TARRYTOWN, N.Y., Jan. 12, 2021 /PRNewswire/ --
New agreement covers 1.25 million additional doses of the
casirivimab and imdevimab antibody cocktail, bringing total
potential U.S. supply to over 1.5 million doses
Doses are being supplied for use pursuant to the FDA
Emergency Use Authorization for high-risk patients with mild to
moderate COVID-19 in order to reduce the risk of progression to
severe COVID-19 and/or hospitalization
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 additional
supply of the casirivimab and imdevimab antibody cocktail for use
in non-hospitalized COVID-19 patients to meet the federal
government's Operation Warp Speed goals. The government has said it
will provide these doses at no cost to patients, though healthcare
facilities may charge fees related to administration.
Under the new agreement, the government will purchase all
finished doses of the casirivimab and imdevimab antibody cocktail
delivered by June 30, 2021, up to
1.25 million doses. Under a previous agreement, Regeneron is
already supplying doses to treat approximately 300,000 people,
bringing the total potential purchase to over 1.5 million
doses.
"COVID-19 continues to sicken hundreds of thousands of Americans
every day and the people of Regeneron are committed to help," said
Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer of Regeneron. "Tackling the
COVID-19 pandemic will require a combination of public health
measures, vaccines and therapeutics. We are pleased to work with
the U.S. government to supply our antibody cocktail as an important
weapon in this fight."
The U.S. government has said it will continue to coordinate
allocation of the antibody cocktail to state and territorial health
departments. Patients, caregivers and healthcare providers can find
sites with COVID-19 antibody treatments through these links to the
HHS or National Infusion Center Association locator
tools.
"Patients in our antibody cocktail outpatient clinical trial
experienced significant reductions in virus levels and required
fewer medical visits for COVID-19, suggesting the therapy can help
reduce the current burden on hospitals and healthcare systems,"
said George D. Yancopoulos, M.D.,
Ph.D., President and Chief Scientific Officer of Regeneron.
"Additionally, as expected, the virus continues to mutate, with the
possibility of developing resistance to any one antibody. The
Regeneron cocktail of two antibodies, each targeting a different
site on the virus, reduces the possibility of the virus becoming
resistant."
The casirivimab and imdevimab antibody cocktail continues to be
evaluated in clinical trials for the treatment of COVID-19 in
certain hospitalized and non-hospitalized patients, including the
open-label RECOVERY trial of hospitalized patients in the UK, and a
trial for the prevention of COVID-19 in household contacts of
infected individuals. To date, nearly 15,000 people have
participated in casirivimab and imdevimab clinical trials.
The development and manufacturing of the antibody cocktail has
been funded in part with federal funds from the Biomedical Advanced
Research and Development Authority (BARDA), part of HHS, Office of
the Assistant Secretary for Preparedness and Response, under OT
number: HHSO100201700020C.
Details of the New Agreement
The current authorized dose for emergency use in
non-hospitalized patients is 2,400 mg (1,200 mg casirivimab and
1,200 mg imdevimab) administered as a one-time infusion. Regeneron
is evaluating the safety and efficacy of a lower 1,200 mg dose (600
mg casirivimab and 600 mg imdevimab) of the antibody cocktail in
this 'outpatient' setting.
Under the agreement, the government will acquire doses at the
lowest authorized dose. The government is obligated to purchase all
finished doses supplied by June 30,
up to 1.25 million doses total (an agreement value of up
to $2.625 billion), and may accept doses after this date at
its discretion. A number of factors may impact available finished
supply by June 30, including
manufacturing considerations and authorized dose levels. Regeneron
expects to supply approximately 750,000 finished doses by the end
of June based on the 2,400 mg dose level, with the vast majority
supplied in the second quarter. Regeneron expects to fulfill the
entire 1.25 million targeted doses if the 1,200 mg dose is
authorized.
About the Regeneron Antibody Cocktail for COVID-19
Casirivimab and imdevimab 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. 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, the casirivimab
and imdevimab antibody combination 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 casirivimab and imdevimab. 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, 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 (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 the casirivimab
and imdevimab antibody cocktail (Regeneron's investigational
dual-antibody therapy for COVID-19); how long the Emergency Use
Authorization ("EUA") granted by the U.S. Food and Drug
Administration (the "FDA") for the casirivimab and imdevimab
antibody cocktail 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 the casirivimab and imdevimab antibody
cocktail) 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 the
casirivimab and imdevimab antibody cocktail) and the impact of the
foregoing on Regeneron's ability to supply its Products and product
candidates, including its ability to supply doses of the
casirivimab and imdevimab antibody cocktail 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 the casirivimab and imdevimab antibody cocktail
under the Manufacturing and Supply Agreement; what the lowest
authorized dose of the casirivimab and imdevimab antibody
cocktail will be at the time of delivery to the U.S. Government
under the Manufacturing and Supply Agreement; the amount 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
product candidates (such as the casirivimab and imdevimab
antibody cocktail) 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); 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 the casirivimab and imdevimab
antibody cocktail) 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 the casirivimab and imdevimab antibody cocktail;
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 the
casirivimab and imdevimab antibody cocktail, 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.