U.S. Government Exercises Option for Additonal Rapivab® for Strategic National Stockpile
September 26 2019 - 7:15AM
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 approved antiviral influenza therapy,
RAPIVAB
® (peramivir injection).
With the exercise of the second option, BioCryst
plans to deliver a total of 20,000 doses of RAPIVAB, which will add
approximately $14 million of non-dilutive capital to the company,
by the end of 2019.
The RAPIVAB purchase by the HHS Office of the
Assistant Secretary for Preparedness and Response will supply the
Strategic National Stockpile, the nation’s largest supply of
life-saving pharmaceuticals and medical supplies for use in a
public health emergency.
“RAPIVAB is an important antiviral with proven
benefits for influenza patients, and we appreciate the opportunity
to fulfill these orders for HHS as they support patients and our
national security,” said Jon Stonehouse, chief executive officer of
BioCryst.
“This $14 million in non-dilutive capital from
the U.S. government is important to BioCryst as we continue to
actively evaluate several additional opportunities to bolster our
balance sheet by the end of 2019 to support our exciting progress
across multiple programs,” Stonehouse added.
These orders are part of a $34.7 million
contract (Contract No. 75D301-18-C-02984) the Centers for Disease
Control and Prevention has awarded for the procurement of up to
50,000 doses of RAPIVAB® (peramivir injection)
over a five-year period.
About RAPIVAB (peramivir
injection)RAPIVAB (peramivir injection) is approved in the
United States for the treatment of acute uncomplicated influenza in
patients 2 years 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 2 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.
About BioCryst PharmaceuticalsBioCryst
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.
BioCryst has several ongoing development programs including
BCX7353, an oral treatment for hereditary angioedema; BCX9930, an
oral Factor D inhibitor for the treatment of complement-mediated
diseases; galidesivir, a potential treatment for Marburg virus
disease and Yellow Fever, and a preclinical program to develop oral
ALK-2 inhibitors for the treatment of fibrodysplasia ossificans
progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase
inhibitor for the treatment of influenza, is BioCryst's first
approved product and has received regulatory approval in the U.S.,
Canada, Australia, Japan, Taiwan, Korea and the European Union.
Post-marketing commitments for RAPIVAB are ongoing. For more
information, please visit the Company's website at
www.BioCryst.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding future results,
performance or achievements. These statements involve known and
unknown risks, uncertainties and other factors which may cause
BioCryst’s 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 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: that the U.S. government may purchase
smaller quantities of RAPIVAB® than currently anticipated, or none
at all; that the company 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
the company’s ability to supply RAPIVAB pursuant to the government
contract; and that government contracts contain certain terms and
conditions, including termination provisions, that subject the
company to additional risks. 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
projections and forward-looking statements.
BCRXW
Contact:John Bluth+1 919 859
7910jbluth@biocryst.com
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