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CARB-X funds Shionogi to develop an antibiotic to treat infections caused by the life-threatening CRE superbug

CARB-X funds Shionogi to develop an antibiotic to treat infections caused by the life-threatening CRE superbug

Shionogi is the first Japanese company to partner with CARB-X, expanding CARB-X’s global reach to 7 countries represented in the portfolio

03.22.2018 | CARB-X is funding Shionogi of Osaka, Japan, to support the development of a novel β-lactam antibiotic with potent activity against the dreaded superbug serine- and metallo-type carbapenemase-producers, including BL/BLI-resistant carbapenem-resistant Enterobacteriaceae (CRE). Under the agreement, Shionogi will receive an initial award of up to $4.7M, with the possibility of $2.9M more from CARB-X based on the achievement of certain project milestones.

“We are very excited to welcome the first Japanese company into the Powered by CARB-X portfolio, strengthening the global fight against drug-resistant bacteria. Shionogi’s commitment to antibacterial innovation and its reputation for research excellence bodes well for this new collaboration,” said Kevin Outterson, Executive Director of CARB-X. “The world urgently needs innovative approaches, like the Shionogi project, to protect us from drug-resistant bacteria. The projects in the CARB-X portfolio are in the early stages of research, and there is always a risk of failure. But if successful, they hold great potential to treat serious infections and to save lives.”

Takeshi Shiota, Senior Vice President Pharmaceutical Research Division, at Shionogi, said: “We are most honored to be chosen as the first Japanese company to partner with CARB-X. CARB-X support for antibacterial innovation is essential in accelerating the development of this drug to combat multi-drug-resistant bacteria. For over 50 years, Shionogi, as a research-driven pharmaceutical company, has developed and commercialized innovative oral and parenteral anti-infectives. We hope this collaboration opens new pages of our history.”

According to the World Health Organization (WHO), CRE bacteria represent a significant public health threat, are difficult to treat due to high levels of antibiotic resistance and are associated with high mortality. During the last decade, there has been a global increase in the incidence and prevalence of carbapenem-resistant gram-negative bacteria. Carbapenem-resistant gram-negative bacteria are highly transmissible and have the potential to cause outbreaks in health care settings.

Urgent global need for new antibiotics
New antibiotics, diagnostics and other products are needed urgently to treat bacteria that are increasingly becoming resistant to existing antibiotics. According to the WHO, an estimated 700,000 people die each year around the world from bacterial infections. In the US alone, an estimated 23,000 people die each year from drug-resistant bacterial infections, according to the CDC. Antibacterial innovation has declined over past decades while resistance has been on the rise.

CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, funds projects in 7 countries (France, India, Ireland, Japan, Switzerland, United Kingdom, United States) and is working to expand its pipeline with the best science from around the world.

The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development antibacterial projects with 8 new classes of antibiotics under investigation and 28 projects in all including therapeutics, vaccines and diagnostics to respond to the threat of drug-resistant bacteria.

Partnering to accelerate innovation
Since the beginning of 2017, CARB-X has announced awards projects totaling $73.9 million, plus an additional $89.0 million if project milestones are met, to accelerate the development of antibiotics and other products. These funds are in addition to investments by the companies. CARB-X is planning further funding announcements later this year.

CARB-X is a partnership between the UK charity Wellcome Trust and the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). CARB-X funding is part of an overall commitment of up to US$455m by the US government and Wellcome Trust over a five-year period from 2016-2021.

CARB-X is actively seeking global support from other governments, industry and civil society to expand its ability to fund the best science around the world to get the new life-saving treatments so urgently needed.

CARB-X’s identifies and funds promising early development research to treat the most serious bacteria. The goal is to support projects through the early phases so that they will attract additional private or public support for clinical development. The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the ‘Antibiotic Resistant Threats in the United States’ report published by the Centers for Disease Control and Prevention (CDC) in 2013 or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or Wellcome Trust.

Media Contacts:

CARB-X:
Jennifer Robinson
+1-514-914-8974
carbxpr@bu.edu

Shionogi:
Naoki Kouyama
+81-6-6209-7885
naoki.kouyama@shionogi.co.jp

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 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 Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” Shionogi’s research and development currently targets two therapeutic areas: infectious diseases, and pain/CNS disorders. For over 50 years, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic diseases and oncology/immunology. Contributing to the health and QOL of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp/en/.

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’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the federal public health and medical preparedness and response to disasters and other emergencies, on behalf of the Secretary of HHS. 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.

NIAID is one of the 27 Centers and Institutes of the National Institutes of Health (NIH) a component of the U.S. Department of Health and Human Services. NIH is the nation’s medical research agency, and 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.

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, 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. Learn more at MassBio

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.