Public Health Emergency - Leading a Nation Prepared
HHS, Regeneron partner on portfolio of treatments for pandemic influenza, emerging infectious diseases
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Regeneron Pharmaceuticals, Inc. of Tarrytown, New York, will forge a public-private partnership to drive development of an entire portfolio of products to treat influenza and other emerging infectious diseases.
The Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, and Regeneron will share the oversight and cost of developing new therapeutics to treat influenza and emerging pathogens that pose a significant risk to public health. BARDA initially will contribute $18.7 million.
“Influenza and other emerging infectious diseases present serious threats to our nation’s health security,” explained BARDA Director Rick Bright, Ph.D. “This partnership will support much-needed treatment options for those who are severely ill with influenza and the rapid drug development that is critical to save lives when a new disease emerges.”
The products developed through this partnership will leverage Regeneron’s monoclonal antibody discovery platform which the company used in developing treatments for MERS coronavirus and Ebola. The technology directly links antibody discovery to clinical manufacturing. This technology shortened the development timeline during those emergency responses to months instead of years.
Monoclonal antibodies are produced by a single clone of cells or a cell line with identical antibody molecules. These antibodies bind to certain proteins of a virus to disable it and also stimulate the patient’s immune system to attack the virus-infected cells.
Initially the partners will use the technology platform to develop a next-generation monoclonal antibody treatment for patients hospitalized with severe influenza. In addition, the flexibility of the partnership allows development of therapeutics to treat infections caused by pathogens that emerge in the future. The partners also could use the technology in rapidly developing products during a public health emergency.
Rather than a standard agreement, ASPR and Regeneron will collaborate using an Other Transaction Agreement (OTA) under authority granted to HHS under the Pandemic and All Hazards Preparedness Act of 2006. The OTA provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development of medical products needed in a public health emergency.
This portfolio partnership is the sixth that BARDA has formed using Other Transaction Authority. One of the previous partnerships focused on influenza therapeutics and vaccines, and the other four focused on developing new products to address chemical, biological, radiological and nuclear (CBRN) threats and antimicrobial drug resistance.
As a division of ASPR, BARDA takes a comprehensive integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for CBRN and naturally occurring public health medical emergencies.
BARDA partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to mitigate the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to support approval or licensure by the U.S. Food and Drug Administration.
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 in preparing 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.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.
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