The objective of the proposed research programme is to improve the
underlying scientific understanding of antibiotic resistance, design and implement
efficient clinical trials and take novel drug candidates through clinical
development. The programme is part of the European Commission's Action Plan
Against the Rising Threats from Antimicrobial Resistance, launched in November
last year.
Set against a backdrop of emerging resistant bacteria and with the pipeline
of future antibiotics described by the World Health Organization (WHO) as
"virtually dry", this innovative research programme,
NewDrugs4BadBugs, intends to boost the currently faltering discovery and
development of new antibiotics.
Supported by the Innovative Medicines Initiative (IMI), Europe's largest
public-private initiative, the research programme's first projects will be
funded by a joint budget of up to € 223.7 million - € 109 million provided by
IMI and € 114.7 million in kind contributions from the pharmaceutical and
biotechnology companies involved. GlaxoSmithKline, AstraZeneca, Janssen, Sanofi
and Basilea Pharmaceutica will work alongside public research organisations and
scientific experts to address several aspects of resistance and stimulate new
antibiotic research. Further projects within the programme, with additional
funding, are expected to launch later in the year.
Antibiotic resistance is increasingly becoming a worldwide health threat.
Many of the medical advances in recent years, such as chemotherapy for cancer
treatment and organ transplantation, depend on effective antibiotics. Despite this
need and the continued emergence of bacteria resistant to existing drugs,
research has diminished over the past 15 years and few companies remain active
in this area. This is due to the scientific difficulties in finding new agents
that successfully target bacteria, regulatory complexities and a lack of the
commercial incentives needed to encourage investment in this area and to fund
future R&D.
Patrick Vallance, President, Pharmaceuticals R&D at GlaxoSmithKline,
said: "The rise of infections such as MRSA is well known, but today marks
a chance to reverse the threat. This announcement signals a new model of
collaboration and a willingness to change and adapt to seek different
solutions. GSK has a legacy in the development of new antibiotics going back 40
years and we remain active in this field of research. We can bring our
scientific innovation and expertise to this novel collaboration which, in
combination with the different skills and resources provided by other partners,
provides a real opportunity to address the needs of patients today and prepare
for the potential threats of tomorrow."
Martin Mackay, President, R&D, at AstraZeneca, said: "The steady
rise of drug-resistant bacteria is an imminent and urgent threat to public
health, and without a reliable arsenal of effective antibiotics, modern medical
care is not possible. Bacteria develop resistance as fast, or faster, than we
can develop treatments and a combination of scientific, regulatory, and
financial challenges have impeded new antibiotic development.
"It is time to tackle this issue in a different way, sharing
information and expertise among public and private partners - collaboration of
this type is critical if we are to speed up the discovery of these medicines to
improve patient health."
The proposed research programme will initially focus on three key areas:
Progressing development of pipeline antibiotics
This funding will support new research that will progress potential antibiotics already under investigation through clinical trials and improve the design of future clinical trials.
GlaxoSmithKline's investigational antibiotic, GSK1322322, targeting
multi-drug resistant respiratory and skin infections including MRSA
(methicillin resistant Staphylococcus aureus) and currently in Phase II
development, will be included in the research programme. Pending the results of
ongoing work, these will be joined slightly later by AstraZeneca's MEDI4893, a
novel investigational monoclonal antibody in early stage development that
targets a toxin released by Staphylococcus aureus and AZD9773, an
investigational treatment for severe sepsis and septic shock, conditions
triggered by uncontrolled bacterial infection.
Information sharing
The collaboration will be underpinned by an unprecedented level of data and knowledge sharing. It is hoped that developing a platform to enable the sharing of knowledge and resources across multiple groups will improve the chances of success in developing the next generation of antibiotics.
A new information hub will allow the sharing of knowledge and data between
participants and across the wider antibiotic research community to enable the
field to learn from antibiotic development successes and failures and gain a
shared and improved understanding of the science behind antibiotic resistance.
This will minimise duplication of effort and reduce inefficiencies in future
R&D, supporting antibiotic research through the life of the programme and
beyond.
Participants will share information on the design of clinical trials and the
data generated, to support development of novel trials in the future that will
increase efficiency of antibiotic research. A clinical trial network will be
established to evaluate antibiotics currently in development, enabling experts
in clinical antibiotic research to work alongside the scientists developing
future medicines.
Continuing research and discovering new
antibiotics
Tackling infections caused by Gram negative bacteria is a very difficult challenge, owing to the particular defence mechanisms they employ. There are few treatment options available and currently limited ongoing development activities in this area. This research programme aims to find more approaches to the design of antibiotics that could be effective against Gram negative bacteria, increase understanding of their defence mechanisms and use this knowledge to support future drug discovery efforts.
Key to the success of NewDrugs4BadBugs will be the involvement of multiple
public partners from across Europe. Public institutions and research
organisations, clinical investigators and scientific experts are being
encouraged to learn more about the proposed research programme through a series
of events.
Three major areas have been identified as key barriers currently facing the
development of new antibiotics:
- Discovering new antibiotics is inherently difficult and finding novel agents that successfully target bacteria is scientifically challenging.
- Regulatory complexities specific to antibiotics compound this scientific challenge. For example, late stage clinical trials investigating antibiotics against resistant infections require an excess number of trial participants, as not all of those enrolled will be infected with the resistant strain of bacteria being targeted. This significantly impacts the practicalities and cost of running large trials.
- Low return on investment relative to other medicines limits the feasibility of antibiotic development for manufacturers. New antibiotics are used as little as possible, only when patients have failed to respond to existing treatments. This significantly limits the commercial return that is needed to encourage investment in this area and to fund future R&D.
About the Innovative Medicines Initiative (IMI)
The Innovative Medicines Initiative Joint Undertaking (IMI JU) is a unique pan-European public private partnership between the European Commission and EFPIA (European Federation of Pharmaceutical Industries and Associations) driving collaboration between all relevant stakeholders including large and small biopharmaceutical and healthcare companies, regulators, academia, and patients.
The aim of IMI is to propose a coordinated
approach to overcome identified research bottlenecks in the drug development
process, in order to accelerate the development of safe and more effective
medicines for patients, by fostering collaboration between all stakeholders
such as industry, public authorities (including regulators), organisations of
patients, academia and clinical centres, and enhancing Europe's
competitiveness.