TARRYTOWN, N.Y., July 6, 2020 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the initiation
of late-stage clinical trials evaluating REGN-COV2, Regeneron's
investigational double antibody cocktail for the treatment and
prevention of COVID-19. A
Phase 3 trial will evaluate REGN-COV2's ability to prevent
infection among uninfected people who have had close exposure to a
COVID-19 patient (such as the patient's housemate), and is being
run jointly with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the
National Institutes of Health (NIH). REGN-COV2 has also moved
into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials
testing the cocktail's ability to treat hospitalized and
non-hospitalized (or "ambulatory") patients with COVID-19.
This clinical progress follows a positive review from the
Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety
results in an initial cohort of 30 hospitalized and
non-hospitalized patients with COVID-19.
The Phase 3 prevention trial is being
conducted at approximately 100 sites and is expected to enroll
2,000 patients in the U.S.; the trial will assess SARS-CoV-2
infection status. The two Phase 2/3 treatment trials in
hospitalized (estimated enrollment =1,850) and non-hospitalized
(estimated enrollment =1,050) patients are planned to be conducted
at approximately 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and
clinical endpoints, with preliminary data expected later this
summer. All trials are adaptively-designed, and the ultimate
numbers of patients enrolled will depend on trial progress and
insights from Phase 2 studies.
"We are running simultaneous adaptive trials in order to move as
quickly as possible to provide a potential solution to prevent and
treat COVID-19 infections, even in the midst of an ongoing global
pandemic," said George D. Yancopoulos, M.D., Ph.D.,
Co-Founder, President and Chief Scientific Officer of Regeneron.
"We are pleased to collaborate with NIAID to study REGN-COV2 in our
quest to further prevent the spread of the virus with an anti-viral
antibody cocktail that could be available much sooner than a
vaccine."
About REGN-COV2
Regeneron scientists evaluated
thousands of fully-human antibodies produced by the company's
proprietary VelocImmune® mice, which have been
genetically-modified to have a human immune system, as well as
antibodies isolated from humans who have recovered from COVID-19.
They selected the two most potent, non-competing and
virus-neutralizing antibodies to create REGN-COV2 and have scaled
up this dual-antibody cocktail for clinical use with the company's
in-house VelociMab® and manufacturing
capabilities. REGN-COV2's two antibodies 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 recent Science publications. More
recent research also demonstrates coverage against the now
prevalent D614G variant.
Regeneron used the same 'rapid response' capabilities and
cocktail approach to develop REGN-EB3, a novel triple antibody
treatment for Ebola that is now under regulatory review by the FDA.
REGN-COV2's development and manufacturing has been funded in part
with federal funds from the BARDA under OT number:
HHSO100201700020C.
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 seven
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, 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 REGN-COV2 (Regeneron's
investigational dual antibody cocktail for the prevention and
treatment of COVID-19) and REGN-EB3 (Regeneron's novel triple
antibody treatment for Ebola); the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's product candidates (such as REGN-COV2 and REGN-EB3) and
new indications for Regeneron's Products; unforeseen safety issues
resulting from the administration of Regeneron's Products and
product candidates (such as REGN-COV2 and REGN-EB3) in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and product candidates in clinical
trials; 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 and REGN-EB3; ongoing regulatory obligations and
oversight impacting Regeneron's Products, research and clinical
programs, and business, including those relating to patient
privacy; 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 the commercial success of Regeneron's
Products and product candidates; 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 Regeneron's Products and product
candidates; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in other studies and lead to therapeutic
applications; 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, labelling, distribution, and other steps
related to Regeneron's Products and product candidates;
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), to
be cancelled or terminated without any further product success; 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 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 March
31, 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 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
Vesna
Tosic
Tel: +1 (914) 847-5443
vesna.tosic@regeneron.com
View original
content:http://www.prnewswire.com/news-releases/regeneron-announces-start-of-regn-cov2-phase-3-covid-19-prevention-trial-in-collaboration-with-national-institute-of-allergy-and-infectious-diseases-niaid-301088202.html
SOURCE Regeneron Pharmaceuticals, Inc.