BioCryst Launches ORLADEYO™ (berotralstat) in Germany
June 03 2021 - 7:00AM
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today
announced that oral, once-daily ORLADEYO™ (berotralstat)
is now available for patients with a prescription in Germany.
ORLADEYO was approved by the European Medicines
Agency (EMA) on April 30, 2021 for the prevention of recurrent
hereditary angioedema (HAE) attacks in HAE patients 12 years and
older. The full European Summary of Product Characteristics (SMPC)
for ORLADEYO is available on the EMA website at
www.ema.europa.eu.
“We have an experienced team in place in Germany
that is excited and honored to bring the first oral, once daily
therapy to HAE patients in Europe,” said Charlie Gayer, chief
commercial officer of BioCryst. “Patients and physicians
across Europe have told us about the significant need for a
targeted oral therapy for HAE, and Germany is the first of many
upcoming European launches for ORLADEYO.”
About
ORLADEYO™
(berotralstat)ORLADEYO™ (berotralstat) is the
first and only oral therapy designed specifically to prevent
attacks of hereditary angioedema (HAE) in adult and pediatric
patients 12 years and older. One capsule of ORLADEYO per day
works to prevent HAE attacks by decreasing the activity of plasma
kallikrein.
About BioCryst
PharmaceuticalsBioCryst Pharmaceuticals discovers novel,
oral, small-molecule medicines that treat rare diseases in which
significant unmet medical needs exist and an enzyme plays a key
role in the biological pathway of the disease. Oral, once-daily
ORLADEYO™ (berotralstat) is approved in the United States, the
European Union, Japan and the United Kingdom for the prevention of
HAE attacks in adults and pediatric patients 12 years and older.
BioCryst has several ongoing development programs including
BCX9930, an oral Factor D inhibitor for the treatment of
complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the
treatment of fibrodysplasia ossificans progressiva, and
galidesivir, a potential treatment for Marburg virus disease and
Yellow Fever. RAPIVAB® (peramivir injection), a viral
neuraminidase inhibitor for the treatment of influenza, has
received regulatory approval in the U.S., Canada, Australia, Japan,
Taiwan and Korea. Post-marketing commitments for RAPIVAB are
ongoing. For more information, please visit the company’s website
at www.biocryst.com.
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 periodically
files 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; risks relating to government actions,
including that decisions and other actions relating to pricing and
reimbursements may not be taken when expected or at all, or that
the outcomes of such decisions and other actions may not be in line
with BioCryst’s current expectations; the commercial viability of
ORLADEYO, including its ability to achieve market acceptance; the
FDA, EMA, MHRA, PMDA 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 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,
all of which identify important factors that could cause the actual
results to differ materially from those contained in BioCryst’s
forward-looking statements.
BCRXW
Contact:InvestorsJohn Bluth+1 919
859 7910jbluth@biocryst.com
MediaCatherine Collier
Kyroulis+1 917 886 5586ckyroulis@biocryst.com
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