RESEARCH TRIANGLE PARK, N.C., Oct. 8, 2014 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that clinical trial results related to its investigational drug RAPIVAB (peramivir injection), an intravenous (I.V.) neuraminidase inhibitor for the treatment of influenza, will be presented at the IDWeek Conference in Philadelphia October 8-12, 2014.
Three posters will be presented on Friday, October 10:
- Poster 827 titled "The Efficacy of Single Dose Peramivir in Acute Uncomplicated Influenza; an Integrated Subject Level Meta-Analysis," by Richard Whitley, M.D. et al.
- Poster 1169 titled "Safety of Peramivir in Hospitalized Influenza," by Sylvia M. Dobo, M.D. et al.
- Poster 1171 titled "The Development of Influenza Virus Variants with Reduced Susceptibility Following Peramivir Treatment: An Analysis of Clinical and Post-Marketing Experience," by Phil Collis, Ph.D. et al.
The posters are available at the Company's peramivir publications page.
The New Drug Application (NDA) for the indication of treatment of acute uncomplicated influenza in adults is currently under regulatory review by the FDA, with a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014.
RAPIVAB is a potent, intravenously administered, investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of influenza infection. If approved, RAPIVAB would be the first and only one-dose intravenous treatment for acute, uncomplicated influenza in the U.S. In laboratory tests, RAPIVAB has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains. RAPIVAB was developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched 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 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.
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: oral inhibitors of plasma kallikrein for hereditary angioedema, including BCX4161 and several second generation compounds; peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and BCX4430, a broad spectrum viral RNA polymerase inhibitor. For more information, please visit the Company's website at www.BioCryst.com.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may not provide regulatory approval for any use of peramivir or that the approval may be limited; that regulatory or other issues with our manufacturer may impact peramivir approval or may impact the supply of peramivir in the event of regulatory approval; the Company may not be able to successfully commercialize peramivir; that peramivir may never be purchased by any government entity for stockpiling. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst's projections and forward-looking statements.
CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910 (investors) Mariann Caprino, FleishmanHillard, +1-917-242-1087 (media)