Biocryst Pharmaceuticals Initiates Pivotal Fodosine(TM) Phase IIb Clinical Trial In Patients With Relapsed/Refractory T-Lymphoblastic Leukemia/Lymphoma
BIRMINGHAM, Ala., Jan. 16 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. 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.
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
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including Fodosine(TM) in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization BCX-4208, and is collaborating with Mundipharma for the development and commercialization of Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com .
These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that DHHS could reduce or eliminate funding for peramivir, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future clinical trials may not have positive results, that we may not be able to complete successfully the Phase IIb trial for Fodosine(TM) that is currently planned to be pivotal, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not reach favorable agreements with potential pharmaceutical and biotech partners for further development of its product candidates, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
Contact: BioCryst Pharmaceuticals, Inc. Jonathan M. Nugent V.P. Corporate Communications (205) 444-4633BioCryst Pharmaceuticals, Inc.
CONTACT: Jonathan M. Nugent, V.P. Corporate Communications of BioCrystPharmaceuticals, Inc., +1-205-444-4633