Navigation Links
Emergency Use Authorization Granted For BioCryst's Peramivir

BIRMINGHAM, Ala., Oct. 23 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA), in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), has issued an emergency use authorization (EUA) for the investigational anti-viral drug intravenous (i.v.) peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Specifically, i.v. peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an i.v. drug is clinically appropriate, based on one or more of the following reasons:

  1. the patient is not responding to either oral or inhaled anti-viral therapy, or
  2. when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
  3. for adults only, when the clinician judges i.v. therapy is appropriate due to other circumstances.

Additional information regarding the peramivir EUA is available on the Web at:

In advance of any U.S. Government order that may come from the ongoing request for proposal (RFP) negotiations, BioCryst has donated and transferred to the Department of Health and Human Services (HHS) an initial supply sufficient for 1,200 courses of i.v. peramivir 600 mg once-daily for five days. This transfer was made under the development contract with HHS to allow doctors and patients near-term access to the drug, and is separate from the RFP process.

"The issuance of this EUA is important because it makes peramivir a treatment option for physicians in the U.S. during the ongoing influenza health emergency," said Jon P. Stonehouse, Chief Executive Officer at BioCryst. "BioCryst has worked with HHS to enable the Government to rapidly deploy an initial supply of peramivir, and we are prepared to deliver more."

To prepare for peramivir orders that BioCryst may receive from the U.S. or other governments during this pandemic emergency, BioCryst is completing production of approximately 130,000 courses of i.v. peramivir and is prepared to make more, if required.

About Peramivir

Peramivir is an anti-viral agent that was discovered by BioCryst which 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 pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in patients with complicated and uncomplicated influenza. BioCryst's partner, Shionogi & Co., Ltd. is currently preparing to file for regulatory approval in Japan this year.

About BioCryst

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. 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 Limited validate its scientific foundation and the utility of its product candidates. For more information, please visit the Company's Web site at

Forward-Looking Statements

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 U.S. government and ex-U.S. governments may choose not to issue a request for peramivir to treat influenza or such requests, if any, may not result in an order or such order, if any, may not be profitable for BioCryst; that to the extent peramivir is used as a treatment for H1N1 flu (or other strains of flu), there can be no assurance that it will prove effective; that HHS may further condition, reduce or eliminate future funding of the peramivir program; that ongoing peramivir clinical trials or our peramivir program in general may not be successful; that our product candidates may not receive required regulatory clearances from the FDA; that ongoing and future pre-clinical 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 and partnerships 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 actual cash 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 (filed November 28, 2008), 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 our projections and forward-looking statements.

SOURCE BioCryst Pharmaceuticals, Inc.

SOURCE BioCryst Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. CareFusion Shipping Ventilators to CDC for National Emergency Preparedness
2. FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics Focus Diagnostics
3. New ALS Patient Simulator Advanced Provides Valuable Training for EMS Teams and In-Hospital Emergency Personnel
4. Video: EmFinders EmSeeQ(TM) Now Available to Locate Wandering Individuals in Emergency Situations Nationwide
5. National Investigational Trial for Emergency Stroke Care At CDH: One Illinois Hospital Tests New Device That May Reverse Brain Damage Up to 24 Hours After Stroke
6. Emergency Medicine Physicians Announces Six New Contracts With North Carolina Hospitals
7. Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma
8. USAID Provides $5M in Emergency Support as Swine Flu Spreads
9. New Study Suggests Cholesterol-Lowering Statins Reduce Severe Asthma Attacks that Result in Hospitalizations and Emergency Room Visits
10. DuPont Provides Technology for Washington Hospital Centers Emergency Department
11. Hospital Launches Landmark Emergency Medicine Project
Post Your Comments:
(Date:11/27/2015)... , Nov. 27, 2015 Research and ... the "Global Intrauterine Devices Market 2015-2019" report ... --> In this report, the author the ... devices market for 2015-2019. To calculate the market size, ... following type of products: Hormonal IUDs and copper IUDs. ...
(Date:11/26/2015)... , November 27, 2015 ... --> --> ... emergency response system (PERS) market ... for 5 years with APAC ... expected to see a high ...
(Date:11/26/2015)... , 26 november 2015 ... kondigt de geplande investering aan van ten ... de laboratoria en het mondiale hoofdkantoor in ... uitbreiding zal resulteren in extra kantoorruimte en ... aan de groeiende behoeften van de farmaceutische ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... , ... According to an article published November 13th on, ... D.C. revolved around the fact that proper dental care, both at-home and in the ... between periodontal disease (more commonly referred to as gum disease) and diabetes. According to ...
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss doctors has ... it. Surviving Mesothelioma has just posted the findings on the website. Click here ... the cases of 136 mesothelioma patients who were treated with chemotherapy followed by EPP ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... edition of USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, with ... digital component is distributed nationally, through a vast social media strategy and across ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for ... of Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
Breaking Medicine News(10 mins):