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July 29 — The U.S. and the U.K. will work together to accelerate the discovery and development of new antibiotics to combat antibiotic resistance, agency representatives announced July 28.
CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) is “possibly the largest public-private partnership in the world dedicated to pre-clinical antibiotic development,” Joe Larsen, acting deputy director of the U.S. Department of Health and Human Services' Biomedical Advanced Research Authority (BARDA), said in a video. The collaboration will “dramatically restart” the creation of antimicrobial products, he said.
“The establishment of CARB-X is a watershed moment. Governments, academia, industry and non-government organizations have come together to operate under a common strategic framework to tackle a monumental public health threat of our time,” Richard Hatchett, BARDA acting director, said in a statement.
BARDA will provide $30 million for CARB-X during the first year, with up to $250 million contributed over five years. The U.K.'s AMR Centre will contribute $14 million up front and up to $100 million overall. The AMR Centre is a recently formed U.K. public-private initiative to develop antibiotics and diagnostics.
The ultimate goal, government representatives said, is to move promising antibiotic candidates through the critical early stages so they can attract enough private or public investment for advanced development and win approval by U.S. and British regulatory agencies.
Antibiotic resistance occurs when bacteria change in a way that reduces the effectiveness of antibiotics designed to cure or prevent infections. The overuse of antibiotics and the lack of development of new antibiotics leads to antibiotic-resistant superbugs.
According to a May report commissioned by the U.K., there are 50,000 deaths in the U.S. and Europe each year caused by multidrug-resistant infections, and 700,000 people die from them worldwide. The report adds that without effective intervention, by 2050 there will be 10 million people dying each year around the world from antibiotic-resistant infections.
Larsen said there are only four large pharmaceutical companies making antibiotics today, while in 1990 there were 18. Karen Bush, a professor of biology at Indiana University, told Bloomberg BNA in an e-mail in March 2015 that there were 36 large pharmaceutical companies conducting antibacterial research in 1980 and that by 2015 there were six: The Medicines Company, GlaxoSmithKline, Merck-SheringPlough-Cubist, Novartis, Roche and Sanofi-Aventis.
Gregory Daniels of Duke University pointed out at a session of the BIO International Convention in San Francisco in June that return on investment for antibiotics has always been challenging for U.S. drug companies. People stop taking an antibiotic once the infection is cured, and there have been recent efforts to get people to take fewer antibiotics. However, the U.S. business model is for volume-based reimbursement (10 LSLR 12, 6/10/16).
Larsen said, “With CARB-X, we're going to set up a diverse portfolio and expect to have 20 high quality products in that portfolio because 80 to 90 percent of new drugs fail in the early stages of development. The science just doesn't work out most of the time.”
But through the CARB-X project, Larsen said, “[w]e can accelerate the development of at least two products to reach clinical testing within five years, so that our chances of success are much higher.”
BARDA, the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and Boston University School of Law, where CARB-X will be headquartered, will participate in the collaboration for the U.S. The Wellcome Trust and the AMR Centre Alderley Park, Cheshire, will participate for the U.K.
Two U.S. nonprofit life science accelerators—the Massachusetts Biotechnology Council (MassBio) in Cambridge, and the California Life Sciences Institute (CLSI) of South San Francisco—will provide support for early stage antibiotic development projects. Kevin Outterson, professor of law at Boston University, will lead the CARB-X executive team and serve as the alliance's principal investigator.
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