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BioCryst uses structure-based drug design, which incorporates multiple scientific disciplines including biology, crystallography, medicinal chemistry and computer modeling, in order to most efficiently develop new therapeutic candidates.

BioCryst's Approach to Building its Product Pipeline

BioCryst designs drug candidates using detailed knowledge of the structures of active sites of targeted enzymes. The active site of an enzyme is the area into which a chemical or biological molecule fits to initiate a biochemical reaction. Enzymes make ideal drug targets as they mediate biochemical processes along disease pathways, are relatively easy to crystallize, and have small active sites. BioCryst aims to license or design compounds that will fit in the active sites of enzymes and thereby interfere with the progression of disease. Using this approach, the company has successfully both licensed and designed product candidates for cancer, autoimmune diseases, cardiovascular diseases and viral infections.

Business Strategy

Our business strategy is to increase the value of our drug candidate portfolio. We believe this is best achieved by retaining full product rights to drug product candidates within specialty markets, while relying on collaborative arrangements with third parties for drug product candidates within larger markets or outside our area of expertise. Potential third party alliances could include preclinical development, clinical development, regulatory approval, marketing, sales and distribution of our drug product candidates.

The Company uses strategic alliances early in the drug identification process through in-licensing of drug targets. BioCryst currently has collaborations with leading academic organizations including The University of Alabama at Birmingham, Emory University, Albert Einstein College of Medicine and Industrial Research, Ltd. (New Zealand). We have established collaborative relationships for development and commercialization of product candidates in their respective territories as follows:

• Mundipharma International Holdings Limited for forodesine HCl in Europe, Asia and Australia;
• Shionoigi & Co. Ltd. for peramivir in Japan; and         
• Green Cross Corporation for peramivir in Korea        

Market Opportunity

BioCryst primarily focuses its product development efforts on cancer, autoimmune diseases, and viral infections; therapeutic areas that are all large and growing. The following information provides an overview of the company's clinical development programs.

Peramivir

According to the U.S. Centers for Disease Control and Prevention, an estimated 5% to 20% of the American population suffers from influenza annually, more than 200,000 people are hospitalized from flu complications, and approximately 36,000 people die. Peramivir is our neuraminidase inhibitor in development for the treatment of acute influenza, including infection caused by highly virulent, life-threatening strains of influenza such as avian influenza. This product is currently in development with two formulations, intravenous and intramuscular. In January 2007, we announced tht the U.S. Department of Health and Human Services had awarded us a $102.6 million, four year contract for the advanced development of peramivir. Funding from the contract will support manufacturing of clinical lots, process validation, clinical studies and other U.S. product approval requirements. In addition, we have licensed peramivir to Shionogi & Co., Ltd. for development and commercialization in Japan and Tawain and to Green Cross Corporation for development and commercialization in Korea.

Forodesine HCl (BCX-1777)

Our advanced drug candidate, forodesine HCl, is an investigational purine nucleoside phosphorylase (PNP) inhibitor for the treatment of T- and B-cell mediated disorders. PNP is an enzyme that plays a key role in T- and B-cell proliferation and inhibiting this enzyme provides a novel mechanism for inhibiting T- and B-cell proliferation. Typically, T- and B-cells are an essential part of the body's immune system, but when they multiply uncontrollably they can cause various forms of cancer. Inhibiting PNP produces selective suppression of T- and B-cells. We have received Special Protocol Assessments from the U.S. Food and Drug Administration (FDA) for forodesine HCl to conduct pivotal clinical trials in cutaneous T-cell lymphoma (CTCL) with an oral formulation. Forodesine HCl has been granted Orphan Drug status by the FDA for three indications, T-cell non-Hodgkin's lymphoma (including CTCL), CLL and B-ALL.

BCX-4208/R3421

BCX-4208/R3421 is a second generation PNP inhibitor with broad applications in autoimmune diseases.

 

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