BioCryst Pharmaceuticals 8-K 2006
BIOCRYST PHARMACEUTICALS, INC.
FOR IMMEDIATE RELEASE
BIOCRYST RECEIVES FDA FAST TRACK DESIGNATION FOR PERAMIVIR
Birmingham, Alabama January 17, 2006 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 FDAs 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).
BioCrysts lead product candidate, Fodosine, 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 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 has been granted Orphan Drug status by the U.S. Food and Drug Administration for three indications: T-cell non-Hodgkins 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 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 companys web site at http://www.biocryst.com.
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