TARRYTOWN, N.Y., Aug. 19, 2020 /PRNewswire/ --
REGN-COV2 is Regeneron's two-antibody 'cocktail' currently in
late-stage clinical trials for the treatment and prevention of
COVID-19 infection
The companies will collaborate on developing and
manufacturing REGN-COV2; Regeneron will distribute REGN-COV2 in the
U.S. and Roche will be responsible for distribution outside the
U.S.
Under this agreement, overall capacity of REGN-COV2 is
expected to increase by at least three and a half times,
substantially increasing the number of doses available to patients
in the U.S. and around the world
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Roche
announced today that they are joining forces in the fight against
COVID-19 to develop, manufacture and distribute REGN-COV2,
Regeneron's investigational anti-viral antibody cocktail, to people
around the globe. REGN-COV2 could provide a much-needed treatment
option for people already experiencing symptoms of COVID-19, and
also has the potential to prevent infection in people exposed to
the virus, thus slowing the spread of the global
pandemic. This collaboration is expected to increase supply of
REGN-COV2 to at least three and a half times the current capacity,
with the potential for even further expansion.
REGN-COV2 is currently being studied in two Phase 2/3 clinical
trials for the treatment of COVID-19 and in a Phase 3 trial for the
prevention of COVID-19 in household contacts of infected
individuals. If it proves safe and effective in clinical trials and
regulatory approvals are granted, Regeneron will distribute and
record sales for REGN-COV2 in the U.S. and Roche will be
responsible for distribution outside the U.S.
"We are excited about the potential for one medicine to serve
both as a treatment for those infected as well as protection for
people exposed to the virus. REGN-COV2 could be a critical line of
defense against the COVID-19 pandemic," said Bill Anderson, Chief Executive Officer of Roche
Pharmaceuticals. "We're committing our manufacturing expertise and
capacity, and our global distribution network, to bring Regeneron's
potential antibody combination to as many people around the world
as we possibly can."
"Regeneron has progressed the REGN-COV2 research and development
program at record speed and worked tirelessly to maximize our
in-house manufacturing capacity," said Leonard S. Schleifer, M.D., Ph.D., President and
Chief Executive Officer of Regeneron. "This major collaboration
with Roche provides important scale and global expertise to bring
REGN-COV2 to many more patients in the
United States and around the globe."
Under the terms of the agreement, each company has committed to
dedicate a certain manufacturing capacity to REGN-COV2 each year,
and the collaborators have already begun the technology transfer
process. Each company will bear its own distribution expenses in
their designated territories. The collaborators will jointly
fund and execute the ongoing Phase 3 prevention and Phase 1 healthy
volunteer safety studies, as well as any additional global studies
to evaluate further the potential for REGN-COV2 in treating or
preventing COVID-19. Roche will be primarily responsible for
securing regulatory approvals outside the U.S., following the
initial European Medicines Agency (EMA) approval, and conducting
any additional studies specifically required for approval by
regulators outside the U.S.
About REGN-COV2
REGN-COV2 was designed specifically by
Regeneron scientists to block infectivity of SARS-CoV-2, the virus
that causes COVID-19. They 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 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 recent
Science publications.
REGN-COV2's development, manufacturing and clinical trials have
been funded in part by 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.
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, 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 REGN-COV2 (Regeneron's
investigational two-antibody cocktail for the treatment and
prevention of COVID-19); 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; 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; whether the technology
transfer process discussed in this press release will be completed
in the expected time frame or at all and whether the collaboration
with Roche discussed in this press release will result in an
increase in the current manufacturing and distribution capacity for
REGN-COV2; 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; 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, 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;
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), as well as
Regeneron's collaboration with Roche discussed in this press
release, to be cancelled or terminated without any 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 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 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
View original
content:http://www.prnewswire.com/news-releases/regeneron-and-roche-collaborate-to-significantly-increase-global-supply-of-regn-cov2-investigational-antibody-cocktail-for-covid-19-301114443.html
SOURCE Regeneron Pharmaceuticals, Inc.