BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) 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:
mundipharma.
About BioCryst
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 biocryst.
Forward-looking statements
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.
BioCryst Pharmaceuticals, Inc.
biocryst