Peramivir (Neuraminidase Inhibitor)
| At this time, peramivir is available in the U.S. only through participation in the ongoing Phase 3 studies. You can find details regarding these studies on the web at clinicaltrials.gov, including enrollment eligibility and U.S. investigator sites. Links to the studies are available from the BioCryst website clinical trials page. If you require more information about access to peramivir than is currently available on these websites, please call 1-205-989-3262. |
Peramivir
Peramivir is approved in Japan and Korea, and may address unmet needs in the treatment of influenza:
- According to the Centers for Disease Control and Prevention (CDC), an estimated 5% to 20% of the American population suffers from influenza annually, and there are approximately 3,000 to 49,000 flu-related deaths per year in the U.S.
- For patients hospitalized with influenza outside Japan & Korea, there are no injectable anti-virals approved for treatment of patients with severe or complicated influenza
- For patients with uncomplicated influenza outside Japan & Korea, the only approved anti-virals available are oral or inhaled formulations
Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme that is critical to the spread of influenza within the host. Peramivir is an inhibitor of influenza A and B viruses, including strains of influenza viruses that may be resistant to available neuraminidase inhibitors. In January 2006, BioCryst received United States Food and Drug Administration (FDA) Fast Track designation for peramivir. The availability of an intravenous (i.v.) neuraminidase inhibitor may be important in treating patients hospitalized with severe and potentially life-threatening influenza by ensuring that the appropriate dose is administered, which may be a concern with currently available oral or inhaled anti-influenza agents.
Peramivir currently is being developed under a $234.8 million contract from the Biomedical Advanced Research and Development Authority (BARDA) within the United States Department of Health and Human Services (HHS).
About Influenza
The influenza virus causes an acute viral disease of the respiratory tract. Unlike the common cold and some other respiratory infections, seasonal flu can cause severe illness, resulting in life-threatening complications. According to the CDC, an estimated 5% to 20% of the American population suffers from influenza annually, and there are approximately 3,000 to 49,000 flu-related deaths per year in the U.S. Most at risk are young children, the elderly and people with seriously compromised immune systems.
Corporate Partnerships
Shionogi & Co., Ltd.
In March 2007, BioCryst and Shionogi & Co., Ltd. entered into an exclusive license agreement to develop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening human influenza. This agreement further validates the therapeutic potential and commercial viability of peramivir in the treatment of influenza. Currently, i.v. peramivir is marketed in Japan under the commercial name RAPIACTA® for the treatment of adults, children and infants with influenza.
Green Cross Corporation
In June 2006, BioCryst and Green Cross Corp. entered into an agreement to develop and commercialize peramivir in Korea. The agreement is part of BioCryst's strategy to accelerate peramivir development for the treatment of life-threatening strains of flu. Under the terms of the agreement, Green Cross Corp. conducted clinical trials with peramivir in Korea. In August 2010, Green Cross Corp. announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including pandemic H1N1 and avian influenza. Green Cross Corp. intends to launch peramivir under the commercial name PeramiFlu® in Korea.
BioCryst has retained all of its development and commercialization right to peramivir worldwide except in Japan, Taiwan, and Korea.
For further information regarding these partnerships please visit our Partners & Business Development page.
Clinical Trials
To learn more about our current studies visit our Clinical Trials page or visit clinicaltrials.gov.
Resources
Peramivir Scientific Publications
For more information on influenza, please visit the following websites:
- The Centers for Disease Control and Prevention
- National Institute of Allergy and Infectious Diseases at the National Institutes of Health
- The World Health Organization (WHO)
