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发布日期:2021年06月14日
Antimicrobials/Antibiotics

Vaccines and antibiotics have revolutionized infectious disease prevention and treatment, saving millions of lives worldwide.

Highlights
  • A supplemental New Drug Application (NDA) for ZERBAXA® (ceftolozane and tazobactam) to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia caused by certain susceptible Gram-negative bacteria was approved by the U.S. Food and Drug Administration (FDA) in June 2019
  • In July 2019, the FDA approved an NDA for the combination of relebactam and imipenem/cilastatin to treat adult patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible Gram-negative bacteria
Commitments

Our company is committed to working with health care providers, patients and governments to promote antimicrobial stewardship (AMS)—the appropriate use of antimicrobials—through education, implementation, research and advocacy initiatives across both human and animal health, with an emphasis on improving patient outcomes, population health and quality of care.

 

Rising levels of resistance to antimicrobials is a serious threat to public health, food safety and global security.

For more than 80 years, our company has played a significant role in the discovery and development of novel medicines and vaccines to treat and prevent infectious diseases in both humans and animals. This work includes the development of sulfamerazine, one of the world’s first antibiotics, in 1938 and one of the first methods for mass production of penicillin during World War II. Today, we are one of only a few large pharmaceutical companies that has sustained a focus in research and development (R&D) aimed at producing new vaccines and medicines to prevent and treat bacterial infections.

“The rise in infections that are resistant to current antibiotics has become one of the world’s most pressing public health problems. We are proud to reaffirm our long-standing commitment to develop new therapeutics to fight infectious diseases, and to continue to collaborate with others to support antimicrobial stewardship to help slow the rate of emerging resistance.”

Dr. Julie GerberdingExecutive Vice President and Chief Patient Officer

The global challenge of antimicrobial resistance (AMR)

Antimicrobials are medicines to treat and prevent infectious diseases caused by pathogens such as bacteria, viruses, fungi and parasites. Antibiotics, which are used to treat bacterial infections, are one of the most important types of antimicrobials. AMR occurs when a pathogen evolves to survive antimicrobial treatment. While such evolution is inevitable, AMR is developing more quickly due to the inappropriate use of antimicrobials. Bacteria resistant to multiple antibiotic medicines are becoming more common, jeopardizing our ability to treat what are historically considered minor infections. AMR increases the risks associated with infections that can be commonplace with surgery, chemotherapy and transplantation. Action is needed to slow down the development and spread of AMR so that the antimicrobials we have continue to work for as long as possible.

The health and economic consequences of antibiotic resistance are considerable and costly, making it a serious threat to population health that demands a concerted, global response. The estimates that there are at least 2.8 million antibiotic-resistant infections in the U.S. and at least 35,000 people die as a direct result of these infections each year.1 The cost of infections caused by resistant pathogens to the U.S. health care system is between $21 and $34 billion annually.2 In the European Union, drug-resistant bacteria are estimated to cause 25,000 deaths per year.3

Our Global AMR Action Plan describes our company’s long-standing commitment to the global fight against infectious disease and our efforts to help slow the rate of emergence of potentially deadly resistant organisms. The Global AMR Action Plan includes sections on how our company is:

  • Leading in infectious prevention through the development and production of vaccines to prevent infections and reduce the need for antibiotics
  • Driving innovation to discover and develop new treatments and antibiotic alternatives to address AMR
  • Advocating for policy solutions to support sustainable investment in the development of new tools to combat AMR
  • Advancing antimicrobial stewardship to improve patient outcomes and slow the development of AMR
  • Supporting global AMR surveillance through our Study for Monitoring Antimicrobial Resistance Trends (SMART), which provides data to the scientific community on AMR trends
  • Protecting and maintaining animal health by promoting vaccination and the responsible use of antibiotics
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Programs and initiatives

In 2017, we established an Exploratory Science Center in Cambridge, Massachusetts, which focuses on the earliest stages of discovery research to better understand the underlying biology of human disease. The center’s research explores the most promising areas of emerging disease biology and will be used to inform our company’s ongoing drug discovery.

Our company is engaging in a number of partnerships to advance work related to AMR. We work with on pre-clinical programs to develop, manufacture and commercialize compounds to potentially target Gram-positive and Gram-negative bacteria. We have ongoing collaborations with to develop proprietary synthetic phage candidates and our scientists have provided training through the (GARD-P) Memory Recovery and Exploratory Program.

Our company has partnered with Kyorin Pharmaceuticals, Ltd. to share antibiotic research data on the Pew Charitable Trust’s open-access Shared Platform for Antibiotic Research and Knowledge (SPARK). The contribution builds on data previously shared from a range of research programs–including those at academic institutions, non-profit organizations and other pharmaceutical companies–further expanding the free, interactive resource, which scientists around the world are using to pursue antibiotic research.

Supporting antimicrobial stewardship (AMS) to improve health outcomes

Our company is committed to working with health care providers, patients and governments to promote antimicrobial stewardship (AMS)—the appropriate use of antimicrobials—through education, implementation, research and advocacy initiatives across both human and animal health, with an emphasis on improving patient outcomes, population health and quality of care.

Education is foundational to AMS, and our company has helped support a variety of educational offerings through independent grants to international, national, regional and state organizations. This includes those with an infectious disease-based membership as well as other subspecialty and generalist organizations.

These grants have supported programs and web-based platforms to educate both providers and patients on diverse topics related to AMS, including clinical practice, infection control and prevention, policy, clinical research and animal health. Outside the United States, we provide preceptorships and workshops for health care providers to learn firsthand from other providers practicing AMS.

1U.S. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States 2019.
2Roberts, R.R., Hota, B., Ahmad, I., Scott, R.D., Foster, S.D., Abbasi, F., et al. (2009) “Hospital and societal costs of antimicrobial-resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship.” Clin Infect Dis 49:1175–1184.
3European Medicines Agency, European Centre for Disease Prevention and Control. "Joint technical report: the bacterial challenge—time to react."
4/The-Brand-Rankings.aspx?rankingID=370 (2019)
5Antibiotic pipeline: /en/research-and-analysis/data-visualizations/2014/antibiotics-currently-in-clinical-development (April 2020)
6/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf