The growing threat from antibiotic resistance met the era of the public–private partnership on 24 May, as the European Union’s Innovative Medicines Initiative (IMI) launched a new seven-year effort to bring academic and industry researchers together to work on the problem.
Dubbed NewDrugs4BadBugs, the call for proposals is supported by a budget of €223.7 million (US$280 million), with roughly half of the money to come from the IMI and the remainder from companies GlaxoSmithKline, AstraZeneca, Janssen, Sanofi and Basilea Pharmaceutica. Their contributions will include scientific expertise, clinical-trial managers and the drugs themselves. As the programme progresses, it could eventually disperse some €600 million to researchers working to develop new antibiotics.
The programme is part of the Action Plan Against the Rising Threats from Antimicrobial Resistance, a strategy announced by the European Commission late last year to fight the rise of drug-resistant ‘superbugs’, from harmful strains of Escherichia coli to methicillin-resistant Staphylococcus aureus, or MSRA (pictured).
Initially, the programme will focus on improving clinical-trial design and learning from past successes and failures. Proposals from prospective applicants are due by 9 July 2012, with more solicitations to follow during 2012–13. The ultimate aim: to boost a pipeline of new antibiotics that the World Health Organization has called “virtually dry”.
Sponsors say that the programme will encourage participants to share information — including what hasn’t worked in past — to avoid duplication and improve clinical trials, making them more rational and targeted.
The need for better antibiotics is urgent, as today’s call for proposals notes: the cost of antimicrobial resistance is estimated at around €1.5 billion annually in Europe, and only two new classes of antimicrobials have been brought to market in 30 years. Faced with poor financial incentives and regulatory and scientific hurdles, drug developers have largely fled the field.
“Today marks a chance to reverse the threat,” said Patrick Vallance, president of pharmaceuticals research and development (R&D) at GlaxoSmithKline.
AstraZeneca’s president for R&D, Martin Mackay, said: “It is time to tackle this issue in a different way.” Sharing information and expertise among public and private partners is “critical” to beating the superbugs, he added.
As part of NewDrugs4BadBugs, GlaxoSmithKline will contribute an experimental antibiotic, GSK1322322, which targets multidrug-resistant respiratory and skin infections, including MRSA. It’s now in phase II development. AstraZeneca intends in several months to contribute two experimental medicines that are at an earlier stage of development, provided no problems arise with them in the meantime. They are MEDI4893, a novel monoclonal antibody that attacks a toxin released by S. aureus; and AZD9773, an investigational treatment for severe sepsis and septic shock, life-threatening conditions that can be triggered by uncontrolled bacterial infection.
The funding announcement is the latest in a series by the four-year-old IMI, a multibillion-dollar partnership between the European Commission and drug companies to attack bottlenecks in drug development by funding small and medium-sized companies, academic researchers and non-profits.
It is not clear how enthusiastically academic scientists will respond to today’s call. On the heels of earlier research funding rounds by IMI in other areas, academic groups and universities complained that they were obliged to give up valuable intellectual-property rights to participate in IMI-funded projects. Unless the rules were improved to protect their interests, they said, academic participation would decrease in future.
Photo credit: Janice Carr