Peramivir Phase 2 Data for the Treatment of Outpatient Influenza to be Presented at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
BIRMINGHAM, Ala., October 20, 2008 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals and partner Shionogi & Co., Ltd. (Shionogi) today announced that positive Phase 2 data on peramivir, a potent neuraminidase inhibitor for the treatment of influenza, has been accepted as a late-breaker poster at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/ Infectious Diseases Society of America (IDSA) 46th annual meeting taking place from October 25 to October 28 in Washington, D.C. The study was conducted by BioCryst's development partner, Shionogi.
The poster titled, "A Double-Blind, Placebo-Controlled Study of Intravenous Peramivir in Acute Influenza Patients" (Poster Session # 302: Respiratory Viruses I: Influenza and RSV) will be presented on Tuesday, October 28 from 12:15 p.m. - 1:15 p.m. Eastern Time in Hall C by Dr. Shigeru Kohno, Dean, Nagasaki University Graduate School of Medicine and Professor, Infection Immunology Department, Nagasaki University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Peramivir is an antiviral agent that 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 viral strains that are resistant to currently available treatments and has been safely administered to healthy subjects at high dose levels. Peramivir is currently being studied in hospitalized and outpatient flu, utilizing either an intramuscular or intravenous formulation. BioCryst is currently conducting two Phase 2 studies with peramivir, a study in subjects with acute, uncomplicated influenza, and a study in subjects with acute serious or potentially life threatening influenza. BioCryst's partner, Shionogi & Co., Ltd., is preparing for a pivotal Phase 3 program with peramivir in subjects with influenza.
BioCryst is an integrated biopharmaceutical company utilizing crystallography and structure-based drug design to develop a deep pipeline of novel therapeutics targeting major illnesses. BioCryst is currently advancing investigational new drugs discovered in-house in late-stage clinical trials for influenza and lymphoma. In addition, the Company has a pre-clinical portfolio of novel compounds, directed against infectious, cardiovascular, and autoimmune disease targets, to create long-term sustainable value. The Company's strategic alliances with the U.S. Department of Health and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International Holdings Ltd. validate its scientific foundation and the utility of its product candidates. For more information, please visit the Company's Web site at www.biocryst.com.
Shionogi & Co., Ltd., one of Japan's largest research-based pharmaceutical companies, develops, manufactures, distributes, imports and exports pharmaceuticals and diagnostics. Shionogi aims to provide innovative medicines which make a positive contribution to world-wide health. For additional company information, please visit Shionogi on the World Wide Web at http://www.shionogi.co.jp.
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 our belief that many subjects in the Phase 2 clinical trials of peramivir did not receive adequate dosing by intramuscular injection may not be correct, that HHS and the Food & Drug Administration (FDA) may not agree with our analysis, that HHS may further condition, reduce or eliminate future funding of the peramivir program, that ongoing peramivir clinical trials may not be successful, that the peramivir program may not be successful, that the pivotal trial with forodesine HCl in cutaneous T-cell lymphoma (CTCL) may not meet its endpoint, that development and commercialization of forodesine HCl in CTCL may not be successful, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future preclinical and clinical development may not have positive results, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates, that our projected burn rate may not be consistent with our expectations, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. 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, most recent Registration Statement on Form S-3 (File No. 333-145638), Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
CONTACT: Stuart Grant, CFO of BioCryst Pharmaceuticals, +1-205-444-4600
Web site: http://www.shionogi.co.jp/
Ticker Symbol: (NASDAQ-NMS:BCRX)
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Posted: October 2008