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A pipeline push from a public-private partnership

A multimillion-euro partnership between industry and the European Union promotes research and communication on developing new antibiotics.

Every year in Europe, 25,000 people die from bacteria that are resistant to antibiotics. Yet, antibiotic drug development has not been a priority at pharmaceutical companies over the past few decades, says epidemiologist and physician Andreas Heddini, medical advisor at GlaxoSmithKline in Solna, Sweden. The early success of using antibiotics against infections, he says, “led us to believe this problem belonged to the past. Clearly, that is not the case.”

In a new collaboration called NewDrugs4BadBugs, GlaxoSmithKline, AstraZeneca, Sanofi, Janssen, Basilea Pharmaceutica, and the European Union are tackling the threat of resistant microbes. The program is part of the European Commission action plan against antibiotic resistance announced in November 2011. The budget for the first proposals was €115 million from in-kind contributions from the industry partners and €109 from the European Commission through the Innovative Medicines Initiative (IMI), a joint undertaking of the European Union and the European Federation of Pharmaceutical Industries and Associations. The first proposal topics were in innovative trial design and clinical drug development, as well as learning from success and failure and getting drugs into microbes.

New approaches

The overall goals of NewDrugs4BadBugs are to increase our understanding of antibiotic-resistance mechanisms to help identify new candidates and new approaches to designing antibiotics. The program also aims to move existing candidates through the pipeline, and minimize duplication of effort by encouraging knowledge sharing about what does and does not work in developing new antibiotics. The plan for knowledge sharing is a data repository that will initially be available to members of research consortia funded by NewDrugs4BadBugs, but will later be open to the wider scientific community.

“We want to create a network of investigators across Europe, including clinical investigators,” says Michel Goldman, Executive Director of the IMI and Professor of Immunology at the Faculty of Medicine of the Université Libre de Bruxelles. He says the network could help pharmaceutical companies identify partners for research and trials.

Clinical trials

The next call for proposals, expected in mid-to-late November 2012, will cover two topics. One is early drug discovery aiming to move candidate compounds from hits to leads that can be tested in Phase I trials. The other is later-phase trials on an AstraZeneca/Medimmune monoclonal antibody drug targeting a toxin from Staphylococcus aureus. Another antibiotic in development that could be advanced by NewDrugs4BadBugs is the GlaxoSmithKline compound GSK1322322, currently in Phase II testing. This compound targets an enzyme specific to bacteria, and could be useful against multidrug-resistant respiratory and skin infections including MRSA (methicillin-resistant S. aureus). MRSA is a common cause of infections acquired during hospital stays and can cause serious problems, including life-threatening systemic infections.

The first 2013 call for proposals under NewDrugs4BadBugs is expected to focus on Gram-negative bacterial infections. Currently, few treatment options are available for this category of microbes, which often require different antibiotics from those used to treat, for example, S. aureus. Executive Director Goldman encourages researchers to consider projects saying, “We want to attract applicants, including applicants from Nordic countries.”

Other future funded topics might include discovery of human drug targets, and regulation and responsible use of antibiotics. The latter is of particular importance as we develop new antibiotics, says Dr. Heddini, and it affects all aspects of the pharma value chain.
“If we overuse these drugs, we lose them,” he says. “Assuming we get new antibiotics to market, how will we distribute them in a responsible way? Some people are beginning to think about this, but it needs more focus now.”