Inceptua improves access to medicine for serious gram-negative bacterial infections in LATAM

16 May 2024
www.outsourcing-pharma.com
Drug ApprovalClinical StudyQualified Infectious Disease Product
While antimicrobial resistance is on the rise, a greater number of people still succumb to infections caused by drug-sensitive bacteria.
The study reveals that ongoing development of drug resistance is unavoidable, driven by the large populations of pathogens and their exposure to antibiotics. Furthermore, the researchers say, opportunistic pathogens will continue to endanger patients with weakened immune systems, even if they are susceptible to existing antibiotics according to clinical microbiology tests.
These issues are interconnected and are likely to intensify as the human population ages, becomes more densely packed, and faces disruptions like war, extreme weather events, or a decline in living standards.
Now 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 partnership with Shionogi & Co. Ltd. and approved by local regulatory authorities. Shionogi will supply US-labeled cefiderocol through the Inceptua Early Access Program on a case-by-case basis to patients outside of clinical trials.
“Inceptua is pleased to announce the expansion of this Early Access Program to Latin America to allow physicians the opportunity to access this medicine for use with appropriate patients with certain serious gram-negative bacterial infections,” says Stuart Bell, executive vice president, Inceptua Early Access.
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Cefiderocol is a small molecule siderophore cephalosporin antibiotic developed by Shionogi for treating serious gram-negative infections. It penetrates the outer cell membrane of gram-negative pathogens by binding to ferric iron and being actively transported into bacterial cells. This allows it to reach high concentrations in the periplasmic space, where it inhibits cell wall synthesis.
While cefiderocol is not yet approved for commercial use in Latin America, it has received approval from the US FDA in 2019, the European Medicines Agency (EMA) in 2020, and the Japanese Ministry of Health, Labor, and Welfare in 2023.
Inceptua and Shionogi have collaborated since 2020 to make cefiderocol available through an Early Access program, initially starting in Europe and subsequently expanding into Canada and the Asia Pacific region. To date, nearly 1,000 patients have accessed cefiderocol through this program.
Making medicines available for those with limited options
Early Access Programs, also known as expanded access, managed access, compassionate use, and named patient supply, provide a compliant route for making medicines available to patients who either have limited or no alternative treatment options or have exhausted all other available treatments in their country of residence.
In the US, 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, among others.
Inceptua Early Access offers strategic advice, design, facilitation, and implementation of global early access programs, distributing unlicensed and other medicines worldwide. Partnering with pharma and biotech companies, it has global reach, allowing patients access to potentially life-saving medicines. It has offices in eight countries and a global warehousing and distribution network and continues bringing promising medicines to patients.
Inceptua Clinical Trial Supply provides clinical trial supply services, including comparator sourcing, packaging, labeling, storage, and distribution. With more than 25 years of experience and global operations across Europe, North America, and Asia, Inceptua serves life science companies of all sizes.
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