Peramivir (Neuraminidase Inhibitor)
Peramivir
Peramivir may address unmet needs in the treatment of influenza:
- According to the Centers for Disease Control and Prevention (CDC), every year in the United States more than 200,000 people are hospitalized due to influenza or its complications, and of this number about 36,000 people die each year
- For patients hospitalized with influenza, there are no anti-virals approved for treatment of patients with severe or complicated influenza
- Oral and inhaled administration are not suitable for a large portion of hospitalized patients
- For patients with uncomplicated influenza, the only approved anti-virals available are oral or inhaled
Peramivir is a potent, intravenously administered 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 $180 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, every year in the United States more than 200,000 people are hospitalized due to influenza or its complications, and of this number about 36,000 people die each year. 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. In January 2010, Shionogi announced that it had received marketing and manufacturing approval for i.v. peramivir to treat patients with influenza in Japan.
Green Cross Corp.
In June 2006, BioCryst and Green Cross Corp. entered an agreement to develop and commercialize peramivir in South 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 will conduct clinical trials with peramivir in South Korea and will share with BioCryst all data from these studies. While facilitating development of peramivir in South Korea, these trials will also add important data to BioCryst's clinical studies program. In January 2010, Green Cross announced that it had filed a New Drug Application (NDA) in South Korea to seek regulatory approval for i.v. peramivir to treat patients with influenza.
BioCryst has retained all of its development and commercialization right to peramivir worldwide except in Japan, Taiwan and South Korea where BioCryst has strategic partnerships with Shionogi & Co., Ltd. in Japan, and Green Cross in South Korea.
For further information regarding these partnerships please visit our Partners & Business Development page.
Peramivir Stockpiling Partnerships
In addition, BioCryst has established agreements with partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities for their territories outside of the U.S.
- Hikma Pharmaceuticals PLC for Middle East and North Africa (MENA) region, excluding Israel
- Merck Serono for Europe, Russia, Canada and Singapore
- moksha8 Pharmaceuticals, Inc. for Brazil and Mexico
- Neopharm Group for Israel
- NT Pharma Co., Ltd. for China
For further information regarding these peramivir stockpiling partnerships 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
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)
