Healthcare Industry News:  influenza 

Biopharmaceuticals FDA

 News Release - January 17, 2006

BioCryst Receives FDA Fast Track Designation for Peramivir

BIRMINGHAM, Ala., Jan. 17 (HSMN NewsFeed) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX ) today announced that the U.S. Food and Drug Administration (FDA) has granted "fast track" designation for peramivir injection in the treatment of influenza infections, including highly virulent, life-threatening strains of influenza. Peramivir is an influenza neuraminidase inhibitor that, in preclinical studies, has shown potent, broad- spectrum activity against multiple strains of flu, including the H5N1 virus. On December 22, 2005, BioCryst announced that the FDA had given the company approval to begin human clinical trials using injectable peramivir.

The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. In correspondence with BioCryst, the FDA said that it agrees that the use of peramivir in the proposed indication of treatment of influenza infections, including highly virulent, life-threatening strains, meets the criterion of treating a serious life-threatening condition. Based on this conclusion, the FDA designated peramivir injection for influenza infection as a fast track product.

"The FDA's decision supports our belief in the potential of peramivir as an effective therapy for the treatment of influenza, including highly virulent, life-threatening strains like those associated with avian influenza," said Charles E. Bugg, Ph.D., Chairman and Chief Executive Officer of BioCryst. "We are initially developing the intravenous formulation of peramivir for the treatment of acutely ill influenza-infected patients and anticipate beginning Phase I clinical testing of the intravenous formulation early this quarter, at the NIH Clinical Center in Bethesda, Maryland. In addition, we are also conducting preclinical studies with intramuscular formulations, which will be directed initially at patients with seasonal influenza infections. We are pursuing both of these development programs in close collaboration with research groups at the National Institutes of Allergy and Infectious Diseases (NIAID) at the National Institute of Health (NIH)."

About BioCryst

BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases, and viral infections. BioCryst integrates the necessary disciplines of biology, crystallography, medicinal chemistry and computer modeling to effectively use structure-based drug design to discover and develop small molecule pharmaceuticals.

BioCryst's lead product candidate, Fodosine(TM), is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). The drug is currently in a Phase IIa trial for patients with T-cell leukemia and a combination IV and oral Phase I pharmacokinetic trial in healthy volunteers was recently completed. Results of the Phase IIa and the Phase I pharmacokinetic trial will assist in the design of a planned combination IV and oral Phase IIb pivotal clinical trial in patients with T-cell leukemia. The Company has requested a Special Protocol Assessment from the FDA for this planned trial. Additionally, Fodosine(TM) is currently being studied in a Phase I trial with an oral formulation in cutaneous T-cell lymphoma (CTCL), a Phase II trial in chronic lymphocytic leukemia (CLL) and a Phase I/II trial in B-cell acute lymphoblastic leukemia (B-ALL). Fodosine(TM) has been granted Orphan Drug status by the U.S. Food and Drug Administration for three indications: T-cell non-Hodgkin's lymphoma, including CTCL; CLL and related leukemias including T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for treatment of B-cell acute lymphoblastic leukemia (ALL). Additionally the FDA has granted "fast track" status to the development of Fodosine(TM) for the treatment of relapsed or refractory T-cell leukemia.

In August, 2005, BioCryst initiated a Phase Ib study with its second- generation PNP inhibitor, BCX-4208, to evaluate the safety, tolerability and pharmacokinetics of multiple oral doses of BCX-4208. In November, 2005 BioCryst announced it had entered into an exclusive licensing agreement with Roche to develop and commercialize BCX-4208 for the prevention of acute rejection in transplantation and for the treatment of autoimmune diseases.

Additionally, BioCryst has re-initiated clinical development of peramivir, an inhibitor of influenza neuraminidase, with a focus on intravenous and intramuscular delivery. Also, BioCryst has identified a clinical candidate, BCX-4678, in its hepatitis C polymerase inhibitor program, and is advancing this compound through preclinical testing with the goal of filing an IND in 2006. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com.

Forward-looking statements

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 we or our licensees may not be able to enroll the required number of subjects in clinical trials of Fodosine(TM) or BCX-4208, that each of the Phase IIa trial for patients with T-cell leukemia, Phase I trial of BCX-4208, the Phase I trial of Fodosine(TM) for treatment of patients with cutaneous T-cell lymphoma, the Phase I/II trial of Fodosine(TM) for treatment of patients with B-cell ALL and the Phase II trial of Fodosine(TM) for advanced fludarabine-refractory CLL may not be successfully completed, that BioCryst or its licensees may not commence as expected additional trials with Fodosine(TM) and with BCX-4208 or planned human trials with peramivir or BCX- 4678, that Fodosine(TM), BCX-4208, peramivir, BCX-4678 or any of our other product candidates may not receive required regulatory clearances from the FDA, that clinical trials of Fodosine(TM) may not show the drug is effective over the initial treatment period, that ongoing and future clinical trials may not have positive results, that we may not be able to obtain a Special Protocol Assessment or otherwise be able to complete successfully the Phase IIb trial that is currently planned to be pivotal, that we or our licensees may not be able to continue future development of Fodosine(TM), BCX-4208, peramivir, BCX-4678 or any of our other current development programs including tissue factor/factor VIIa, that Fodosine(TM), BCX-4208, peramivir, BCX-4678 or our other development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not reach favorable agreements with potential pharmaceutical and biotech partners for further development of its product candidates, 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, 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.


Source: BioCryst Pharmaceuticals

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