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New global approach and greater financial incentives needed to drive antibiotic innovation, concludes Drive-AB final study on combating the global drug resistance threat

New global approach and greater financial incentives needed to drive antibiotic innovation, concludes Drive-AB final study on combating the global drug resistance threat

$1-billion market-entry reward for each new antibiotic approved, doubling research investment for groups like CARB-X, and new concerted approach needed to drive antibiotic innovation and ensure access and sustainable use

(BOSTON, USA) – January 24, 2018 – A high-profile international consortium has recommended bold new measures to combat the rising threat of drug-resistant bacteria. In its final study made public today in Davos, Switzerland, the consortium concluded that increased financial incentives and concerted global coordination are essential to winning the fight against the steadfast global rise of drug-resistant bacteria.

The in-depth study, titled Revitalizing the Antibiotic Pipeline: Stimulating Innovation while Driving Sustainable Use and Global Access, was produced by DRIVE-AB (Driving Re-investment in research and development for antibiotics and advocating their responsible use), a group of 16 public-private partners supported by the European Innovative Medicines Initiative (IMI) and 7 major pharmaceutical companies. Its main conclusions, designed as a package of complementary measures:

  • Big reward: Create a $1-billion market-entry reward to companies for each new antibiotic approved to attract more private investment antibacterial research. This prize would be in addition to any sales revenues.
  • Increase R&D funding: Increase funding for governmental or non-profit pipeline coordinators, like CARB-Xand GARDP, that identify and support the promising research into antibiotics, vaccines and diagnostics to treat the most serious drug-resistant bacteria. Countries are investing an estimated $550 million each year in various R&D development initiatives. While significant, this level is far too low and should be increased to at least $800 million each year for the coordinators. Increased funding for basic research is also needed.
  • Long-term commitment from governmental: The study suggests that the G-20, through its member countries, would be ideally positioned to take the lead globally on public funding of R&D and coordinating efforts to ensure a predictable supply of antibiotics over the next 30 years.

The measures would cost an estimated $36 billion and produce some 20 new antibiotics over the next 30 years, which would go a long way to saving lives and battling the rise of superbugs. Bacterial infections are responsible for the deaths of 700,000 people worldwide, according to the World Health Organization. In the US alone, the Centers for Disease Control and Prevention (CDC) estimates that drug-resistant infections kill 23,000 people each year, many of them in hospital and health-care settings.

“There is no quick fix to solving the global drug-resistance crisis, and it will take increased funding into R&D and concerted global action to win this battle,” said Kevin Outterson, Executive Director of CARB-X, and an author of the DRIVE-AB final report. “The world urgently needs new antibiotics, vaccines, diagnostics and other products to treat drug-resistant bacterial infections and combat the rising threat of drug resistance. We are making progress but much more is needed, and the DRIVE-AB study provides a roadmap to how we can win this fight.”

The DRIVE-AB study is among the most comprehensive and in-depth studies ever conducted into the rising threat of drug resistance and how best to drive innovation at a faster pace than the rise of drug resistance. In developing its recommendations, DRIVE-AB assessed 30 incentives gathered from different industries to select the best. The study took more than three years to complete.

DRIVE-AB, which has concluded it mandate, was a public-private consortium from 11 countries (academic institutions, research organisations and pharmaceutical/biotechnology industries). DRIVE-AB was one of several projects within the Innovative Medicines Initiative (IMI)’s NewDrugs4BadBugs (ND4BB) program with a budget of €9.4 million. The purpose of the project was to transform the way policy makers stimulate antibiotic innovation, while ensuring that these new antibiotics are used sustainably and are available equitably to meet public health needs. To achieve this vision, DRIVE-AB used a research-based multidisciplinary approach with significant stakeholder input and interactions. DRIVE-AB partners included the public/academic partners British Society for Antimicrobial Chemotherapy, Chatham House, Center for Anti-Infective Agents, Heidelberg University, London School of Economics and Political Science, Norwegian Institute of Public Health, Radboud University Medical Center, Tel Aviv Sourasky Medical Center, University of Antwerp, Université de Genève, Université de Lorraine, University of Rijeka Medical Faculty, University of Strathclyde, University of Tübingen, Uppsala University, Wageningen University and EFPIA members Astellas Pharma Europe LTD, AstraZeneca AB, GlaxoSmithKline Research & Development, F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme, Pfizer Limited and Sanofi-Aventis Research & Development.

For information about DRIVE-AB and the IMI
http://www.imi.europa.eu/projects-results/project-factsheets/drive-ab
http://drive-ab.eu/drive-ab-outputs/drive-ab-reports/

The content of the Drive-AB report and CARB-X press release are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or the Wellcome Trust.

CARB-X Media Contact:

CARB-X:
Jennifer Robinson, CARB-X Communications
carbxpr@bu.edu

About CARB-X
CARB-X is one of the world’s largest public-private partnership devoted to early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI). http://www.carb-x.org/.

About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK)

About HHS, ASPR and NIH
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

ASPR leads HHS’s efforts to prepare the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. For more information about NIH and its programs, visit www.nih.gov. News releases, fact sheets and other NIAID-related materials are available on the NIAID website: https://www.niaid.nih.gov.

About Boston University
A leading research university with over 33,000 undergraduate and graduate students from more than 130 countries, nearly 10,000 faculty and staff, 17 schools and colleges, and 250 fields of study. Boston University is consistently ranked among the world’s best research universities and is a member of the American Association of Universities. For further information, see www.bu.edu or contact Ann Comer-Woods anncomer@bu.edu

About the Broad Institute of MIT and Harvard
Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community. Founded by MIT, Harvard, Harvard-affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, go to http://www.broadinstitute.org. In support of CARB-X, the Broad Institute created the Collaborative Hub for Early Antibiotic Discovery (CHEAD), which serves an interdisciplinary center that partners with academic investigators engaged in antibiotic development and/or resistance research to accelerate their early-stage, small molecule therapeutics toward Investigational New Drug (IND) application.

About MassBio
MassBio is a not-for-profit organization founded in 1985 that represents and provides services and support for the world’s leading life sciences supercluster.

MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives.

Representing 1000+ biotechnology companies, academic institutions, disease foundations and other organizations involved in life sciences and healthcare, MassBio leverages its unparalleled network of innovative companies and industry thought leaders to advance policy and promote education, while providing member programs, events, industry information, and services.

About the California Life Sciences Institute (CLSI)
The mission of the California Life Sciences Institute (CLSI) is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. Located in the birthplace of biotechnology, CLSI strives to ensure that the economic and intellectual power of the region’s life sciences industry and its employees remains strong. By maintaining its focus on entrepreneurship, education and career development programs, CLSI supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. As a non-profit 501(c)(3), CLSI’s objectives are met through collaborations, partnerships, and the generosity of individuals, sponsors and foundations. CLSI is a member of the CARB-X consortium, serving as an accelerator. Learn more at http://califesciencesinstitute.org.

About RTI International
RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.