The European Union/industry Innovative Medicines Initiative (IMI) has launched its ninth call for proposals, with a total budget of 135 million euros and a focus on age-related conditions, tapping into social media to monitor drug safety and advances in antibiotics.
IMI is the world's largest public/private partnership in health, and 63 million euros of the new budget is contributed from the European Union (EU) Seventh Framework Programme, while 72 million euros comes as in-kind contributions from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Included in this latest call is a topic that will use frailty and the associated loss of muscle mass and strength as a paradigm for the development of better treatments for other age-related conditions. Although the number of Europeans aged 65 and over is set to rise from 85 million in 2008 to 151 million in 2060, today's healthcare and associated regulatory systems are not geared towards this growing segment of the population, says IMI.
This topic will work to develop innovative therapeutic interventions against physical frailty and sarcopenia as a prototype geriatric indication, to help speed up the development of new, more effective treatments. It will include a large-scale clinical study to compare the effectiveness of a state-of-the-art treatment programme centred around physical activity with a healthy-ageing counselling program without regular physical activity.
The budget for this topic is 49.31 million euros, 24 million euros of which comes from the EU and 25.31 million euros from EFPIA in-kind contributions.
Another proposed project is WEBAE (Web Adverse Events), which seeks to leverage emerging technology for pharmacovigilance. The topic will develop tools to tap into the wealth of information that is openly available through social media, apps and online platforms to both detect adverse drug reactions (ADRs) and provide patient swith the most up-to-date drug safety information.
The budget for this topic is 4.56 million euros, with 2.27 million euros coming from the EU and 2.29 million euros from EFPIA in-kind contributions.
The ninth call also expands IMI's programme on antimicrobial resistance, entitled new Drugs For Bad Bugs (ND4BB). The focus of one of the topics is the urgent need to develop a new business model for antibiotic development that will reinvigorate investment in this vital area. The project resulting from this topic will have to tackle a contradiction at the heart of antibiotic development - on the one hand, pharmaceutical companies make money by selling large volumes of the drugs they develop. On the other hand, the use of new antibiotics should be restricted, in order to minimise the risk of bacteria developing resistance to them. The result is that sales are low and the costs of development frequently exceed the potential return on investment.
This new project will develop concrete recommendations for new commercial models that provide industry with an incentive to invest in this area while ensuring that new antibiotics are used wisely, says IMI.
The budget for this topic is 9.4 million euros, 6.3 million euros of which will come from the EU and 3.1 million euros from EFPIA in-kind contributions.
Finally, the new call for proposals includes a topic on the clinical development of antibiotics to treat resistant Gram-negative pathogens such as E coli. Drug-resistant Gram-negative bacteria are responsible for two-thirds of the 25,000 deaths resulting from antimicrobial resistance reported in Europe each year. This new topic will focus on gathering data on the best-available therapy for hospitalised patients with serious infections caused by multi-drug-resistant organisms. These data will help to improve the design of clinical studies, thereby increasing the efficiency of antibiotic R&D, and this will be tested with a new combination medicine targeting serious Gram-negative infections.
The budget for this topic is 72.1 million euros, with 30.55 million euros coming from the EU and 41.55 million euros from EFPIA in-kind contributions.
The deadline for submitting expressions of interest on all these topics is October 9, 2013.