RESEARCH TRIANGLE PARK, NC, USA I May 01, 2018 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that the European Medicines Agency (EMA) has approved peramivir with the brand name of ALPIVAB, a single intravenous (I.V.) infusion for the treatment of uncomplicated influenza in adults and children from the age of 2 years.
“ALPIVAB approval in the European Union represents a significant advancement for influenza patients, representing the only single dose I.V. treatment option in the armamentarium for influenza infections,” said Jon P. Stonehouse, President & Chief Executive Officer.
The EMA’s approval of ALPIVAB under the centralized licensing procedure provides marketing authorization for all 28-member states of the European Union, Norway and Iceland. Previously, peramivir injection (RAPIVAB®, RAPIACTA®, PERAMIFLU®) has received approval for commercialization in the United States, Canada, Australia, Japan, Taiwan and Korea.
BioCryst has a license agreement with Seqirus regarding peramivir. As we have previously disclosed, BioCryst and Seqirus are engaged in a formal dispute resolution process. The dispute involves many items under the contract including, but not limited to, the EMA approval milestone of $5 million dollars, which BioCryst maintains is now due under the parties’ agreement.
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved in the United States for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule medicines that address both common and rare conditions. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for filoviruses, and a preclinical program to develop oral Alk-2 inhibitors for the treatment of fibrodysplasia ossificans progressive (FOP). RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at http://www.biocryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 24
RESEARCH TRIANGLE PARK, NC, USA I May 01, 2018 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that the European Medicines Agency (EMA) has approved peramivir with the brand name of ALPIVAB, a single intravenous (I.V.) infusion for the treatment of uncomplicated influenza in adults and children from the age of 2 years.
“ALPIVAB approval in the European Union represents a significant advancement for influenza patients, representing the only single dose I.V. treatment option in the armamentarium for influenza infections,” said Jon P. Stonehouse, President & Chief Executive Officer.
The EMA’s approval of ALPIVAB under the centralized licensing procedure provides marketing authorization for all 28-member states of the European Union, Norway and Iceland. Previously, peramivir injection (RAPIVAB®, RAPIACTA®, PERAMIFLU®) has received approval for commercialization in the United States, Canada, Australia, Japan, Taiwan and Korea.
BioCryst has a license agreement with Seqirus regarding peramivir. As we have previously disclosed, BioCryst and Seqirus are engaged in a formal dispute resolution process. The dispute involves many items under the contract including, but not limited to, the EMA approval milestone of $5 million dollars, which BioCryst maintains is now due under the parties’ agreement.
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved in the United States for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule medicines that address both common and rare conditions. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, galidesivir, a potential treatment for filoviruses, and a preclinical program to develop oral Alk-2 inhibitors for the treatment of fibrodysplasia ossificans progressive (FOP). RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at http://www.biocryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 24
