BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has been informed by its partner, Green Cross Corp., that Green Cross has filed a New Drug Application (NDA) in South Korea to seek regulatory approval for intravenous (i.v.) peramivir to treat patients with influenza.
"Green Cross has rapidly prepared their regulatory filing, the second application of what we hope will be many for marketing approvals of peramivir," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "BioCryst is focused on completing the development of i.v. peramivir as a treatment for hospitalized patients with seasonal influenza in the U.S. Additionally, we continue to work with other governments and our global network of partners to provide i.v. peramivir as a treatment option in the event of another wave of severe influenza during the current H1N1 pandemic, and on an ongoing basis for future influenza seasons through traditional regulatory approvals."