U.S. Government Exercises Option to Purchase Additional RAPIVAB® (peramivir injection) from BioCryst for Pandemic Influenza Preparedness
August 25 2022 - 7:00AM
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that
the U.S. Department of Health and Human Services (HHS) has
exercised its option to purchase an additional 10,000 doses of
BioCryst’s antiviral influenza therapy, RAPIVAB® (peramivir
injection), for approximately $7 million.
The RAPIVAB purchase by the HHS Administration
for Strategic Preparedness and Response will strengthen the
nation’s preparedness to respond to a potential pandemic influenza
event.
The order is the final of five purchase options
from a $34.7 million contract (Contract No. 75D301-18-C-02984) the
Centers for Disease Control and Prevention awarded in 2018 for the
procurement of up to 50,000 doses of
RAPIVAB over a five-year period. With the
fulfillment of this new order, BioCryst will have delivered all
50,000 doses to HHS under the contract.
About RAPIVAB®
(peramivir injection)RAPIVAB® (peramivir
injection) is approved in the United States for the treatment of
acute uncomplicated influenza in patients six months and older who
have been symptomatic for no more than two days. It is administered
via an intravenous infusion for a minimum of 15 minutes at
recommended doses of 600 mg/kg for adults and adolescents and 12
mg/kg for pediatric patients ages six months to 12 years. Efficacy
of RAPIVAB is based on clinical trials of naturally occurring
influenza in which the predominant influenza infections were
influenza A virus and a limited number of patients infected with
influenza B virus. Visit http://www.rapivab.com to learn
more.
U.S. Indication and Important Safety
Information
IndicationRAPIVAB is indicated
for the treatment of acute uncomplicated influenza in patients 6
months and older who have been symptomatic for no more than 2
days.
Limitations of Use
- Efficacy of RAPIVAB is based on
clinical trials of naturally occurring influenza in which the
predominant influenza infections were influenza A virus; a limited
number of subjects infected with influenza B virus were
enrolled.
- Influenza viruses change over time.
Emergence of resistance substitutions could decrease drug
effectiveness. Other factors (for example, changes in viral
virulence) might also diminish clinical benefit of antiviral drugs.
Prescribers should consider available information on influenza drug
susceptibility patterns and treatment effects when deciding whether
to use RAPIVAB.
- The efficacy of RAPIVAB could not
be established in patients with serious influenza requiring
hospitalization.
ContraindicationsRAPIVAB is
contraindicated in patients with known serious hypersensitivity or
anaphylaxis to peramivir or any component of the product. Severe
allergic reactions have included anaphylaxis, erythema multiforme
and Stevens-Johnson Syndrome.
Warnings and Precautions
- Cases of anaphylaxis and serious
skin/hypersensitivity reactions such as Stevens-Johnson syndrome
and erythema multiforme have occurred with RAPIVAB. Discontinue
RAPIVAB and initiate appropriate treatment if anaphylaxis or
serious skin reaction occurs or is suspected.
- Neuropsychiatric events: Patients
with influenza may be at an increased risk of hallucinations,
delirium and abnormal behavior early in their illness. Monitor for
signs of abnormal behavior.
- Serious bacterial infections may
begin with influenza-like symptoms or may coexist with or occur as
complications during the course of influenza. RAPIVAB has not been
shown to prevent such complications.
Adverse ReactionsThe most
common adverse reaction in adults (18 years of age and older) was
diarrhea (8% RAPIVAB vs 7% placebo). Lab abnormalities (incidence
≥2%) occurring more commonly with RAPIVAB than placebo were
elevated ALT > 2.5 times the upper limit of normal (3% vs 2%),
elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at
least 6 times the upper limit of normal (4% vs 2%), and neutrophils
<1.0 x 109/L (8% vs 6%). In a subset of subjects with serious
influenza requiring hospitalization treated with RAPIVAB 600 mg as
monotherapy (N=101), the following adverse reactions were also
reported more frequently with RAPIVAB as compared to placebo:
constipation (4% versus 2%), insomnia (3% versus 0%), AST increased
(3% versus 2%), and hypertension (2% versus 0%).
The safety profile of RAPIVAB in subjects 6
months to 17 years of age was generally similar to that observed in
adults. The only adverse reaction reported in pediatric subjects
treated with RAPIVAB (occurring in ≥2% of subjects) and not
reported in adults was vomiting (3% versus 9% for oseltamivir). The
only clinically significant laboratory abnormality (DAIDS Grade 2)
occurring in ≥2% of pediatric subjects treated with RAPIVAB (and
not previously reported in adults) was proteinuria by dipstick
analysis (3% versus 0% for oseltamivir).
Concurrent Use With Live Attenuated
Influenza VaccineAntiviral drugs may inhibit viral
replication of a live attenuated influenza vaccine (LAIV) and thus
may reduce vaccine efficacy. The concurrent use of RAPIVAB with
LAIV intranasal has not been evaluated. Avoid use of LAIV within 2
weeks before or 48 hours after administration of RAPIVAB, unless
medically indicated.
Please see full
prescribing information for
RAPIVAB.You are encouraged to report negative side effects
of prescription drugs to the FDA. To report suspected adverse
reactions, contact BioCryst Pharmaceuticals at 1-833-633-2279 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 sales of RAPIVAB. These statements involve
known and unknown risks, uncertainties and other factors which may
cause BioCryst’s actual results to be materially different from
those 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: BioCryst relies on third-party manufacturers to
manufacture RAPIVAB in a timely manner and in accordance with
applicable governmental regulations, and any failure of such
third-party manufacturers to perform their obligations could impact
BioCryst’s ability to supply RAPIVAB pursuant to its government
procurement contract; government contracts contain certain terms
and conditions that subject BioCryst to additional risks; and 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’ supply chains, negatively
impact BioCryst’s ability to access the capital or credit markets
to finance its operations, or have the effect of heightening the
other risks described herein or in the documents BioCryst files
periodically with the Securities and Exchange Commission. 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
Investors:John
Bluth+1 919 859 7910jbluth@biocryst.com
Media:Catherine Collier
Kyroulis+1 917 886 5586ckyroulis@biocryst.com
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