BioCryst signs Fodosine license agreement with Mundipharma

By Ted A. Knutson

Washington, Feb. 2 - BioCryst Pharmaceuticals, Inc. and Mundipharma International Holdings Ltd. announced Thursday they have entered into an exclusive license agreement to develop and commercialize BioCryst's lead compound, Fodosine, in markets across Europe, Asia and Australasia for use in oncology.

Fodosine is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). The drug is being studied in a number of clinical trials including a phase 2a clinical trial in patients with T-cell leukemia.

Results of this trial and those from a recently completed phase 1 pharmacokinetic study will assist in the design of a planned phase 2b pivotal clinical trial to test a combination of IV and oral formulations of Fodosine in patients with T-cell leukemia.

BioCryst has requested a special protocol assessment from the Food and Drug Administration for this planned trial.

Under the terms of the agreement Mundipharma will obtain rights in markets across Europe, Asia and Australasia to Fodosine in the field of oncology in exchange for a $10 million up-front payment.

Mundipharma will pay 50% of costs, up to an additional $10 million, on current trials of Fodosine and on the planned phase 2b trial to be conducted by BioCryst.

Mundipharma also will commit up to an additional $15 million to assist in the evaluation of Fodosine's therapeutic safety and efficacy profile.

BioCryst may also receive future event payments totaling $155 million in addition to royalties on product sales of Fodosine by Mundipharma.

BioCryst will owe sublicense payments to third parties on the upfront payment and any future event payments and royalties on this PNP.

For the next five years after the effective date of this alliance between Mundipharma and BioCryst, Mundipharma will have a right of first negotiation on any new PNP inhibitors BioCryst elects to develop in the area of oncology, except for the BioCryst compound BCX-4208.

BioCryst retains all rights to commercialize and promote Fodosine in the United States and other countries outside the scope of this agreement.

Birmingham, Ala.-based BioCryst designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases and viral infections.

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