Public Health Emergency - Leading a Nation Prepared
March 31, 2011: A contract has been awarded to develop a long-acting single-dose antiviral drug for use in the United States, the U.S. Biomedical Advanced Research and Development Authority (BARDA) announced today.
The drug, CS-8958, is currently marketed in Japan under the name Inavir and is in the same class of drugs as the currently approved influenza antiviral drugs Tamiflu and Relenza. CS-8958 requires only a single dose for full treatment, as opposed to the five days of twice daily dosing required for Tamiflu and Relenza. CS-8958 also may be effective against influenza viruses known to be resistant to Tamiflu.
The advanced development contract for was issued to Biota Scientific Management Pty, Ltd., of Melbourne, Australia, for $231 million over five years.
“This award represents another critical step forward in ensuring that safe and effective antiviral drugs are available for the treatment of influenza,” said BARDA Director Dr. Robin Robinson. “The ability to treat influenza by delivering a single dose of medicine would provide real advantages to doctors and patients during an emergency and would be an important addition to our pandemic influenza arsenal.”
CS-8958 is a long-acting neuraminidase inhibitor, which prevents the flu virus from spreading in the body’s cells. The drug is delivered using a dry powder inhaler.
Under the contract, the company will establish U.S. manufacturing of the drug, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for U.S. Food and Drug Administration approval of the drug.
The contract is part of BARDA’s implementation of the national pandemic influenza preparedness strategy, which includes accelerating the advanced development of new antiviral drugs.
BARDA, an agency within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.
For more information about BARDA and the national influenza preparedness strategy, visit www.phe.gov. Information about the flu is available at www.flu.gov.
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
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