BIOCRYST BEGINS STUDY IN LEUKEMIA, LYMPHOMA PATIENTS

BioCryst Pharmaceuticals has initiated a pivotal trial of its lead oncology drug, Fodosine, in the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma. Initiation of this trial triggers a $5 million payment from Mundipharma International under the terms of the collaboration established in February 2006.

The Phase II multicenter, open-label, non-randomized, repeat-dose registration study will be conducted in accordance with a special protocol assessment (SPA) agreement between the FDA and BioCryst and will test a combination of intravenous and oral formulations of Fodosine. Designed to determine the rate of complete remission achieved with this regimen of Fodosine, the multinational trial will include sites in the United States, Eastern and Western Europe, and South America.

The trial is based on the encouraging results seen in earlier studies of Fodosine. Those data indicated Fodosine is safe, well tolerated and effective as a single-agent therapy.

Fodosine is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase. The drug is currently being studied in clinical trials for indications including T-cell leukemia, cutaneous T-cell lymphoma, B-cell acute lymphoblastic leukemia and chronic lymphocytic leukemia.

Under the terms of the partnership, Mundipharma has committed to fund 50 percent of costs, up to $10 million, on current trials of Fodosine to be conducted by BioCryst, as well as an additional $15 million to assist in the evaluation of Fodosine's therapeutic safety and efficacy profile. BioCryst may receive future event payments totaling $155 million, along with royalties on product sales of Fodosine by Mundipharma.