February 18, 2020
HHS, Janssen Collaborate To Develop Coronavirus Therapeutics
As part of the rapid global response to the 2019 novel coronavirus (SARS-CoV-2), the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) will use an existing partnership with Janssen Research & Development, part of Johnson & Johnson, to help develop treatments for coronavirus infections.
The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will collaborate with Janssen to identify medicines that might be used safely and effectively to reduce the severity of illness and treat coronavirus infections. The company also will identify compounds that have antiviral activity against SARS-CoV-2 as an initial step in developing new treatments. Currently, there are no vaccines or therapeutics approved by the U.S. Food and Drug Administration (FDA) to treat or prevent novel coronavirus infections.
"This is the third coronavirus to emerge and cause severe respiratory disease in humans within 18 years, and there are still no proven therapies to treat this disease," said BARDA Director Rick A. Bright, Ph.D. "In partnering with Janssen, BARDA is breaking this barrier to protect against this, as well as the next, coronavirus outbreak. This partnership may accelerate discovery and development of a new potentially lifesaving medicines for people with coronavirus infections."
This library to be screened consists of approved therapeutics as well as investigational therapeutics that have completed some clinical trials so that basic safety and pharmacology data are available for these compounds. If screening is promising, candidates then could be considered for further development, including assessment in additional clinical studies.
To screen compounds, Janssen will work with the Rega Institute for Medical Research (KU Leuven) in Belgium. The arrangement couples the Institute's infrastructure, high throughput screening experience, and capabilities for studying special pathogens with Janssen's drug development resources and antiviral expertise.
BARDA is also working with Janssen to develop a novel coronavirus vaccine. BARDA has collaborated with the company to develop treatments and vaccines to protect against multiple infectious diseases, such as Ebola and novel influenza viruses with pandemic potential.
In addition to expanded collaboration with Janssen, BARDA is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments, and diagnostics from across the public and private sectors to identify promising candidates that could be developed to detect, protect against or treat people with coronavirus infections.
These products include those in development to treat and prevent Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), which are caused by coronaviruses related to SARS-CoV-2.
To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, this task force launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their relevant diagnostics, therapeutics, vaccines, and other products or technologies. The task force is particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and/or utilize an FDA-cleared diagnostic platform.
To further support the novel coronavirus response, BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize FDA-cleared platforms, with a viable plan to meet requirements for the FDA to consider issuing an Emergency Use Authorization within 12 weeks of an award.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in innovation, the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation's health security. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov, and for more on DRIVe, visit drive.hhs.gov.