In May, the Biomedical Advanced Research and Development Authority (BARDA), the US government agency charged with developing countermeasures to bioterrorist threats, struck a novel type of collaboration deal with GlaxoSmithKline (GSK) to develop several antibacterial agents. The agreement gives the London-based pharma $40 million over the first 18 months and up to $200 million over five years, under a new type of flexible structure. Instead of focusing on a single medical countermeasure, BARDA can shift funds around GSK's antibacterial portfolio. The “portfolio approach” is a more efficient way to partner with the company, says BARDA director Robin Robinson, of Washington, DC. With the new partnership, “if one or more drugs do not meet our requirements we will replace them with others in the GSK pipeline,” says Robinson. The partnership, funded by BARDA's Broad Spectrum Antimicrobial Program, allows the government agency to decide which drug candidates to include in the portfolio. GSK will conduct the preclinical and clinical studies to develop antibacterials for bioterrorism indications such as anthrax, plague and tularemia as well as address antibiotic resistance—part of BARDA's strategic plan since 2011. One new class of antibiotic investigated under this program is GSK'944 to treat bacterial infections acquired in hospital and community settings. “Because of economic and regulatory barriers, very few pharmaceutical companies pursue antibiotic R&D,” says Amanda Jezek at the Infectious Disease Society of America. “This type of public-private collaboration is critical to help leverage government and industry funding for antibiotic R&D.” Also in May, BARDA signed a $75.7-million deal with Cempra of Chapel Hill, North Carolina, to develop solithromycin (licensed from Optimer Pharmaceuticals, of Jersey City, New Jersey), a next-generation fluoroketolide antibiotic in phase 3 trials to treat community-acquired bacterial pneumonia, and potentially anthrax and tularemia infections, in children. BARDA currently has 140 drug candidates in its pipeline, 80 of which are directed against chemical, biological, radiological and nuclear defense. The majority were developed through partnerships with companies, says Robinson.
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Sinha, G. BARDA to pick and choose next-generation antibiotics. Nat Biotechnol 31, 665 (2013). https://doi.org/10.1038/nbt0813-665
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