TARRYTOWN, N.Y., Jan. 27, 2021 /PRNewswire/ --
Columbia University researchers
and Regeneron have independently confirmed findings; data included
in bioRxiv paper and submitted for peer-reviewed
publication
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that researchers in Dr. David Ho's
Columbia University lab and Regeneron
scientists have independently confirmed that REGEN-COVTM
(casirivimab and imdevimab antibody cocktail) successfully
neutralizes the circulating SARS-CoV-2 variants first identified in
the UK (B.1.1.7) and South Africa
(B.1.351). Columbia's findings were included in a paper posted to
bioRxiv and submitted for peer-reviewed publication on the changing
resistance of SARS-CoV-2 variants to antibody neutralization.
Both teams of researchers assessed in vitro
neutralization potency of numerous COVID-19 antibodies (including
those that have received emergency authorization and those still in
development) against various mutated strains of the virus. Although
some antibody therapies were no longer effective against some of
these variants, the REGEN-COV antibody cocktail continued to
neutralize all variants tested. REGEN-COV, which consists of the
highly potent neutralizing antibodies imdevimab (REGN10987) and
casirivimab (REGN10933), retained its potent neutralizing
capability against the B.1.1.7 variant, with both antibodies
retaining their potency. REGEN-COV also retained its highly potent
neutralizing capacity against the B.1.351 variant; imdevimab
retained its potency against this variant, and, while casirivimab
potency was reduced, it was still comparable to the potency that
other single antibodies in development have against the original
virus.
The variant first identified in Brazil (1.1.248) and recently seen in a
patient in the United States
contains the same receptor binding domain mutations as the B.1.351
variant, therefore REGEN-COV is expected to remain similarly
potent. Regeneron is conducting additional preclinical research
against this particular strain to confirm this.
"As we expected, the virus continues to mutate, and these data
show the continued ability of REGEN-COV to neutralize emerging
strains, further validating our multi-antibody cocktail approach to
infectious diseases," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "With two complimentary antibodies in one
therapeutic, even if one has reduced potency, the risk of the
cocktail losing efficacy is significantly diminished, since the
virus would need to mutate in multiple distinct locations to evade
both antibodies. Thanks to our proprietary
VelocImmune® technology, we have hundreds of
additional potent, neutralizing antibodies in our labs that could
form new combinations that might be useful against future variants.
We are evaluating potential next steps with these novel
candidates."
"In the face of this daunting pandemic, we appreciate the open
exchange of pre-publication data and the opportunity to confirm
important findings with one of the world's leading academic
laboratories," said Christos A.
Kyratsous, Ph.D., Vice President of Research, Infectious
Diseases and Viral Vector Technologies at Regeneron.
The development and manufacturing of REGEN-COV has been funded
in part with federal funds from the Biomedical Advanced
Research and Development Authority (BARDA), part of the U.S.
Department of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response, under OT
number: HHSO100201700020C.
About the REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab and imdevimab) is a cocktail of two monoclonal
antibodies (also known as REGN10933 and REGN10987) and was designed
specifically to block infectivity of SARS-CoV-2, the virus that
causes COVID-19. 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 Science.
In November 2020, REGEN-COV
received Emergency Use Authorization (EUA) from the FDA for the
treatment of mild to moderate COVID-19 in adults, as well as in
pediatric patients at least 12 years of age and weighing at least
40 kg, who have received positive results of direct SARS-CoV-2
viral testing and are at high risk for progressing to severe
COVID-19 and/or hospitalization. The clinical evidence from
Regeneron's outpatient trial suggests that monoclonal antibodies
such as casirivimab and imdevimab have the greatest benefit when
given early after diagnosis and in patients who are seronegative
and/or who have high viral load. The criteria for 'high-risk'
patients are described in the Fact Sheet for Healthcare Providers.
In the U.S., casirivimab and imdevimab are not authorized 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.
Regeneron is collaborating with Roche to increase global
supply of REGEN-COV. Regeneron is responsible for development and
distribution of the treatment in the U.S., and Roche is primarily
responsible for development and distribution outside the U.S. The
companies 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.
AUTHORIZED USE AND IMPORTANT SAFETY
INFORMATION
Authorized Emergency Use
Casirivimab
and imdevimab injection is an investigational combination therapy
and has been authorized by FDA for the emergency use described
above. Casirivimab and imdevimab injection is not FDA approved for
any use. Safety and effectiveness of casirivimab and imdevimab
injection have not yet been established for the treatment of
COVID-19.
This authorized use is 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.
Limitations of Authorized Use
- Casirivimab and imdevimab injection 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.
- Benefit of treatment with casirivimab and imdevimab injection
has not been observed in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as casirivimab and imdevimab, may be
associated with worse clinical outcomes when administered to
hospitalized patients requiring high flow oxygen or mechanical
ventilation with COVID-19.
Definition of High-Risk Patients
High-risk is defined as patients who meet at least one of the
following criteria:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- Are ≥55 years of age AND have
-
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory
disease.
- Are 12 – 17 years of age AND have
-
- BMI ≥85th percentile for their age and gender based on CDC
growth charts, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, cerebral palsy,
OR
- a medical-related technological dependence, for example,
tracheostomy, gastrostomy, or positive pressure ventilation (not
related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease
that requires daily medication for control.
Warnings and Precautions:
- Hypersensitivity Including Anaphylaxis and Infusion-Related
Reactions: There is a potential for serious hypersensitivity
reaction, including anaphylaxis, with administration of casirivimab
and imdevimab injection. If signs or symptoms of a clinically
significant hypersensitivity reaction or anaphylaxis occur,
immediately discontinue administration and initiate appropriate
medications and/or supportive therapy. Infusion-related reactions
have been observed with administration of casirivimab and imdevimab
injection. Signs and symptoms of infusion related reactions may
include fever, chills, nausea, headache, bronchospasm, hypotension,
angioedema, throat irritation, rash including urticaria, pruritus,
myalgia, and/or dizziness. If an infusion-related reaction occurs,
consider slowing or stopping the infusion and administer
appropriate medications and/or supportive care.
- Limitations of Benefit and Potential for Risk in Patients
with Severe COVID-19: Benefit of treatment with casirivimab and
imdevimab injection has not been observed in patients hospitalized
due to COVID-19. Monoclonal antibodies, such as casirivimab and
imdevimab, may be associated with worse clinical outcomes when
administered to hospitalized patients requiring high flow oxygen or
mechanical ventilation with COVID-19. Therefore, casirivimab and
imdevimab injection is not authorized for use in 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:
- Serious adverse events (SAEs) were reported in 4 (1.6%)
patients in the casirivimab and imdevimab injection 2,400 mg group,
2 (0.8%) patients in casirivimab and imdevimab injection 8,000 mg
group and 6 (2.3%) patients in the placebo group. None of the SAEs
were considered to be related to study drug. SAEs that were
reported as Grade 3 or 4 adverse events were pneumonia,
hyperglycemia, nausea and vomiting (2,400 mg casirivimab and
imdevimab injection), intestinal obstruction and dyspnea (8,000 mg
casirivimab and imdevimab injection) and COVID-19, pneumonia and
hypoxia (placebo). Casirivimab and imdevimab injection are not
authorized at the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg
imdevimab).
Patient Monitoring Recommendations: Clinically monitor
patients during infusion and observe patients for at least 1 hour
after infusion is complete.
Use in Specific Populations:
- Pregnancy: There is currently limited clinical
experience in the use of casirivimab and imdevimab injection in
COVID-19 patients who are pregnant. Casirivimab and imdevimab
injection therapy should be used during pregnancy only if the
potential benefit justifies the potential risk for the mother and
the fetus.
- Nursing Mothers: There is currently no clinical
experience in use of casirivimab and imdevimab injection in
COVID-19 patients who are breastfeeding. The development and health
benefits of breastfeeding should be considered along with the
mother's clinical need for casirivimab and imdevimab injection and
any potential adverse effects on the breastfed child from
casirivimab and imdevimab injection 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 eight
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, 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 and research and clinical programs
now underway or planned, including without limitation the
development program relating to 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) and new
indications for Regeneron's Products; 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 REGEN-COV); 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 product candidates (such as REGEN-COV) in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and product candidates in clinical
trials; uncertainty of market acceptance and commercial success of
Regeneron's Products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on any potential regulatory approval
(including with respect to REGEN-COV) and/or the commercial success
of Regeneron's Products and product candidates; 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 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 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 REGEN-COV,
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), and Praluent® (alirocumab)), 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, 2019 and its Form 10-Q for the
quarterly period ended September 30,
2020. 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
Alexandra
Bowie
Tel: +1 (914) 847-3407
Alexandra.bowie@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.