TARRYTOWN, N.Y., Dec. 17, 2020 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the New England Journal of Medicine (NEJM) has published
initial clinical data from an ongoing seamless Phase 1/2/3 trial of
the antibody cocktail casirivimab and imdevimab in non-hospitalized
patients with COVID-19.
"The peer-reviewed NEJM publication of our first set of
clinical data in recently infected COVID-19 patients showed that
casirivimab and imdevimab effectively reduced viral load and the
need for medically-attended visits, with the greatest benefit in
patients who had not yet mounted their own effective immune
response or had high viral load at baseline," said David Weinreich, M.D., Senior Vice President and
Head of Global Clinical Development at Regeneron and lead author of
the publication. "The investigational cocktail is now available to
indicated high-risk U.S. patients under an Emergency Use
Authorization, and we also continue a robust clinical
development program."
"Building on these initial findings, we were gratified to
recently report follow-on data from the next-stage analysis of this
ongoing trial, which prospectively replicated these results in a
rigorous and statistically significant manner. These follow-on data
provided the first definitive prospective evidence demonstrating
anti-viral activity for a treatment regimen now available for
COVID-19, and also further documented the ability of this treatment
to decrease the need for further medical attention," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "We are
continuing to evaluate our antibody cocktail in this outpatient
setting, as well as in late-stage trials in hospitalized
patients and for prevention of infection, and will continue to
share our findings as quickly as possible."
Regeneron previously announced the initial results featured in
this NEJM publication from the Phase 1/2 portion of the
trial that enrolled 275 patients randomized 1:1:1 to receive 8
grams casirivimab and imdevimab (high-dose, n=90), 2.4 grams
casirivimab and imdevimab (low-dose, n=92) or placebo (n=93).
Approximately 56% of patients were Latino/Hispanic, 13% were
Black/African American and 64% had one or more underlying risk
factors for severe COVID-19, including obesity (more than 40%).
Regeneron also subsequently announced additional prospective
results in a total of 799 patients from the trial. In both the
initial descriptive analyses of 275 patients, as well as in the
following prospective analyses involving a total of 799 patients, a
greater effect was observed in patients treated with the antibody
cocktail who did not have SARS-CoV-2 antibodies at baseline
('sero-antibody-negative') or who had high viral load at baseline.
As would be expected, a much higher proportion of
sero-antibody-negative patients had high viral loads when they
entered the trial. Additionally, a smaller proportion of antibody
cocktail-treated patients required medically-attended visits due to
COVID-19 (inclusive of hospitalizations, urgent care or emergency
room visits, in-person physician or telemedicine visits) through
day 29 compared to placebo; there was an even greater benefit on
this endpoint among sero-antibody-negative patients.
In the initial 275 patients, rates of adverse events (AEs) were
similar among groups. Serious AEs occurred in 2 placebo patients, 1
low-dose patient and 0 high-dose patients. AEs included
infusion-related reactions (1 placebo patient, 0 low-dose patients,
2 high-dose patients) and hypersensitivity reactions (2 placebo
patients, 0 low-dose patients, 1 high-dose patient).
About casirivimab and imdevimab
Casirivimab and
imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail
of two monoclonal antibodies (also known as REGN10933 and
REGN10987, respectively) and was designed specifically to block
infectivity of SARS-CoV-2, the virus that causes COVID-19.
To develop this novel medicine, Regeneron scientists evaluated
thousands of fully-human antibodies produced by the
company's VelocImmune® mice, which have
been genetically modified to have a human immune system, as well as
antibodies identified from humans who have recovered from 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.
The development and manufacturing of the antibody cocktail has
been funded in part with federal funds from BARDA under OT number:
HHSO100201700020C. Data from the Phase 1/2/3 clinical trial
supported an Emergency Use Authorization for casirivimab and
imdevimab administered together, granted by the U.S. Food and Drug
Administration (FDA) for the treatment of mild to moderate COVID-19
in patients 12 years of age and older 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. Regeneron continues to increase in-house
production of casirivimab and imdevimab, and the company
has partnered with Roche to increase the global supply
beginning in 2021. If the therapy proves safe and effective in
clinical trials and regulatory approvals are granted, Regeneron
will manufacture and distribute it in the U.S., and Roche will
develop, manufacture and distribute it outside of the U.S. Once
both companies are at full manufacturing capacity in 2021, there
are expected to be at least 2 million treatment doses available
annually.
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).
Casirivimab and imdevimab are not authorized at the 8,000 mg
dose (4,000 mg casirivimab and 4,000 mg imdevimab).
- One anaphylactic reaction was reported in the clinical program.
The event began within 1 hour of completion of the infusion, and
required treatment including epinephrine. The event resolved.
Infusion-related reactions, of grade 2 or higher severity, were
reported in 4 subjects (1.5%) in the 8,000 mg (4,000 mg casirivimab
and 4,000 mg imdevimab) arm. These infusion-related reactions
events were moderate in severity; and include pyrexia, chills,
urticaria, pruritus, abdominal pain, and flushing. One
infusion-related reaction (nausea) was reported in the placebo arm
and none were reported in the 2,400 mg (1,200 mg casirivimab and
1,200 mg imdevimab) arm. In two subjects receiving the 8,000 mg
dose of casirivimab and imdevimab, the infusion-related reactions
(urticaria, pruritus, flushing, pyrexia, shortness of breath, chest
tightness, nausea, vomiting) resulted in permanent discontinuation
of the infusion. All events resolved.
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, 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.
Regeneron 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 (including
those discussed in this press release), 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 casirivimab and imdevimab (Regeneron's investigational
multi-antibody therapy for the treatment and prevention of
COVID-19); how long the Emergency Use Authorization ("EUA") granted
by the U.S. Food and Drug Administration (the "FDA")
for casirivimab and imdevimab 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 casirivimab and
imdevimab) and new indications for Regeneron's Products; safety
issues resulting from the administration of Regeneron's Products
and product candidates (such as casirivimab and imdevimab) in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and product
candidates in clinical trials (including those discussed in this
press release); the ability of Regeneron to manufacture in
anticipated quantities Regeneron's Products and product candidates,
including casirivimab and imdevimab; the ability of Regeneron
to manage supply chains for multiple products and product
candidates; 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;
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), including the trials discussed in this
press release, on any potential regulatory approval (including with
respect to casirivimab and imdevimab) 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 casirivimab
and imdevimab; 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 casirivimab and imdevimab, 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).
Regeneron
Contacts:
Media
Relations
Hannah
Kwagh
media@regeneron.com
|
Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
Mark.Hudson@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.