Reinvigorating Antibiotic R&D?
There has been a growing trend among pharmaceutical and biotech companies to abandon their antibacterial research and development efforts. Big companies like Pfizer, AstraZeneca, Bristol-Myers Squibb, to name just a few, have come to the decision that the potential commercial and financial returns from discovering and developing antibiotics are not worth the investment. Small and mid-sized companies then started to fill this gap, but recently have found it increasingly difficult to justify remaining in this therapeutic area. Last year was a particularly bad year for antibiotic research and development. Disappointingly, 2018 saw the departure of remaining stalwarts Novartis, Sanofi, Allergan, The Medicines Company, Achaogen, and Melinta, leaving the antibiotic R&D space and curtailing development activities.
However, the need for new antibiotics remains high, with drug-resistant bacteria infecting at least 2 million people and killing at least 23,000 people in the U.S. every year, according to the Centers for Disease Control and Prevention (CDC) [1]. Antibiotic resistance is increasing, and the available antibiotic choices for combating these pathogens are dwindling. Since resistance will always develop with antibiotics, novel antibiotics will continually be needed. The more we use them, the less effective they become because bacteria have more opportunities to develop resistance. We need to replenish our antibiotic pipeline now.
“Antibiotic resistance is growing and we are running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time,”
- Dr. Marie-Paule Kieny, WHO’s assistant director-general for health systems and innovation (2)
U.S. and British governments have called for global efforts to tackle antimicrobial resistance (AMR). As a result of the void created by pharmaceutical companies no longer filling the antibiotic pipeline, programs to incentivize antibiotic research have been created. Programs such as CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), Wellcome Trust (a London-based global biomedical research charity), the Bill and Melinda Gates Foundation, and BARDA (Biomedical Advanced Research and Development Authority) have been funding discovery, research, and development efforts for antibiotics. Traditional venture capital firms, like Novo Holdings, launched the REPAIR Impact Fund in 2018, with a budget of $165 million to invest in companies focused on developing treatments for drug-resistant infections. The economic model that once meant we could rely on the pharmaceutical industry for a steady supply of new antibiotics simply no longer works. New economic frameworks and increased investment are needed to drive antimicrobial innovation.
CARB-X is one of the world’s largest public-private partnerships dedicated to early-stage antibiotic discovery and pre-clinical development. They have seven partners in the United States and United Kingdom and are backed with half a billion dollars in funding (their partners include BARDA and Wellcome Trust). Their goal is to set up a diverse portfolio with more than 20 antibacterial products and move at least 2 of them into human clinical trials. Projects they fund are in the early development and pre-clinical stage, with an emphasis on discovering new antibiotics against multi-drug resistant bacteria.
“The world urgently needs new antibiotics, vaccines, diagnostics and other products to help fight the rise of drug resistant bacteria. If we fail to solve this problem, many advances of modern medicine that depend on fighting infection with antibiotics – routine surgery, cancer therapy, treatment of chronic diseases – may be jeopardized.”
– Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) (3)
For their part, the FDA created the designation of Qualified Infectious Disease Product (QIDP), which includes several regulatory and commercial incentives for antibiotics that meet certain criteria. These incentives include eligibility for priority review, fast track designation, and a five-year extension of market exclusivity [4]. The EMA (European Medicines Agency) is exploring “adaptive pathways” for high-need areas in which current care is unsatisfactory [5]. Both the FDA and EMA have been flexible about the totality of evidence required for approval. Recent approvals for some anti-infectives were based on one randomized, controlled Phase 3 trial and a small open-label, single-arm study in a population of high unmet need (instead of being required to conduct large, randomized, controlled Phase 3 trials).
Is enough being done to reinvigorate the antibiotic industry? The next few years will prove to be very important as the new economic and incentive models play out. Commercial successes for recently launched antibiotics could be the necessary key to bring a new wave of investment back into both the discovery and development spaces.
We at Emery Pharma support the dedicated researchers and companies passionate about reinvigorating antibiotic R&D, and want to be part of the global effort to replenish the antibiotic pipeline. We are a contract research & development lab (CRO) with the capabilities to perform a broad range of microbiological testing services to help in the discovery and development of novel anti-infectives. We offer a full array of microbiology services to characterize the antimicrobial properties of a compound by investigating the minimum inhibitory concentrations (MICs), minimum bactericidal concentrations (MBCs), minimum biofilm eradication concentrations (MBECs), time kill kinetics, synergy effects, spontaneous frequency of mutation rates, development of resistance through serial passage, post-antibiotic effect, as well as cytotoxicity evaluations. For more information about our antimicrobial testing services and R&D capabilities, please contact us online or call us at +1 (510) 899-8814!
About the Author
Originally authored by Dr. Aya Kubo. This article was reviewed and updated on July 24, 2025 by Dr. Janet Liu, current Director of Biology.
References
- About Antimicrobial Research (2018, Sep 10). Center for Disease Control and Prevention. Retrieved from https://www.cdc.gov/antimicrobial-resistance/about/.
- WHO Publishes List of Bacteria for Which New Antibiotics are Urgently Needed (2017, Feb 27). World Health Organization. Retrieved from https://www.who.int/en/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed.
- A Global Solution to a Growing Threat (N/A). Carb-X, Combatting Antibiotic Resistant Bacteria. Retrieved from https://carb-x.org/about/overview/.
- Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review (2018, Feb 23). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/ForPatients/Approvals/Fast/default.htm.
- Adaptive Pathways (2015, Nov 20). European Medicines Agency. Retrieved from https://www.ema.europa.eu/en/human-regulatory/research-development/adaptive-pathways.
