TARRYTOWN, N.Y., March 17, 2020 /PRNewswire/ --
Regeneron has identified hundreds of virus-neutralizing
antibodies; plans to initiate large-scale manufacturing by
mid-April with antibody cocktail therapy
Potential to enter human clinical studies by early
summer
This program is in addition to Regeneron's separate ongoing
clinical program evaluating Kevzara® (sarilumab, an IL-6
receptor antibody) in severe COVID-19 patients
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced the latest progress in its efforts to discover and
develop a novel multi-antibody cocktail that can be administered as
prophylaxis before exposure to the SARS-CoV-2 virus or as treatment
for those already infected. Regeneron scientists have now isolated
hundreds of virus-neutralizing, fully human antibodies from the
company's VelocImmune® mice, which have been
genetically-modified to have a human immune system. Regeneron has
also isolated antibodies from humans who have recovered from
COVID-19, in order to maximize the pool of potentially potent
antibodies. From this large pool of candidates, Regeneron will
select the top two antibodies for a 'cocktail' treatment based on
potency and binding ability to the SARS-CoV-2 spike protein, as
well as other desirable qualities. Using a multi-antibody approach
allows for targeting of different parts of the virus and may help
protect against multiple viral variants. Regeneron previously used
these technologies to rapidly develop a successful
treatment for Ebola virus infection, which is currently under
review by the U.S. Food and Drug Administration.
In order to meet the pressing public health need, Regeneron is
applying its VelociMab® technology to prepare
manufacturing-ready cell lines as lead antibodies are selected, so
that clinical-scale production can begin immediately. The company
is working toward the goal of producing hundreds of thousands of
prophylactic doses per month by the end of summer and hopes to have
smaller quantities available for initial clinical testing at the
beginning of the summer. The company is working with the U.S.
Health & Human Services' Biomedical Advanced Research and
Defense Authority (BARDA) to increase capacity even further.
"Our three decades of investment in our VelociSuite
antibody technologies, which accelerate and improve the traditional
drug discovery process, have hopefully prepared us for this
critical time and to meet this important challenge," said
George D. Yancopoulos, M.D., Ph.D.,
Co-founder, President and Chief Scientific Officer of Regeneron.
"Given the tremendous interest and concern around the COVID-19
pandemic, we will be providing regular and transparent updates on
our discovery and development programs. I want to recognize our
incredible team, which is working around the clock to develop
needed solutions to this global health crisis."
All coronaviruses have a single glycoprotein on the virus
surface called the spike protein, which is the protein on the virus
cell surface that binds to the host cell and is required for
infectivity. Regeneron's SARS-CoV-2 antibodies will target the
spike protein in order to block its interaction with the host cell,
and thus neutralize the virus.
"I'm so proud to be part of this cross-company team, which
delivered a novel and effective fully human antibody treatment for
Ebola in record time and is making every effort to once again rise
to this unprecedented challenge," said Christos Kyratsous, Ph.D., Vice President of
Research, Infectious Diseases and Viral Vector Technologies at
Regeneron.
Yesterday, Regeneron and its collaborator Sanofi also announced
the initiation of a Phase 2/3 clinical trial evaluating
Kevzara® (sarilumab) in patients hospitalized with
severe COVID-19. Kevzara inhibits interleukin-6 (IL-6), which may
play a role in driving the overactive inflammatory response in the
lungs of patients who are severely or critically ill with
COVID-19.
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.
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 nature, timing,
and possible success and therapeutic applications of products
marketed by Regeneron and/or its collaborators (collectively,
"Regeneron's Products") and Regeneron's product candidates and
research and clinical programs now underway or planned, including
without limitation Regeneron's novel antibody cocktail for
the prevention and treatment of the SARS-CoV-2 virus (the "COVID-19
Multi-antibody Therapy") and Kevzara® (sarilumab) for
the treatment of patients with severe COVID-19; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's product candidates and new indications for
Regeneron's Products, such as the COVID-19 Multi-antibody Therapy
and Kevzara for the treatment of patients with severe COVID-19; the
likelihood and timing of achieving any of the anticipated
development and production milestones referenced in this press
release; unforeseen safety issues resulting from the administration
of Regeneron's Products and product candidates (such as Kevzara and
the COVID-19 Multi-antibody Therapy) 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 Kevzara and the
COVID-19 Multi-antibody Therapy; 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, labeling, 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.
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).
Regeneron
Contacts:
Media
Relations
Alexandra
Bowie
Tel: +1 (914)
847-3407
alexandra.bowie@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.