Regeneron's REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA
                         Emergency Use Authorization

PR Newswire

TARRYTOWN, N.Y., Nov. 21, 2020

TARRYTOWN, N.Y., Nov. 21, 2020 /PRNewswire/ --

First treatment of any kind to have prospectively confirmed and statistically
significant anti-viral activity against SARS-CoV-2

Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk

Initial doses of REGEN-COV2 will be made available to approximately 300,000
patients, with no medication out-of-pocket costs, under U.S. government
allocation program

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the
antibody cocktail casirivimab and imdevimab administered together (also known
as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in
COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Food
and Drug Administration (FDA). Casirivimab and imdevimab administered together
are authorized 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 REGEN-COV2 have the greatest
benefit when given early after diagnosis and in patients who have not yet
mounted their own immune response or who have high viral load.

The criteria for 'high-risk' patients are described in the Fact Sheet for
Health Care Providers. Casirivimab and imdevimab are not authorized for use in
patients who are hospitalized or require oxygen therapy due to COVID-19, or
for people currently using chronic oxygen therapy because of an underlying
comorbidity who require an increase in baseline oxygen flow rate due to

"This FDA Emergency Use Authorization is an important step in the fight
against COVID-19, as high-risk patients in the United States will have access
to a promising therapy early in the course of their infection," said Leonard
S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.
"The science and technology investments Regeneron has made over three decades
positioned us to move rapidly to invent, study and maximize production of
REGEN-COV2. Even with these incredible efforts, demand may exceed supply
initially, making it even more critical that federal and state governments
ensure REGEN-COV2 is distributed fairly and equitably to the patients most in
need. In the first quarter of 2021, we expect to increase available REGEN-COV2
global supply as we continue our collaboration with Roche."

"REGEN-COV2 is designed to mimic what a well-functioning immune system does by
using very potent antibodies to neutralize the virus," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
"Data from approximately 800 non-hospitalized patients showed significant
reductions in virus levels within days of receiving REGEN-COV2, which were
associated with significantly fewer medical visits. This benefit was greatest
in patients most at risk for poor outcomes due to high viral load, ineffective
immune response at baseline or pre-existing risk factors. We are encouraged
that no variants resistant to the cocktail were identified in the clinical
trial analyses to date, which is consistent with our preclinical findings. We
are also very encouraged by recently announced promising vaccine results;
however, there remains a need to treat patients who develop COVID-19,
especially as some may not have had access to or were not protected by
vaccination. Importantly, we continue to advance our rigorous clinical trial
program evaluating the safety and efficacy of REGEN-COV2 for both the
treatment and prevention of COVID-19, and we will share new results as

Production of monoclonal antibodies is a complex, time- and labor-intensive
process that requires deep expertise. Utilizing production and manufacturing
platforms developed over decades, Regeneron rapidly scaled up REGEN-COV2,
beginning in the early days of the pandemic with support from the Biomedical
Advanced Research and Development Authority (BARDA), part of the Office of the
Assistant Secretary for Preparedness and Response at the U.S. Department of
Health and Human Services. Regeneron now expects to have REGEN-COV2 treatment
doses ready for approximately 80,000 patients by the end of November,
approximately 200,000 patients by the first week of January, and approximately
300,000 patients in total by the end of January 2021.

As part of Operation Warp Speed, in July the U.S. government and Regeneron
signed an agreement for this initial supply of REGEN-COV2. The U.S. government
will coordinate with state authorities to allocate REGEN-COV2 on a weekly
basis based on the number of COVID-19 cases in each state. The government has
committed to providing these 300,000 doses at no cost to patients, although
healthcare facilities may charge fees related to administration. Regeneron
will immediately begin shipping REGEN-COV2 to Amerisource Bergen, a national
distributor, which will distribute the therapy as directed by the government.

Under the EUA, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of
imdevimab (2,400 mg total) administered as a single intravenous infusion. The
authorization is based on positive Phase 2 data announced in September and
October from the first 799 adults in an ongoing randomized, double-blind,
placebo-controlled trial of non-hospitalized patients ("outpatients") with

The FDA grants Emergency Use Authorization to medicines that may help
diagnose, treat or prevent a life-threatening disease when adequate and
approved alternatives are not available. The EUA is temporary and does not
take the place of a formal biologics license application (BLA) submission
review and approval process. This use is authorized only for the duration of
the declaration that circumstances exist justifying the authorization of the
emergency use, unless terminated or revoked sooner. Casirivimab and imdevimab
have not been approved by FDA and remain investigational. Evaluation of its
safety and efficacy is ongoing in multiple clinical trials. Data from these
trials will be used to support a future BLA submission. Health care providers
should review the Fact Sheet for detailed information on the authorized use
and requirements of the EUA and may call 844-734-6643 for more information.
Please see the Fact Sheet and FDA Letter of Authorization at

REGEN-COV2 continues to be evaluated in Phase 2/3 clinical trials for the
treatment of COVID-19 in certain hospitalized and non-hospitalized patients,
the Phase 3 open-label RECOVERY trial of hospitalized patients in the UK, and
a Phase 3 trial for the prevention of COVID-19 in household contacts of
infected individuals. To date, more than 7,000 people have participated in
REGEN-COV2 clinical trials.

REGEN-COV2 is a cocktail of two monoclonal antibodies (casirivimab and
imdevimab, 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 REGEN-COV2, 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 REGEN-COV2 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.

REGEN-COV2's development and manufacturing has been funded in part with
federal funds from BARDA under OT number: HHSO100201700020C. Regeneron
continues to increase in-house production of REGEN-COV2, and the company has
partnered with Roche to increase the global supply of REGEN-COV2 beginning in
2021. If REGEN-COV2 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 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 Emergency Use

Casirivimab and imdevimab injection (REGEN-COV2) 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

  o Casirivimab and imdevimab injection is not authorized for use in patients:

       o who are hospitalized due to COVID-19, OR
       o who require oxygen therapy due to COVID-19, OR
       o 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.

  o 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

  o Have a body mass index (BMI) ≥35
  o Have chronic kidney disease
  o Have diabetes
  o Have immunosuppressive disease
  o Are currently receiving immunosuppressive treatment
  o Are ≥65 years of age
  o Are ≥55 years of age AND have

       o cardiovascular disease, OR
       o hypertension, OR
       o chronic obstructive pulmonary disease/other chronic respiratory

  o Are 12 – 17 years of age AND have

       o BMI ≥85th percentile for their age and gender based on CDC growth
         charts, OR
       o sickle cell disease, OR
       o congenital or acquired heart disease, OR
       o neurodevelopmental disorders, for example, cerebral palsy, OR
       o a medical-related technological dependence, for example,
         tracheostomy, gastrostomy, or positive pressure ventilation (not
         related to COVID-19)
       o asthma, reactive airway or other chronic respiratory disease that
         requires daily medication for control.

Warnings and Precautions: 

  o 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.
  o 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:

  o 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: 

  o 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.
  o 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

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 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 REGEN-COV2 (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 REGEN-COV2 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-COV2) and new indications for
Regeneron's Products; safety issues resulting from the administration of
Regeneron's Products and product candidates (such as REGEN-COV2) 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 REGEN-COV2; 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 REGEN-COV2) 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-COV2;
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-COV2, 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
( and its Twitter feed


Media Relations
Alexandra Bowie
Tel: +1 (914) 847-3407

Investor Relations
Mark Hudson
Tel: +1 (914) 847-3482 

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SOURCE Regeneron Pharmaceuticals, Inc.


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