BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced
the company has entered into an exclusive collaboration with Pint
Pharma GmbH to register and promote ORLADEYO® (berotralstat) in the
pan-Latin America (LATAM) region.
“We are pleased to join forces with Pint Pharma
to bring our oral, once-daily therapy to hereditary angioedema
patients in LATAM who are in need of a new treatment option. Pint
Pharma is the ideal partner for BioCryst based on the team’s deep
experience in rare diseases that spans multiple aspects of
commercialization and their established network across this
important region,” said Charlie Gayer, chief commercial officer of
BioCryst.
“Our partnership with BioCryst is significant
for Pint Pharma given the critical unmet need among HAE patients in
LATAM who are seeking an innovative treatment option for this
serious disease. ORLADEYO has successfully launched in multiple
markets across the globe, and we are privileged to leverage our
expertise to support BioCryst in introducing this prophylactic
therapy to the region,” said David Munoz, chief executive officer
and co-founder of Pint Pharma.
Under the terms of the agreement, Pint Pharma
will be responsible for obtaining and maintaining all marketing
authorizations and for commercializing ORLADEYO in the pan-LATAM
region.
Pint Pharma is an Austria-based pharmaceutical
company that has extensive experience developing, registering and
commercializing rare disease and specialty treatments throughout
Latin America and Europe.
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.
U.S. Indication and Important Safety
Information
INDICATIONORLADEYO® (berotralstat) is a
plasma kallikrein inhibitor indicated for prophylaxis to prevent
attacks of hereditary angioedema (HAE) in adults and pediatric
patients 12 years and older.
Limitations of useThe safety
and effectiveness of ORLADEYO for the treatment of acute HAE
attacks have not been established. ORLADEYO should not be used for
the treatment of acute HAE attacks. Additional doses or dosages of
ORLADEYO higher than 150 mg once daily are not recommended due to
the potential for QT prolongation.
IMPORTANT SAFETY INFORMATION
An increase in QT prolongation was observed at
dosages higher than the recommended 150 mg once-daily dosage and
was concentration dependent.
The most common adverse reactions (≥10% and
higher than placebo) in patients receiving ORLADEYO were abdominal
pain, vomiting, diarrhea, back pain, and gastroesophageal reflux
disease.
A reduced dosage of 110 mg taken orally once
daily with food is recommended in patients with moderate or severe
hepatic impairment (Child-Pugh B or C) and in patients taking
chronically administered P-glycoprotein (P-gp) or breast cancer
resistance protein (BCRP) inhibitors (eg, cyclosporine).
Berotralstat is a substrate of P-gp and BCRP.
P-gp inducers (eg, rifampin, St. John’s wort) may decrease
berotralstat plasma concentration, leading to reduced efficacy of
ORLADEYO. The use of P-gp inducers is not recommended with
ORLADEYO.
ORLADEYO at a dose of 150 mg is a moderate
inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a
narrow therapeutic index that are predominantly metabolized by
CYP2D6 or CYP3A4, appropriate monitoring and dose titration is
recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor.
Appropriate monitoring and dose titration is recommended for P-gp
substrates (eg, digoxin) when coadministering with ORLADEYO.
The safety and effectiveness of ORLADEYO in
pediatric patients <12 years of age have not been
established.
There are insufficient data available to inform
drug-related risks with ORLADEYO use in pregnancy. There are no
data on the presence of berotralstat in human milk, its effects on
the breastfed infant, or its effects on milk production.
To report SUSPECTED ADVERSE REACTIONS,
contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at
1-800-FDA-1088
or www.fda.gov/medwatch.
Please see
full Prescribing
Information.
About BioCryst Pharmaceuticals
BioCryst 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 and multiple global
markets. 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) is approved in the
U.S. and multiple global markets, with post-marketing commitments
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; the commercial viability of
ORLADEYO, including its ability to achieve market acceptance; the
results of BioCryst’s partnership with Pint Pharma may not meet
BioCryst’s current expectations; the FDA 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
Media Contact:Catherine
Collier Kyroulis+1 917 886 5586ckyroulis@biocryst.com
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