Declining stock prices caused by low returns on antibiotic research and development have caused companies to abandon antibiotic R&D, putting additional pressure on the few remaining companies focused on drug discovery.
This is according to a statement recently issued by the Infectious Diseases Society of America (IDSA) in which the organization’s officials say that this situation threatens access to critical medicine. It also validates a need for government-led incentives that both reward and support work toward a robust, renewable antibiotic supply.
Their release comes on the heels of an announcement this month by Achaogen, Inc., a biopharmaceutical firm that develops antibacterial agents to address multi-drug resistant infections, that the company is expected to reduce operating expenses by approximately 40 percent.
“The cuts, which can potentially endanger the Achaogen’s ability to manufacture its new antibiotic, a drug approved to treat complicated urinary tract infections, follow previous reductions which already compromise the company’s ability to continue research and development for new antibiotics,” IDSA said.
In order to bolster what the IDSA calls a “fragile antibiotic pipeline,” the society calls for federal interventions that include such programs as:
- New models of reimbursement for antibiotics through the Centers for Medicare and Medicaid Services (CMS) that reflect antibiotics’ high value to society and promotes their appropriate use;
- Transferable exclusivity, allowing companies to transfer up to one year’s worth of a new antibiotic’s exclusivity to a more profitable drug;
- Tax credits to help reduce high antibiotic R&D costs;
- Continued investment in the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) to support antibiotic R&D.
Beyond these recommendations, research published last year in the Journal of Antibiotics suggests that programs to address this antibiotic funding problem often ignore needed international collaboration, risking duplicating efforts and leaving funding gaps in the value chain. In addition, “incentive programs are overly committed to early-stage push funding of basic science and preclinical research, while there is limited late-stage push funding of clinical development.”
Antimicrobial resistance is an international health crisis, and, at the current rate of emergence and spread, it’s expected that 10 million people will die from causes related to it by 2050. Researchers estimate it will result in an economic cost of $100 trillion.
In spite of Achaogen’s announcement of significant reductions to operating expenses, the South San Francisco, Calif.-based biopharmaceutical company has recently partnered with The Pew Charitable Trusts to share data from its discontinued LpxC inhibitor antibiotic research program on Pew’s open-access Shared Platform for Antibiotic Research and Knowledge (SPARK). Scientists around the world will have access to the data free of charge, and it is a significant step forward in the fight against drug-resistant superbugs, according to Pew.
“Sharing our data with SPARK is part of Achaogen’s ongoing commitment to address the antibiotic resistance crisis,” said Blake Wise, CEO of Achaogen. “Even though our LpxC program has ended, the data remain valuable, and we hope that our research will help SPARK users contribute to the discovery of novel antibiotics that can treat Gram-negative infections.”