BioCryst Launches ORLADEYO® (berotralstat) in Spain
21 Novembre 2023 - 1:00PM
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that
the Spanish Ministry for Health (Ministerio de Sanidad) has
granted marketing authorization for oral, once-daily
ORLADEYO® (berotralstat) for the routine prevention of
recurrent hereditary angioedema (HAE) attacks in HAE patients 12
years and older.
“We have an experienced and motivated team in
Spain that is enthusiastic about the impact the availability of the
first oral, once daily therapy can have for people with HAE in
Spain,” said Charlie Gayer, chief commercial officer of BioCryst.
“Spanish patients and physicians have shared with us the need to
expand treatment options and we are excited now to be in a position
to support access to those who can benefit most.”
About BioCryst
PharmaceuticalsBioCryst Pharmaceuticals is a global
biotechnology company with a deep commitment to improving the lives
of people living with complement-mediated and other rare diseases.
BioCryst leverages its expertise in structure-guided drug design to
develop first-in-class or best-in-class oral small-molecule and
protein therapeutics to target difficult-to-treat rare diseases.
BioCryst has commercialized ORLADEYO® (berotralstat), the first
oral, once-daily plasma kallikrein inhibitor, and is advancing a
pipeline of small-molecule and protein therapies. For more
information, please visit www.biocryst.com or follow us on
LinkedIn.
Forward-Looking StatementsThis
press release contains forward-looking statements, including
statements regarding BioCryst’s plans and expectations for
ORLADEYO. These statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance 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 are 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: the
ongoing COVID-19 pandemic, which could create challenges in all
aspects of BioCryst’s business, including without limitation
delays, stoppages, difficulties and increased expenses with respect
to BioCryst’s and its partners’ development, regulatory processes
and supply chains, negatively impact BioCryst’s ability to access
the capital or credit markets to finance its operations, or have
the effect of heightening many of the risks described below or in
the documents BioCryst files periodically with the Securities and
Exchange Commission; BioCryst’s ability to successfully implement
its commercialization plans for, and to commercialize, ORLADEYO,
which could take longer or be more expensive than planned; the
commercial viability of ORLADEYO, including its ability to achieve
market acceptance; the FDA, Spanish Ministry for Health, or other
applicable regulatory agency may require additional studies beyond
the studies planned for products and product candidates, may not
provide regulatory clearances which may result in delay of planned
clinical trials, may impose certain restrictions, warnings, or
other requirements on products and product candidates, may impose a
clinical hold with respect to product candidates, or may withhold,
delay, or withdraw market approval for products and product
candidates; BioCryst’s ability to successfully manage its growth
and compete effectively; risks related to the international
expansion of BioCryst’s business; and actual financial results may
not be consistent with expectations, including that revenue,
operating expenses and cash usage may not be within management's
expected ranges. 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, and Current Reports on Form 8-K,
which identify important factors that could cause the actual
results to differ materially from those contained in BioCryst’s
forward-looking statements.
BCRXW
Investor Contact:John Bluth+1 919 859
7910jbluth@biocryst.com
Press Contact:Niamh Lyons+353
87 774 5000nlyons@biocryst.com
BioCryst Pharmaceuticals (NASDAQ:BCRX)
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