BARDA signs contract for single-dose flu antiviral

The United States Biomedical Advanced Research and Development Authority announced a contract for Biota Scientific Management Pty., Ltd., of Melbourne, Australia, to develop a long-acting, single-dose influenza antiviral drug in the U.S.

The drug, known as CS-8958, has been marketed in Japan under the name Inavir. It is a similar drug to the currenlyt approved influenza antiviral drugs Relenza and Tamiflu. CS-8958 only requires a single dose for full treatment, unlike Relenza and Tamiflu, which require five days of twice daily dosing.

The contract is worth $231 million over five years. CS-8958 may be effective for influenza viruses that are known to be resistant to Tamiflu.

“This award represents another critical step forward in ensuring that safe and effective antiviral drugs are available for the treatment of influenza,” Dr. Robin Robinson, BARDA's director, said. “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.”

The drug is a long-acting neuraminidase inhibitor, which acts by preventing the flu virus from spreading in the cells of the body. CS-8958 is delivered using a dry powder inhaler.

The contract will allow the company to establish U.S. manufacturing for the drug, optimize its manufacturing processes and conduct clinical trials for efficacy and safety in pediatric and adult populations. The trials are required to apply for the U.S. Food and Drug Administration approval of the drug.