FDA Approves BioCryst`s Intravenous Flu Drug

By Natalie Grover

The U.S. Food and Drug Administration has approved BioCryst Pharmaceuticals Inc's intravenous flu drug.

The single-dose drug is for adults who have acute uncomplicated influenza and may be unable to swallow pills, such as Gilead Sciences Inc's Tamiflu, or inhale GlaxoSmithKline Plc's Relenza.

"An IV (intravenous) drug would ensure that an appropriate dose is administered, which is a concern for oral and inhaled drugs in severely ill patients," Needham & Co analyst Serge Belanger said.

BioCryst's peramivir injection, to be sold as Rapivab, is the first antiviral influenza treatment approved by the FDA in fifteen years, the company said on Monday.

Rapivab inhibits the enzyme neuraminidase, which is critical to the spread of influenza. It is designed for use in hospitalized patients.

A single 600 mg dose of Rapivab via intravenous infusion for 15 to 30 minutes is recommended for adults who have shown flu symptoms for no more than two days, the company said.

Roth Capital Partner analyst Ed Arce estimated a $120 million stockpiling order from the U.S. Department of Health and Human Services (HHS) in the first quarter of 2015.

Rapivab was developed under a $234.8 million contract from Biomedical Advanced Research and Development Authority of the HHS. It was granted an "emergency use authorization" during the October 2009 swine flu pandemic.

The drug was launched in Japan in January 2010 by Shionogi & Co Ltd under the name Rapiacta. Later that year, it received approval in South Korea to treat influenza, and for use against swine and bird flu.

BioCryst is also developing a broad-spectrum anti-viral, BCX4430, with the National Institute of Allergy and Infectious Diseases, for viruses that pose a threat to health and national security, including Ebola.

(c) Copyright Thomson Reuters 2014. Click For Restrictions - https://about.reuters.com/fulllegal.asp