In a move that aims to address the unmet needs of patients across low-and middle-income countries where antimicrobial resistance is spreading fast, India based drug manufacturer, Orchid Pharma Ltd has inked a pact with the WHO-constituted Global Antibiotic Research & Development Partnership (GARDP) to manufacture cefiderocol, an antibiotic to treat certain Gram-negative infections.
Gram-negative bacteria cause infections including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis in healthcare settings. Gram-negative bacteria are resistant to multiple drugs and are increasingly resistant to most available antibiotics. To tackle these growing threats, Cefiderocol was approved by the US Food and Drug Administration in 2019 and the European Medicines Agency in 2020, and it is on the WHO Model List of Essential Medicines. GARDP was created by the WHO and Drugs for Neglected Diseases initiative (DNDi) in 2016 to ensure developing new treatments for drug-resistant infections that pose the greatest threat to health.
The agreement is a critical step in an ambitious project by Shionogi & Co. Ltd. (Shionogi), GARDP, and the Clinton Health Access Initiative (CHAI) that aims to provide cefiderocol available in 135 countries (about 70% of countries worldwide, including those with the highest antimicrobial resistance -AMR burden), none of which currently has access. Based on these agreements, CHAI will facilitate the technology transfer process between Shionogi and Orchid Pharma. Shionogi will convey essential information for the manufacture of cefiderocol to Orchid Pharma.
“Manish Dhanuka, Managing Director of Orchid Pharma, one of the world’s leading manufacturers of cephalosporin antibiotics said that this will ensure manufacturing affordable and quality-assured cefiderocol. “Access is one of the least talked about issues in the global AMR crisis. This is not just a global market failure but also a public health failure,” added Manica Balasegaram, Executive Director of GARDP, according to a statement here.
“We can effectively offset the burden of antibiotic resistance by reducing the access gap between high- and lower-income countries so that the right antibiotics are affordable and available for appropriate use...” Orchid was selected following a rigorous vetting process led by CHAI with GARDP. The manufacturing sublicense agreement has important access, environmental, and stewardship provisions, including cost-plus pricing, with a commitment to lower the costs based on volumes to help keep the product affordable for patients and health systems in low-resource settings.
