RESEARCH TRIANGLE PARK, NC, USA I December 20, 2013 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA). BioCryst is seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S. for the treatment of acute uncomplicated influenza in adults. Peramivir is approved in Japan and Korea for the treatment of influenza.
In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission. The peramivir NDA submission includes results in over 2700 subjects treated with peramivir in 27 clinical trials.
“BioCryst’s first NDA filing represents an important milestone in the history of the company. We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States,” said Jon P. Stonehouse, President & Chief Executive Officer. “BioCryst is preparing to make peramivir available in the U.S. in time for the 2014-15 influenza season, in the event approval is received in that timeframe. We thank BARDA/HHS for enabling the successful completion of this program.”
BioCryst requested and was granted a small business waiver of the application fee for the peramivir NDA filing. The waiver confirmation was submitted with the NDA filing.
About Peramivir
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 which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains. Peramivir has been developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name RAPIACTA® to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more information about peramivir, please visit BioCryst’s Web site at http://www.biocryst.com/peramivir.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 118
RESEARCH TRIANGLE PARK, NC, USA I December 20, 2013 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA). BioCryst is seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S. for the treatment of acute uncomplicated influenza in adults. Peramivir is approved in Japan and Korea for the treatment of influenza.
In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission. The peramivir NDA submission includes results in over 2700 subjects treated with peramivir in 27 clinical trials.
“BioCryst’s first NDA filing represents an important milestone in the history of the company. We are excited about the potential approval of peramivir as an i.v. treatment option that could benefit influenza patients in the United States,” said Jon P. Stonehouse, President & Chief Executive Officer. “BioCryst is preparing to make peramivir available in the U.S. in time for the 2014-15 influenza season, in the event approval is received in that timeframe. We thank BARDA/HHS for enabling the successful completion of this program.”
BioCryst requested and was granted a small business waiver of the application fee for the peramivir NDA filing. The waiver confirmation was submitted with the NDA filing.
About Peramivir
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 which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains. Peramivir has been developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name RAPIACTA® to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more information about peramivir, please visit BioCryst’s Web site at http://www.biocryst.com/peramivir.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 118
