Peramivir (Neuraminidase Inhibitor)

Peramivir is an antiviral agent that inhibits influenza virus neuraminidase, an enzyme that is critical to the spread of influenza within the host. Peramivir is an inhibitor of influenza A and B neuraminidases and certain strains of influenza viruses that may be resistant to available neuraminidase inhibitors but are susceptible to peramivir in laboratory tests. In January 2006, BioCryst received United States Food and Drug Administration ("FDA") Fast Track designation of peramivir injection. Currently being developed in both intramuscular and intravenous formulations. The availability of an intravenous neuraminidase inhibitor may be important in treating patients hospitalized with severe and potentially life-threatening influenza. Additionally, the availability of an injectable formulation of peramivir could ensure appropriate dosing which may be a concern with currently available oral or inhaled anti-influenza agents.

In September 2007, BioCryst Reported Preliminiary Results from a Phase II Clinical Trial of Intramuscular Peramivir in Subjects with Acute Influenza. Read the full release here:

Preliminary Results from a Phase II Clinical Trial of Peramivir in Subjects with Acute Influenza

BioCryst is also currently conducting a Phase II clinical trial studying an intravenous formulation of peramivir in hospitalized patients. That trial is designed to compare the efficacy and safety of intravenous peramivir to orally administered oseltamivir in patients who require hospitalization due to acute influenza.

BioCryst is advancing the clinical development of peramivir under terms of a contract from the U.S. Department of Health and Human Services ("DHHS") which on January 3, 2007, awarded BioCryst a $102.6 million, four-year contract to develop peramivir for the treatment of seasonal and life-threatening influenza. Funding from the contract will support Phase II and Phase III product development activities including manufacturing of clinical lots, process validation, clinical studies and other product approval requirements needed for U.S. licensure. Read the full press release here:

BioCryst Awarded $102.6 Million from U.S. Department of Health and Human Services to Develop Peramivir for Seasonal and Pandemic Influenza

BioCryst has retained all of its development and commercialization right to peramivir worldwide except in Japan, Taiwan and Korea where BioCryst has strategic partnerships with Shionogi & Co. in Japan, and Green Cross in Korea.

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. Read the full press release here:

BioCryst and Shionogi Establish Collaboration in Japan

In June, 2006 BioCryst and Green Cross 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, including H5N1. 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. Read the full press release here:

BioCryst and Green Cross Enter Agreement to Develop and Commercialize Peramivir in South Korea

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 Centers for Disease Control and Prevention, 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.

Avian influenza A viruses of H5N1 subtype are circulating among birds worldwide. The virus is considered extremely contagious in fowl. It is believed that all species of birds are susceptible to avian influenza, but domestic poultry, including chickens and turkeys, are among the most susceptible to the highly pathogenic strain. According to the World Health Organization, as of February 2009, more than 400 people in 15 countries have been infected with H5N1 avian influenza, of which over 250 have died. Almost all of these infections are believed to have resulted from contact with infected poultry.

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Peramivir

(Neuraminidase Inhibitor)

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Peramivir (Neuraminidase Inhibitor)

About Influenza