BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that following the
favorable opinion of the European Committee for Orphan Medicinal Products
(COMP), the European Medicines Agency (EMEA) has granted an "Orphan
Medicinal Product Designation" for the anticancer drug Fodosine(TM) for the
treatment of T-Cell Acute Lymphoblastic Leukemia (T-Cell ALL).
The EMEA's "Orphan Medicinal Product Designation" is designed to
promote the development of drugs which may provide "significant benefit" to
patients suffering from rare diseases identified as "life-threatening or
very serious." Under EMEA guidelines, Orphan Medicinal Product Designation
provides 10 years of potential market exclusivity if the product candidate
is approved for marketing in the European Union. Orphan status also permits
EMEA assistance in optimizing the candidate's clinical development through
participation in designing the clinical protocol and preparing the
marketing application. Additionally, a drug candidate designated by the
EMEA as an Orphan Medicinal Product may qualify for a reduction in
regulatory fees as well as a European Union-funded research grant.
"The EMEA's decision to grant Fodosine(TM) Orphan Drug Status is an
important milestone as we continue to make significant strides to develop
and commercialize Fodosine(TM) in North America and in close collaboration
with our partner in Europe, Mundipharma, simultaneously advance
Fodosine(TM) toward commercialization in Europe," said Charles E. Bugg,
Ph.D., Chairman and CEO of BioCryst. "We are gratified by this decision
which should accelerate the path to potential marketing approval for
Fodosine(TM) in Europe."
In 2005, the United States Food and Drug Administration (FDA) granted
Orphan Drug designation to Fodosine(TM) for three indications: T-cell non-
Hodgkin's lymphoma, including CTCL; CLL and related leukemias including
T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell
leukemia; and for the treatment of B-ALL. Additionally the FDA has granted
"fast track" status to the development of Fodosine(TM) for the treatment of
relapsed or refractory T-cell leukemia.
In early 2006, BioCryst entered into a strategic collaboration with
Mundipharma International Holdings Limited to develop and commercialize
Fodosine(TM) in markets across Europe, Asia, Australia and certain
neighboring countries for use in oncology.
About Fodosine(TM)
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). BioCryst is in the
process of initiating a Phase IIb pivotal clinical trial of Fodosine(TM) in
the treatment of patients who have failed two or more previous therapies
for T-cell leukemia.
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, peramivir in
seasonal and life- threatening influenza, and BCX-4678 in hepatitis C.
BioCryst has a worldwide partnership with Roche for the development and
commercialization BCX-4208 and is collaborating with Mundipharma Holdings
for the development and commercialization of Fodosine(TM) in markets across
Europe, Asia, Australia and certain neighboring countries. For more
information about BioCryst, please visit the Company's web site at
biocryst.
Forward-looking statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. 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 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 or foreign regulatory authorities, 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) pursuant to the Special
Protocol Assessment letter 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 or governmental agencies 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,
and the risks, uncertainties and factors identified in the documents
BioCryst files periodically with the Securities and Exchange Commission,
specifically including BioCryst's most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, current reports on Form 8-K. These
statements reflect our current views with respect to future events and
BioCryst has no obligation to update or revise the statements. BioCryst
cautions that you should not place undue reliance on these forward-looking
statements.
BioCryst Pharmaceuticals, Inc.
biocryst