IMI plans "unprecedented" programme for novel antibiotics as drug resistance continues to rise
This article was originally published in Scrip
The EU's Innovative Medicines Initiative (IMI) is to launch a new collaborative programme in the next few months aimed at boosting the discovery and development of novel antimicrobial medicines, as pressure grow for more action to tackle the problem of bacterial resistance.
At the same time, the European Commission is working towards an overarching agreement with the pharmaceutical industry on longer-term public-private collaboration, involving funding under current and future EU research programmes, to support research, development and approval of new antibiotics.
The moves are the result of ongoing high-level discussions between the European industry federation EFPIA and the commission, which together head up the IMI. EFPIA director general Richard Bergström described the IMI programme as "unprecedented" and said it represented "very new ground" for the industry.
The IMI programme and the longer-term agreement with the industry are among a number of steps that the commission says must be taken if antimicrobial resistance is to be tackled effectively. They are part of an "action plan" that was launched by the commission on 17 November to mark "European antibiotic awareness day".
The action plan covers seven areas where measures are urgently needed, and lays out 12 concrete actions to be taken over the next five years. They include heightening awareness of resistance and its causes, promoting more judicious use of antibiotics in both humans and livestock, strengthening surveillance systems on antimicrobial consumption, and developing new, effective antimicrobials.
Health commissioner John Dalli said it was vital to take "swift and determined action if we do not want to lose antimicrobial medicines as essential treatment against bacterial infections in both humans and animals". Finding the next generation of antibiotics, he said, was "crucial if we are to stay ahead of the curve in the face of bacteria and other pathogens which are resistant to drugs".
Work has already begun on drafting work packages for the IMI programme, and these should be finalised over the next few months. After that the IMI will issue calls for R&D projects, said Mr Bergström, who told Scrip in September that high-level talks on public-private collaborations were under way (scripintelligence.com, 22 September).
The expectation is that academics, SMEs and larger companies will come on board in a collaborative platform that will involve the sharing of expertise and experience, including past successes and failures in drug development. This would enhance efficiency across the R&D process while retaining a "competitive dynamic" to ensure that truly innovative approaches are developed, Mr Bergström said.
The emphasis is on open collaboration as a way of ensuring that work on the development of novel antibiotics is as efficient as possible. Three workstreams are envisaged: one on the sharing of information; one on new drug discovery tools, including novel mechanisms and targets; and one on the conduct of joint clinical trials.
The total value of the IMI programme, excluding the joint clinical trial element, Mr Bergström told Scrip, would be around €150 million; including clinical trials it could be nearer €350 million.
Industry support
The concept already has strong support from industry CEOs at EFPIA board level, with companies such as GlaxoSmithKline and AstraZeneca showing particular interest, Mr Bergström said in an interview with Scrip.
Andrew Witty, CEO of GSK and president of EFPIA, said the current commercial model did not stimulate the innovation that was needed in this area. A "fundamentally different approach and public-private collaboration, with the sharing of information and funding, provides us with a significant opportunity to reduce the hurdles in our way".
"But there is also realism in this," according to Mr Bergström, who said that constructing the collaboration would take a great deal of work.
EU research funding
Moreover, longer-term support, including both private and public financing, will be needed if investment in antibiotic R&D is to be strengthened and sustained. This is being pursued, inter alia, through the commission's research funding programmes.
The commission said in its action plan that it would seek to establish an "overarching framework agreement" with the industry, defining objectives, commitments, priorities, principles and "modes of action" for public-private collaboration in the longer term.
"Adequate financial resources" would need to be mobilised, through the IMI, the EU's 7th framework programme and, eventually, "Horizon 2020", the proposed new research and innovation programme for 2014-2020 that is currently being put together, the commission added.
Mr Bergström cautioned that it would also be important to get public support for such co-funding, particularly at a time of economic and financial retrenchment. Industry would also need to show the public sector that it was sharing not just the risks of new drug development but also the benefits – these could take the form of milestone payments to public research bodies, for example, he suggested.
Other aspects of bringing new antibiotics to patients will be addressed as part of the action plan, the commission said, including using the flexibilities in the EU pharmaceutical legislation to accelerate the approval of new medicines and working with stakeholders and member state authorities on establishing adequate market and pricing conditions.
Resistance still on the rise
The action plan came during a week when the European Centre for Disease Prevention and Control announced that that the percentage of carbapenem-resistant Klebsiella pneumoniae was increasing in the EU, with almost 50% of the bacteria in bloodstream infections now resistant in some countries. Carbapenems are the major last-line antibiotics for infections with multidrug-resistant Gram-negative bacteria, the ECDC noted.
The organisation recently published a risk assessment to evaluate the risk to European citizens of the spread of carbapenemase-producing Enterobacteriaceae in healthcare facilities in Europe. It found that the transfer of patients across borders posed "a clear risk" for the transmission of such bacteria.
And it has just issued another risk assessment that found that the spread of New Delhi metallo-beta-lactamase (NDM) and other highly resistance bacteria represent a particularly risk for the EU because the member states do not have systematic surveillance systems and policies to detect carriage or infection deriving from these bacteria.
Misuse continues too
As the commission and industry both point out, R&D efforts are only a part of the fight against the rise in bacterial resistance, which needs to be conducted on a global scale with the participation of all countries, particularly in terms of public awareness, rational use of antimicrobials, and infection prevention measures.
But despite the best efforts of the health authorities to inform health professionals and the public of the need to use antibiotics prudently – particularly in view of the fact that they have no effect on viral conditions – it seems little progress has been made.
A Eurobarometer survey for the commission last year found that 55% of Europeans wrongly believe that antibiotics kill viruses, and 47% that they are effective against colds and flu.
More recently, a survey by the UK Health Protection Agency published on 18 November revealed that people still ask for antibiotics for conditions such as coughs and colds, and that doctors still readily do so, even when their use is not indicated. It also found that while 70% of 1,700 people interviewed recognised that antibiotic resistance was a problem, a quarter of them believed that antibiotics work on most colds and coughs, and half of those who visited a doctor with a cough, cold, flu or sore throat expected to be prescribed an antibiotic.
The same day, the