TARRYTOWN, N.Y., Oct. 30, 2020 /PRNewswire/ --
The IDMC also recommends continuation of
enrollment in the REGN-COV2 outpatient trial
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) received today a
recommendation from the independent data monitoring committee
(IDMC) for the REGN-COV2 antibody cocktail treatment trials for
COVID-19 that the current hospitalized patient trial be modified.
Specifically, based on a potential safety signal and an unfavorable
risk/benefit profile at this time, the IDMC recommends further
enrollment of patients requiring high-flow oxygen or mechanical
ventilation be placed on hold pending collection and analysis of
further data on patients already enrolled. The IDMC also
recommends continuing enrollment of hospitalized patients requiring
either no or low-flow oxygen as the risk/benefit remains acceptable
in these cohorts. Finally, the IDMC recommends continuation of the
outpatient trial without modification.
Regeneron remains blinded to the data and is implementing the
IDMC recommendations. Regeneron is also informing the U.S. Food and
Drug Administration, which is currently evaluating REGN-COV2 for a
potential Emergency Use Authorization in mild-to-moderate
outpatients at high risk for poor outcomes. Regeneron is also
sharing the recommendation with the independent committee
monitoring the RECOVERY trial in the UK, which is evaluating
REGN-COV2 in hospitalized patients.
About the REGN-COV2 Trial in Hospitalized Patients
The trial is designed to enroll patients in four independently
randomized cohorts:
- Cohort 1: patients on low-flow oxygen
- Cohort 1A: patients not requiring oxygen
- Cohort 2: patients on high-flow oxygen
- Cohort 3: patients on mechanical ventilation
About REGN-COV2
REGN-COV2 is a combination of two
monoclonal antibodies (REGN10933 and REGN10987) and was designed
specifically to block infectivity of SARS-CoV-2, the virus that
causes COVID-19.
To develop REGN-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 REGN-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.
REGN-COV2's development and manufacturing has been funded in
part with federal funds 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 under OT number: HHSO100201700020C.
Regeneron has partnered with Roche to increase the global
supply of REGN-COV2 beginning in 2021. If REGN-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.
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 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 REGN-COV2 (Regeneron's investigational dual antibody
for the treatment and prevention of COVID-19); safety issues
resulting from the administration of Regeneron's Products and
product candidates (such as REGN-COV2) in patients, including
serious complications or side effects in connection with the use of
Regeneron's Products and product candidates in clinical trials; the
impact of the recommendation of the independent data monitoring
committee for the REGN-COV2 trials and the potential safety signal
discussed in this press release on further clinical development of
REGN-COV2, the decision by the U.S. Food and Drug Administration
("FDA") with respect to a potential Emergency Use Authorization
("EUA") for REGN-COV2, and possible regulatory approval of
REGN-COV2; whether the FDA will grant an EUA for REGN-COV2 and, if
an EUA is granted, the scope and terms of such EUA and how long
such EUA would remain in effect for REGN-COV2; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's product candidates (such as REGN-COV2) and
new indications for Regeneron's Products; the ability of Regeneron
to manufacture in anticipated quantities Regeneron's Products and
product candidates, including REGN-COV2; the ability of Regeneron
to manufacture and 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 studies evaluating
REGN-COV2 discussed in this press release, on any potential
regulatory approval (including with respect to REGN-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
REGN-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 or collaboration 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 REGN-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 June 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.