The European Commission/pharmaceutical industry's Innovative Medicines Initiative (IMI) is launching a 223.7 million euro programme today aimed at tackling antibiotic resistance and speeding up the delivery of new antibiotics to patients.
Leading academics and five major pharmaceutical companies will join forces through the new programme, which is part of the Commission's Action Plan Against the Rising Threats from Antimicrobial Resistance, introduced last November. Today sees the launch of the first set of projects to be funded in this area, announced in IMI's sixth Call for Proposals, with a joint budget of up to 223.7 million euros for the projects. This consists of 109 million euros of IMI funding and 114.7 million euros provided through in-kind contributions by participating member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
With a number of additional projects currently in development, this major programme on antimicrobials is expected to utilise up to 600 million euros-worth of funding over the next seven years. Underpinned by an unprecedented level of data-sharing, it offers an antidote to the fragmentation and lack of incentives which are currently holding back antibiotics research, says IMI. The initial projects will focus on building and training networks of researchers, facilitating and increasing the exchange of research data and improving the efficiency of clinical trials on new antibiotics through better laboratory tests and better trial design.
The novel trial design will be applied in clinical trials testing experimental antibiotics to fight particularly resistant bacteria. For instance, trials will target methicillin-resistant Staphylococcus aureus (MRSA), which causes difficult-to-treat infections that are of particular concern in hospitalised patients. In addition, new methods will be explored to improve antibiotic uptake by a specific group of (Gram-negative)-resistance bacterial pathogens. Antibiotic uptake is the key challenge in the development of drugs against these life-threatening infections, says IMI.
Antibiotic-resistant bacteria cause 25,000 deaths in the European Union (EU) every year, but despite the recognised need for new antibiotics, only two new classes of the drugs have been brought to market in the last 30 years. As well as significant scientific challenges and complex regulatory requirements, antibacterial drug development is no longer a financially-viable option for a pharmaceutical company, as the cost of development is often greater than the potential return on investment, notes IMI.
As a result, too few companies remain dedicated to addressing this essential societal need, but if this situation continues with no intervention, there is a real risk that prescribers will have few, if any, therapeutic options to treat bacterial infections.
"To avoid a real public health challenge, it is essential that action be taken now," says IMI.
"Our researchers and the scientific community have realised that we can only deal with this urgent threat by working together and pooling our knowledge," said Richard Bergstrom, director-general of the EFPIA. "IMI is perfected suited for such open innovation. And by co-funding clinical trials, policymakers in Europe have created a strong incentive for companies and investors to come back to this field of research," he added.
IMI executive director Michel Goldman said the initiative presents "a historic opportunity for Europe to overcome a public health problem which threatens millions of lives worldwide. For researchers in universities, hospitals and small and medium-sized enterprises [SMEs], it is also a unique opportunity to speed up their research in the area of antimicrobial resistance, as the collaboration will give them access to the knowledge and expertise of the pharmaceutical industry," he said.
- IMI is Europe's large public/private initiative aimed at speeding up the development of better and safer medicines for patients. It is a joint undertaking between the EU and EFPIA.