In an acknowledgment that the world is in serious need of new antibiotics to fight increasingly drug resistant bacteria, US and UK officials have announced a new, multimillion-dollar effort to boost antibiotic research and development.
The public-private partnership, called the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), will provide $44 million this year and as much as $350 million over the next 5 years to restock the R&D pipeline and get new antibiotics from labs into human clinical testing. The partners include the US Department of Health and Human Services (HHS), the Wellcome Trust of London, the newly founded AMR Centre in England, and Boston University School of Law.
With antibiotic resistance increasing, the need for new antibiotics is growing more urgent. According to the Pew Charitable Trusts, nearly all antibiotics brought to the market over the past 30 years have been variations on existing drugs. No new types of antibiotics have been discovered since 1984. While 37 new antibiotics are currently in development, Pew estimates that more than half of them won't be approved by the Food and Drug Administration.
What's hampering efforts to produce new antibiotics are the financial realities of drug development. Developing and bringing new drugs to market is expensive; that's why pharmaceutical companies are focusing their efforts on blockbuster drugs for chronic diseases, which patients may have to take for many years and promise large, steady returns.
New antibiotics, on the other hand, would be used sparingly to prevent development of resistance and would bring a much smaller return. So there's little financial incentive for drug companies to pursue antibiotic development.
"That's why there are only four large pharmaceutical companies making antibiotics today," Joe Larsen, PhD, acting deputy director of the Biomedical Advanced Research and Development Authority (BARDA), a division of HHS, said in a news release. He said there were 18 in 1990.
Larsen said the result is that the world now has a "huge innovation gap in antibacterial drug development."
Recognition of the need to provide drug makers with a financial incentive to develop new antibiotics has been growing. For example, the Review on Antimicrobial Resistance, a panel commissioned by the British government, has called for a $40 billion global fund to spur research into new antibiotics and alternative therapies.
The idea behind this "AMR Innovation Fund" is that it would create an incentive for pharmaceutical companies to develop new antibiotics by providing up-front payments, thereby eliminating the need for companies to sell antibiotics in large quantities. The group estimates that increasing resistance to antimicrobial drugs, if not addressed, could lead to 10 million deaths a year by 2050.
Investment for early-stage development
The partnership will focus on selecting, investing in, and providing technical assistance to biotech start-ups and university labs working on early- and middle-stage development of antibiotics. The hope is that large drug companies will then be able to pick up the most promising candidates for late-stage development and guide them through human trials and regulatory approval.
It's a model that could stimulate much-needed development of novel, structurally different antibiotics, said John Rotschafer, PharmD, professor at the University of Minnesota's College of Pharmacy. "Any time you can add capital to a project, it's going to broaden the effort," he told CIDRAP News. "And one of the problems right now is that there is limited effort to develop new products."
The Infectious Diseases Society of America (IDSA) has been calling for just this type of public-private partnership, the organization said in a news release e-mailed to journalists, noting that infectious disease physicians are on the front lines of the battle against drug-resistant bacteria and that new antibiotics are desperately needed.
"IDSA is hopeful the new accelerator will foster the discovery, research, and development of truly novel antibiotics," the group said.
But Erik Gordon, JD, professor at the University of Michigan's Ross School of Business, expressed some skepticism about the effort.
"Antibiotic development needs the backing of non-profit organizations to make the economics work," he said. He added, however, "I'm not sure funneling that much money into an accelerator system based at a law school, where few antibiotics have ever been developed, with so many cooks, is the best use of the money or the best way to develop the new antibiotics we need."
BARDA will oversee the effort on the US side, along with the National Institute of Allergy and Infectious Diseases, while the Wellcome Trust and the AMR Centre will oversee antibiotic research and development efforts in Britain. As alluded to by Gordon, Boston University School of Law will be the headquarters.
CARB-X will start reviewing applications in September to determine the most promising products to support.
Jul 28 HHS news release
May 11 Pew Charitable Trusts report on antibiotic development
May 19 CIDRAP News story "UK group calls for $40 billion to tackle antibiotic resistance"