Orchid Pharma, a subsidiary of Dhanuka Labs based in India, has secured a sublicense for the production of cefiderocol, an antibiotic aimed at enhancing global healthcare accessibility. Cefiderocol is specifically designed to combat Gram-negative bacterial infections that have developed resistance to other antibiotics. Its noteworthy attributes include receiving approval from the US FDA in 2019 and subsequent clearance from the European Medicines Agency in 2020. Furthermore, its significant inclusion on the World Health Organization’s (WHO) Model List of Essential Medicines highlights its essential role in healthcare.
This accomplishment is the result of a partnership between two influential organizations: the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative. Their joint endeavors, which began in 2022, are primarily geared towards guaranteeing widespread access to this antibiotic for populations in low- and middle-income countries.
Manish Dhanuka, the Managing Director of Orchid Pharma, emphasized the company’s expertise in cephalosporin production, which uniquely positions them to manufacture cefiderocol efficiently, making it both cost-effective and quality-assured. This initiative aims to address the healthcare needs of the masses in developing nations, where the challenge of antimicrobial resistance is escalating.
As part of their agreement, Orchid Pharma is obliged to seek product approval and evaluation from WHO’s medicines pre-qualification program. Participation in this program grants products eligibility for an expedited registration process, streamlining the national approval procedures.
The Looming Threat of Antimicrobial Resistance (AMR)
- Study in The Lancet: AMR linked to at least 1.27 million deaths in 2019.
- WHO projections: Without interventions, over 10 million lives yearly at risk due to AMR by 2050.
Antimicrobial resistance (AMR) poses a significant threat to public health, with a study published in The Lancet attributing at least 1.27 million deaths to AMR in 2019. Alarming projections from the WHO suggest that without effective interventions, over 10 million lives per year could be at risk due to AMR by 2050.
Notably, the development of cefiderocol was a collaborative endeavor between Shionogi and GSK. Remarkably, the British pharmaceutical giant, GSK, has chosen to waive its royalties from the sales of this medication in low- and middle-income countries.
