TARRYTOWN, N.Y., Sept. 14, 2021 /PRNewswire/ --
New agreement for 1.4 million doses of REGEN-COV, brings
total purchased by the U.S. government to nearly 3 million
doses
REGEN-COV currently authorized to treat certain infected
patients to reduce risk of hospitalization or death from COVID-19,
and for post-exposure prophylaxis for close contacts of infected
individuals
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced that the U.S. Department of Health and Human
Services (HHS) and the Department of Defense (DOD) will purchase
1.4 million additional doses of REGEN-COV (casirivimab and
imdevimab). The government will continue to provide REGEN-COV at no
cost to patients.
"More than a year and a half into this pandemic, too many people
are still being hospitalized and dying due to COVID-19," said
Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer of Regeneron. "While
vaccination remains the first line of defense to decrease the
burden of COVID-19, REGEN-COV is a key tool that reduces the risk
of hospitalization or death by 70% in high-risk individuals when
given early in the course of the infection. Recently there has been
greater demand for REGEN-COV, and we will provide additional doses
to the U.S. government as quickly as possible."
Under the new agreement, Regeneron will supply an additional 1.4
million 1,200 mg doses of REGEN-COV to the U.S. government by
January 31, 2022, at a cost of
$2,100 per dose. This new
agreement follows two earlier agreements with the U.S. government
announced in July 2020 and
January 2021.
REGEN-COV is an investigational medicine authorized by the U.S.
Food and Drug Administration (FDA) under an emergency use
authorization to treat people who are at high risk of serious
consequences from COVID-19 infection who are either already
infected (non-hospitalized) or in certain post-exposure
prophylaxis settings.
In addition, the robust REGEN-COV development program has
reported positive Phase 3 trial results across the spectrum of
COVID-19 infection, from prevention to hospitalization:
- Prevention of symptomatic infection in asymptomatic household
contacts (both uninfected and infected) of SARS-CoV-2 infected
individuals
- Treatment of non-hospitalized patients already infected with
SARS-CoV-2
- Treatment of certain patients hospitalized due to COVID-19
infection, including the UK RECOVERY trial
The development and manufacturing of REGEN-COV have been funded
in part with federal funds from the Biomedical Advanced Research
and Development Authority (BARDA), part of the HHS's Office of the
Assistant Secretary for Preparedness and Response, under OT number:
HHSO100201700020C.
Regeneron invented REGEN-COV and is collaborating with
Roche to increase global supply, with Roche primarily responsible
for development and distribution outside the U.S.
Details of the Agreement
Regeneron expects to begin
delivering the additional REGEN-COV doses to the U.S. government in
September, with the vast majority delivered in Q4 2021. Regeneron
will record all net sales associated with this agreement. Pursuant
to a prior agreement, Roche will manufacture approximately one
third of the doses for Regeneron to fulfill this new agreement with
the U.S. government.
About the REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab and imdevimab) is a cocktail of two monoclonal
antibodies that was designed specifically to block infectivity of
SARS-CoV-2, the virus that causes COVID-19, using Regeneron's
proprietary VelocImmune® and
VelociSuite® technologies. The two potent,
virus-neutralizing antibodies that form the cocktail bind
non-competitively to the critical receptor binding domain of the
virus's spike protein, which diminishes the ability of mutant
viruses to escape treatment and protects against spike variants
that have arisen in the human population, as detailed
in Cell and Science.
Multiple analyses have shown that the antibody cocktail retains
potency against the main variants of concern circulating within the
U.S., including Delta (first identified in India), Gamma (first identified in
Brazil), Beta (first identified in
South Africa) and Mu (first
identified in Colombia), with
information available in the Fact Sheet for Healthcare Providers.
Consequently, REGEN-COV remains available for use across the U.S.,
and Regeneron will continue actively monitoring the potency of
REGEN-COV against emerging variants.
REGEN-COV has not been approved by the FDA, but is currently
authorized for treatment and post-exposure prophylaxis in
certain high risk individuals. Post-exposure prophylaxis with
REGEN-COV is not a substitute for vaccination against COVID-19.
REGEN-COV is not authorized for pre-exposure prophylaxis for
prevention of COVID-19 or for use in patients who are hospitalized
due to COVID-19 or require oxygen therapy, or for people currently
using chronic oxygen therapy because of an underlying comorbidity
who require an increase in baseline oxygen flow rate due to
COVID-19. This authorization is for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency uses under section 564(b)(1) of the Act, 21 U.S.C. §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner. Additional information about REGEN-COV in the U.S. is below
(authorized uses and important safety information).
In August, Regeneron submitted the first of two Biologics
License Applications (BLAs) for REGEN-COV. The initial submission
included data on the efficacy and safety of REGEN-COV to treat and
prevent SARS-CoV-2 infection in non-hospitalized people. The second
BLA submission will focus on those hospitalized because of
COVID-19, and is expected to be completed later this year.
Emergency or temporary pandemic use authorizations are currently
in place in more than 35 countries, including the U.S., several
European Union countries, India,
Switzerland and Canada, and the antibody cocktail is fully
approved in Japan.
Regeneron and Roche share a commitment to making the antibody
cocktail available to COVID-19 patients around the globe and will
support access in low- and lower-middle-income countries through
drug donations to be made in partnership with public health
organizations.
About Regeneron's VelocImmune
Technology
Regeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's President and
Chief Scientific Officer George D.
Yancopoulos was a graduate student with his mentor
Frederick W. Alt in 1985, they were
the first to envision making such a genetically humanized mouse,
and Regeneron has spent decades inventing and developing
VelocImmune and related VelociSuite technologies. Dr.
Yancopoulos and his team have used VelocImmune technology to
create approximately a quarter of all original, FDA-approved fully
human monoclonal antibodies currently available. This includes
REGEN-COV (casirivimab and imdevimab), Dupixent®
(dupilumab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab,
maftivimab and odesivimab-ebgn).
U.S. AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION
Treatment:
REGEN-COV is authorized for the treatment
of mild to moderate coronavirus disease 2019 (COVID-19) in adults
and pediatric patients (12 years of age and older weighing at least
40 kg) with positive results of direct SARS-CoV-2 viral testing,
and who are at high risk for progression to severe COVID-19,
including hospitalization or death
Limitations of Authorized Use (Treatment)
- REGEN-COV is not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to
COVID-19 in those on chronic oxygen therapy due to underlying
non-COVID-19 related comorbidity
- Monoclonal antibodies, such as REGEN-COV, may be associated
with worse clinical outcomes when administered to hospitalized
patients with COVID-19 requiring high-flow oxygen or mechanical
ventilation
Post-Exposure Prophylaxis:
REGEN-COV is authorized in adult and pediatric individuals (12
years of age and older weighing at least 40 kg) for post-exposure
prophylaxis of COVID-19 in individuals who are at high risk for
progression to severe COVID-19, including hospitalization or death,
and are:
- not fully vaccinated or who are not expected to
mount an adequate immune response to complete SARS-CoV-2
vaccination (for example, individuals with immunocompromising
conditions including those taking immunosuppressive medications)
and
- have been exposed to an individual infected with SARS-CoV-2
consistent with close contact criteria per Centers for Disease
Control and Prevention (CDC) or
- who are at high risk of exposure to an individual infected with
SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other
individuals in the same institutional setting (for example, nursing
homes, prisons)
Limitations of Authorized Use (Post-Exposure
Prophylaxis)
- Post-exposure prophylaxis with REGEN-COV is not a substitute
for vaccination against COVID-19
- REGEN-COV is not authorized for pre-exposure prophylaxis for
prevention of COVID-19
REGEN-COV has not been approved, but has been authorized for
emergency use by FDA
These uses are authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use under section 564(b)(1) of the Act,
21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner
Healthcare providers should review the Fact Sheet for
Healthcare Providers for information on the authorized
uses of REGEN-COV and mandatory requirements of the EUA and must
comply with the requirements of the EUA. The FDA Letter of
Authorization is available for reference, as well
as the Dear Healthcare Provider Letter and Patient
Fact Sheet
Criteria for Identifying High Risk Individuals
Please refer to the Fact Sheet for Healthcare Providers for
criteria for identifying high risk individuals
SARS-CoV-2 Viral Variants
Circulating SARS-CoV-2 viral variants may be associated with
resistance to monoclonal antibodies. Healthcare providers should
review the Antiviral Resistance information in Section 15 of the
Fact Sheet for details regarding specific variants and resistance,
and refer to the CDC website
(https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html)
as well as information from state and local health authorities
regarding reports of viral variants of importance in their region
to guide treatment decisions
Important Safety Information
REGEN-COV (casirivimab and imdevimab) is an unapproved
investigational therapy, and there are limited clinical data
available. Serious and unexpected adverse events may occur that
have not been previously reported with REGEN-COV use
- Contraindication:
REGEN-COV is contraindicated in
individuals with previous severe hypersensitivity reactions,
including anaphylaxis, to REGEN-COV
- Warnings and Precautions:
- Hypersensitivity Including
Anaphylaxis and Infusion-Related Reactions: Serious
hypersensitivity reactions, including anaphylaxis, have been
observed with administration of REGEN-COV. If signs or symptoms of
a clinically significant hypersensitivity reaction or anaphylaxis
occur, immediately discontinue administration and initiate
appropriate medications and/or supportive therapy. Hypersensitivity
reactions occurring more than 24 hours after the infusion have also
been reported with the use of REGEN-COV under EUA. Infusion-related
reactions, occurring during the infusion and up to 24 hours after
the infusion, have been observed with administration of REGEN-COV.
These reactions may be severe or life threatening
- Signs and symptoms of
infusion-related reactions may include: fever, difficulty
breathing, reduced oxygen saturation, chills, nausea, arrhythmia
(e.g., atrial fibrillation, tachycardia, bradycardia), chest pain
or discomfort, weakness, altered mental status, headache,
bronchospasm, hypotension, hypertension, angioedema, throat
irritation, rash including urticaria, pruritus, myalgia, vasovagal
reactions (e.g., pre-syncope, syncope), dizziness, fatigue and
diaphoresis. Consider slowing or stopping the infusion and
administer appropriate medications and/or supportive care if an
infusion-related reaction occurs
- Clinical Worsening After
REGEN-COV Administration: Clinical worsening of COVID-19
after administration of REGEN-COV has been reported and may include
signs or symptoms of fever, hypoxia or increased respiratory
difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia,
bradycardia), fatigue, and altered mental status. Some of these
events required hospitalization. It is not known if these events
were related to REGEN-COV use or were due to progression of
COVID-19
- Limitations of Benefit and
Potential for Risk in Patients with Severe
COVID-19: Monoclonal antibodies, such as REGEN-COV, may be
associated with worse clinical outcomes when administered to
hospitalized patients with COVID-19 requiring high-flow oxygen or
mechanical ventilation. Therefore, REGEN-COV is not authorized for
use in patients who are hospitalized due to COVID-19, OR who
require oxygen therapy due to COVID-19, OR who require an increase
in baseline oxygen flow rate due to COVID-19 in those on chronic
oxygen therapy due to underlying non-COVID-19–related
comorbidity
- Adverse Reactions:
- COV-2067 (Treatment):
Infusion-related reactions (adverse event assessed as causally
related by the investigator) of grade 2 or higher severity have
been observed in 10/4,206 (0.2%) of those who received REGEN-COV at
the authorized dose or a higher dose. Three subjects receiving the
8,000 mg dose of REGEN-COV, and one subject receiving the 1,200 mg
casirivimab and 1,200 mg imdevimab, had infusion-related reactions
(urticaria, pruritus, flushing, pyrexia, shortness of breath, chest
tightness, nausea, vomiting, rash) which resulted in permanent
discontinuation of the infusion. All events resolved. Anaphylactic
reactions have been reported in the clinical program in subjects
receiving REGEN-COV. The events began within 1 hour of completion
of the infusion, and in at least one case required treatment
including epinephrine. The events resolved
- COV-2069 (Post-exposure
prophylaxis): In subjects who were SARS-CoV-2 negative at
baseline (Cohort A), injection site reactions (all grade 1 and 2)
occurred in 55 subjects (4%) in the REGEN-COV group and 19 subjects
(2%) in the placebo group. The most common signs and symptoms of
injection site reactions which occurred in at least 1% of subjects
in the REGEN-COV group were erythema and pruritus.
Hypersensitivity reactions occurred in 2 subjects (0.2%) in the
REGEN-COV group and all hypersensitivity reactions were grade 1 in
severity. In subjects who were SARS-CoV-2 positive at baseline
(Cohort B), injection site reactions, all of which were grade 1 or
2, occurred in 6 subjects (4%) in the REGEN-COV group and 1 subject
(1%) in the placebo group. The most common signs and symptoms of
injection site reactions which occurred in at least 1% of subjects
in the REGEN-COV group were ecchymosis and erythema
- COV-2093 (Subcutaneous
Dosing): Injection site reactions occurred in 12% and 4%
of subjects following single dose administration in the REGEN-COV
and placebo groups, respectively. Remaining safety finding
following subcutaneous administration in the REGEN-COV group were
similar to the safety findings observed with intravenous
administration in COV-2067. With repeat dosing, injection site
reactions occurred in 252 subjects (35%) in the REGEN-COV group and
38 subjects (16%) in the placebo group; all injection site
reactions were grade 1 or 2 in severity. Hypersensitivity reactions
occurred in 8 subjects (1%) in the REGEN-COV group; and all
hypersensitivity reactions were grade 1 or 2 in severity. There
were no cases of anaphylaxis
- Patient Monitoring Recommendations: Clinically
monitor patients during dose administration and observe patients
for at least 1 hour after intravenous infusion or subcutaneous
dosing is complete
- Use in Specific Populations:
- Pregnancy: There are
insufficient data to evaluate a drug-associated risk of major birth
defects, miscarriage, or adverse maternal or fetal outcomes.
REGEN-COV should only be used during pregnancy if the potential
benefit outweighs the potential risk for the mother and the
fetus
- Lactation: There are no available data on the
presence of casirivimab and/or imdevimab in human milk or animal
milk, the effects on the breastfed infant, or the effects of the
drug on milk production. The development and health benefits of
breastfeeding should be considered along with the mother's clinical
need for REGEN-COV and any potential adverse effects on the
breastfed child from REGEN-COV or from the underlying maternal
condition
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-looking Statements and Use of Digital
Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such as
"anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying words.
These statements concern, and these risks and uncertainties
include, among others, the impact of SARS-CoV-2 (the virus that has
caused the COVID-19 pandemic) on Regeneron's business and its
employees, collaborators, and suppliers and other third parties on
which Regeneron relies, Regeneron's and its collaborators' ability
to continue to conduct research and clinical programs, Regeneron's
ability to manage its supply chain, net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and product
candidates being developed by Regeneron and/or its collaborators
(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
limitation the development program relating to the
REGEN-COVTM (casirivimab and imdevimab) antibody
cocktail; how long the Emergency Use Authorization ("EUA") granted
by the U.S. Food and Drug Administration (the "FDA") for REGEN-COV
will remain in effect and whether the EUA is revoked by the FDA
based on its determination that the underlying health emergency no
longer exists or warrants such authorization or other reasons; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's Product Candidates (such as
REGEN-COV, including the possible FDA approval based on the
Biologics License Applications referenced in this press release)
and new indications for Regeneron's Products; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron's Products and Regeneron's Product Candidates,
including the impact of recommendations, guidelines, or
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on any of the foregoing or any potential
regulatory approval of Regeneron's Products and Regeneron's
Product Candidates (such as
REGEN-COV); the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
product candidates (including REGEN-COV) and the impact of the
foregoing on Regeneron's ability to supply its Products and product
candidates, including its ability to supply doses of REGEN-COV
under the terms of the agreement with the U.S. Department of Health
and Human Services and the Department of Defense (collectively, the
"U.S. Government") discussed in this press release (the
"Manufacturing and Supply Agreement"); whether and to what extent
Regeneron will be able to supply doses of REGEN-COV under the
Manufacturing and Supply Agreement; the amount and timing of
payments (if any) Regeneron may receive pursuant to the
Manufacturing and Supply Agreement; whether the Manufacturing and
Supply Agreement is terminated by the U.S. Government or otherwise
prior to completion; the ability of Regeneron to manage supply
chains for multiple products and product candidates; safety issues
resulting from the administration of Regeneron's Products and
Regeneron's Product Candidates (such as REGEN-COV) in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and Regeneron's Product Candidates
in clinical trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and Regeneron's Product Candidates, including without
limitation REGEN-COV; ongoing regulatory obligations and oversight
impacting Regeneron's Products, research and clinical programs, and
business, including those relating to patient privacy; the
availability and extent of reimbursement of Regeneron's Products
from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to, or
more cost effective than, Regeneron's Products and Regeneron's
Product Candidates; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
collaborators may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
guidance; the potential for any license, collaboration, or supply
agreement, including Regeneron's agreements with Sanofi, Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), as well as Regeneron's collaboration
with Roche relating to the casirivimab and imdevimab antibody
cocktail (known as REGEN-COV in the
United States and Ronapreve™ in other countries), to be
cancelled or terminated; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto (including without limitation the patent litigation and
other related proceedings relating to EYLEA®
(aflibercept) Injection, Dupixent® (dupilumab),
Praluent® (alirocumab), and REGEN-COV), other litigation
and other proceedings and government investigations relating to the
Company and/or its operations, the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing
may have on Regeneron's business, prospects, operating results, and
financial condition. A more complete description of these and other
material risks can be found in Regeneron's filings with the U.S.
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2020 and its
Form 10-Q for the quarterly period ended June 30, 2021. Any forward-looking statements are
made based on management's current beliefs and judgment, and the
reader is cautioned not to rely on any forward-looking statements
made by Regeneron. Regeneron does not undertake any obligation to
update (publicly or otherwise) any forward-looking statement,
including without limitation any financial projection or guidance,
whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Contacts:
Media
Relations
Sarah
Cornhill
media@regeneron.com
|
Investor
Relations
Mark
Hudson
investor@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.