreme weather, and declining living standards.

In a significant development, the Inceptua Group, a global pharmaceutical service company, has announced the expansion of its Early Access Program for cefiderocol to include eligible patients in Argentina, Chile, Colombia, Guatemala, Mexico, and Panama. This initiative is in collaboration with Shionogi & Co. Ltd. and has received approval from local regulatory authorities. Shionogi will supply US-labeled cefiderocol through the Inceptua Early Access Program on a case-by-case basis for patients outside of clinical trials.

Cefiderocol is a small molecule siderophore cephalosporin antibiotic specifically designed to combat serious gram-negative bacterial infections. It works by penetrating the outer cell membrane of gram-negative bacteria, binding to ferric iron, and being actively transported into bacterial cells. This process enables the antibiotic to reach high concentrations in the periplasmic space, where it inhibits cell wall synthesis.

Although cefiderocol is not yet approved for commercial use in Latin America, it has previously received approvals from the US FDA in 2019, the European Medicines Agency (EMA) in 2020, and the Japanese Ministry of Health, Labor, and Welfare in 2023. Since 2020, Inceptua and Shionogi have collaborated to make cefiderocol available through an Early Access program, starting in Europe and later expanding to Canada and the Asia Pacific region. Nearly 1,000 patients have accessed this antibiotic through the program.

Early Access Programs, also known as expanded access, managed access, compassionate use, and named patient supply, provide a regulated pathway for offering medicines to patients who have limited or no alternative treatment options or have exhausted all available treatments in their country. These programs are critical for patients in urgent need of potentially life-saving medicines that are not yet commercially available.

In the United States, cefiderocol is indicated for patients 18 years and older for treating complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Inceptua Early Access specializes in offering strategic advice, design, facilitation, and implementation of global early access programs, distributing unlicensed and other essential medicines worldwide. They partner with pharmaceutical and biotech companies to provide global access to promising treatments. With offices in eight countries and a comprehensive warehousing and distribution network, Inceptua continues to work towards bringing innovative medicines to patients in need.

In addition to early access programs, Inceptua Clinical Trial Supply offers a range of clinical trial supply services, including comparator sourcing, packaging, labeling, storage, and distribution. With over 25 years of experience and operations spanning Europe, North America, and Asia, Inceptua serves life science companies of all sizes, helping advance medical research and patient care.