WHO Reports Reveal Weak Pipeline for Antibiotic Agents

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

Last week, the World Health Organization (WHO) issued two reports suggesting that declining private investment and lack of innovation in the development of new antibiotics is undermining efforts to combat drug-resistant infections.  The WHO reports address fifty antibiotics (and ten antibacterial biologics) that are currently in clinical and preclinical development (see "Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline" and "Antibacterial agents in preclinical development").  However, the WHO reports indicate that these compounds "bring little benefit over existing treatments and very few target the most critical resistant bacteria (Gram-negative bacteria)."

The Director-General of WHO, Dr. Tedros Adhanom Ghebreyesus, noted that "[n]ever has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent," adding that "[n]umerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines."  WHO also pointed out that research and development for antibiotics is primarily driven by small- or medium-sized enterprises, and that large pharmaceutical companies continue to exit the field of antibiotic research.

With respect to its review of the clinical development of antibiotic agents, WHO noted that of the fifty antibiotics in the pipeline, 32 target pathogens that appeared on WHO's 2017 list of priority pathogens, but that the majority of antibiotics in clinical development have limited benefits when compared to existing antibiotics.  In addition, only two of the fifty antibiotics are active against multi-drug resistant Gram-negative bacteria, which WHO indicated are spreading rapidly and require urgent solutions.  The WHO report also highlights a "worrying gap in activity" against NDM-1 (New Delhi metallo-beta-lactamase 1), an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics.  According to the WHO report, there are only three antibiotics in the pipeline that can be used to treat resistant bacteria expressing NDM-1 (often referred to as "superbugs").  As for its review of the preclinical development of antibiotic agents, the WHO report suggests that an optimistic scenario is for the first two to five products to become available in about 10 years.

WHO Assistant Director-General for Antimicrobial Resistance, Hanan Balkhy, stated that "[i]t's important to focus public and private investment on the development of treatments that are effective against the highly resistant bacteria because we are running out of options."  WHO also noted that with respect to antibiotic research and development, WHO and the Drugs for Neglected Diseases Initiative (DNDi) have established the Global Antibiotic Research and Development Partnership (GARDP), a non-profit research and development organization that is working with more than fifty public and private sector partners in twenty countries to accelerate the development of new and improved antibiotics to tackle drug-resistant infections.  GARDP's goal is to deliver five new treatments by 2025.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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