>>BioCryst Initiates Pivotal Fodosine(TM) Phase IIb Clinical Trial in Patients With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma
Tuesday January 16, 7:30 am ET
BioCryst to Receive $5 Million Milestone Payment from Mundipharma
BIRMINGHAM, Ala., Jan. 16 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX - News) today announced that it has initiated a pivotal trial of its lead oncology drug, Fodosine(TM), in the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma. Initiation of this trial triggers a $5 million event payment from Mundipharma International Holdings Limited (Mundipharma) to BioCryst under the terms of the collaboration established in February, 2006 between the two companies to develop and commercialize Fodosine(TM), in markets across Europe, Asia, Australia and certain neighboring countries for use in oncology.
The multicenter, open-label, non-randomized, repeat-dose registration study will be conducted in accordance with a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration (FDA) and BioCryst and will test a combination of intravenous and oral formulations of Fodosine(TM). Designed to determine the rate of complete remission achieved with this regimen of Fodosine(TM), the multinational trial will include sites in the United States, Eastern and Western Europe, and South America.
"This pivotal trial is based on the encouraging results we have seen in earlier studies of Fodosine(TM), including the positive data reported recently at the 2006 American Society of Hematology Annual Meeting," said J. Claude Bennett, M.D., Chief Operating Officer of BioCryst. "Those data indicated Fodosine(TM) is safe, well tolerated and effective as a single agent therapy and we believe Fodosine(TM) has the potential to be a valuable addition in the treatment of patients with T-cell mediated diseases."
Fodosine(TM) is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP). The drug is currently being studied in clinical trials for indications including T-cell leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL).
"The initiation of this pivotal study represents a major advancement in the company's efforts to bring Fodosine(TM) to market," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "There is a great need for new treatment options in T-cell mediated leukemias and lymphomas and we are working aggressively to enroll patients into this trial and advance this novel product toward commercialization in collaboration with our partner, Mundipharma."
Under the terms of the partnership, Mundipharma has committed to fund 50% of costs, up to $10 million, on current trials of Fodosine(TM) to be conducted by BioCryst, as well as an additional $15 million to assist in the evaluation of Fodosine's(TM) therapeutic safety and efficacy profile. Including the milestone reported today and as part of the original agreement with Mundipharma, BioCryst may receive future event payments totaling $155 million, along with royalties on product sales of Fodosine(TM) by Mundipharma. BioCryst retains all rights to commercialize and promote Fodosine(TM) in the United States, and other countries outside the scope of this agreement. BioCryst will owe sublicense payments to third parties on this event payment.
About Mundipharma
Mundipharma is one of the Purdue/Mundipharma/Napp independent associated companies - privately owned companies and joint ventures covering the world's pharmaceutical markets. The companies worldwide are dedicated to bringing to patients with severe and debilitating diseases the benefits of novel treatment options in fields such as severe pain, haemato-oncology and respiratory disease. For more information: www.mundipharma.co.uk <<
snip
Cheers, Tuck |
