TARRYTOWN, N.Y., July 7, 2020 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that, as part
of Operation Warp Speed, 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, and the Department of Defense Joint
Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply
REGN-COV2. REGN-COV2 is Regeneron's investigational double antibody
cocktail that is currently 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 infection.
Regeneron began scaling up manufacturing of REGN-COV2 at
business risk in spring of 2020. This agreement supports continued
manufacturing so that the product could be made available
immediately in the United States
if clinical trials are successful and the U.S. Food and Drug
Administration (FDA) grants Emergency Use Authorization (EUA) or
product approval. The agreement covers a fixed number of bulk lots
that are intended to be completed in the fall of 2020, as well as
fill/finish and storage activities. The ongoing REGN-COV2
clinical program is evaluating
multiple dosages and will help establish the exact
number of potential treatment doses (estimated range of 70,000 to
300,000) or prevention doses (estimated range of 420,000 to
1,300,000) available from these lots in total. Initial doses may be
ready as early as end of summer. If EUA or product approval is
granted, the government has committed to making doses from these
lots available to the American people at no cost and would be
responsible for their distribution.
"Regeneron's thirty years of investment in our
innovative VelociSuite®
antibody discovery and
development technologies and our large-scale
manufacturing facilities, coupled with the expertise and passion of
our people, has enabled us to move the REGN-COV2 program forward at
remarkable speed," said Leonard S.
Schleifer, M.D., Ph.D., Co-Founder, President and Chief
Executive Officer of Regeneron. "We made the decision early on to
begin large-scale manufacturing at our own risk in order to ensure
that product would be available immediately if our
clinical trials prove successful and an Emergency Use
Authorization is granted. This manufacturing and supply
agreement with BARDA and the Department of Defense could help
REGN-COV2 reach many people quickly, hopefully helping to change
the course of this deadly and still-raging pandemic."
Regeneron continues to work to maximize manufacturing capacity
of REGN-COV2 within Regeneron and with potential
partners.
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 identified 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 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, and
suppliers, 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; whether Regeneron will be able to meet any drug product
manufacturing milestones set forth in the manufacturing and supply
agreement with the Biomedical Advanced Research and Development
Authority and the Joint Project Executive Office for Chemical,
Biological, Radiological and Nuclear Defense with the U.S.
Department of Defense (collectively, the "U.S. Government")
discussed in this press release (the "Manufacturing and Supply
Agreement"), the amount of payments (if any) Regeneron may receive
pursuant to the Manufacturing and Supply Agreement, and whether the
Manufacturing and Supply Agreement is terminated by the U.S.
Government or otherwise prior to completion; 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
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SOURCE Regeneron Pharmaceuticals, Inc.