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BIRMINGHAM, Ala., Dec. 16 /PRNewswire-FirstCall/ -- BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has completed a
$30.0 million registered direct offering of 2,228,829 shares of its common
stock to a group of institutional investors including Kleiner Perkins Caufield
& Byers and Texas Pacific Group Ventures. The shares of common stock, priced
at $13.46 per share, were registered pursuant to BioCrysts shelf registration
statements that were declared effective by the Securities and Exchange
Commission on January 5, 2004 and September 20, 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20030414/BIOCRYSTLOGO)
About BioCryst
BioCryst Pharmaceuticals, Inc. designs, optimizes and develops novel drugs
that block key enzymes involved in cancer, cardiovascular diseases, autoimmune
diseases, and viral infections. BioCryst integrates the necessary disciplines
of biology, crystallography, medicinal chemistry and computer modeling to
effectively use structure-based drug design to discover and develop small
molecule pharmaceuticals.
BioCrysts lead product candidate, Fodosine(TM), is a transition-state
analog inhibitor of the target enzyme purine nucleoside phosphorylase (PNP).
The drug is currently in a Phase IIa trial for patients with T-cell leukemia
and a combination IV and oral Phase I pharmacokinetic trial in healthy
volunteers. Results of the Phase IIa and the Phase I pharmacokinetic trial
will assist in the design of a planned combination IV and oral Phase IIb
pivotal clinical trial in patients with T-cell leukemia. The Company has
requested a Special Protocol Assessment from the FDA for this planned trial.
Additionally, Fodosine(TM) is currently being studied in a Phase I trial with
an oral formulation in cutaneous T-cell lymphoma (CTCL) and a Phase II trial
in chronic lymphocytic leukemia (CLL). BioCryst also plans to initiate a Phase
I/II trial in B-cell acute lymphoblastic leukemia during 2005. Fodosine(TM)
has been granted Orphan Drug status by the U.S. Food and Drug Administration
for three indications: T-cell non-Hodgkins lymphoma, including CTCL; CLL and
related leukemias including T-cell prolymphocytic leukemia, adult T-cell
leukemia, and hairy cell leukemia; and for treatment of B-cell acute
lymphoblastic leukemia (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 August, 2005, BioCryst initiated a Phase Ib study with its second-
generation PNP inhibitor, BCX-4208, to evaluate the safety, tolerability and
pharmacokinetics of multiple oral doses of BCX-4208. In November, 2005
BioCryst announced it had entered into an exclusive licensing agreement with
Roche to develop and commercialize BCX-4208 for the prevention of acute
rejection in transplantation and for the treatment of autoimmune diseases.
Additionally, BioCryst has re-initiated clinical development of peramivir,
an inhibitor of influenza neuraminidase, with a focus on intravenous and
intramuscular delivery. Also, BioCryst has identified a clinical candidate,
BCX-4678, in its hepatitis C polymerase inhibitor program, and is advancing
this compound through preclinical testing with the goal of filing an IND in
early 2006. For more information about BioCryst, please visit the companys
web site at http://www.biocryst.com.
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 we may not be able to enroll the required number of
subjects in clinical trials of Fodosine(TM) or BCX-4208, that each of the
Phase IIa trial for patients with T-cell leukemia, Phase I trial of BCX-4208,
the Phase I trial of Fodosine(TM) for treatment of patients with cutaneous T-
cell lymphoma and the Phase II trial of Fodosine(TM) for advanced fludarabine-
refractory CLL may not be successfully completed, that BioCryst or its
licensees may not commence as expected additional trials with Fodosine(TM) and
with BCX-4208 or planned human trials with peramivir or BCX-4678, that
Fodosine(TM), BCX-4208, peramivir, BCX-4678 or any of our other product
candidates may not receive required regulatory clearances from the FDA, that
Phase IIa clinical trials of Fodosine(TM) may not show the drug is effective
over the 6-week period, that ongoing and future clinical trials may not have
positive results, that we may not be able to obtain a Special Protocol
Assessment or otherwise be able to complete successfully the Phase IIb trial
that is currently planned to be pivotal, that we may not be able to continue
future development of Fodosine(TM), BCX-4208, peramivir, BCX-4678 or any of
our other current development programs including tissue factor/factor VIIa,
that Fodosine(TM), BCX-4208, peramivir, BCX-4678 or our other 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
BioCrysts most recent Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, current reports on Form 8-K and the latest Form S-3 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) 444-4633
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