TARRYTOWN, N.Y. and
PARIS, Dec.
10, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced their intent to simplify their antibody collaboration for
Kevzara® (sarilumab) and Praluent®
(alirocumab) by restructuring into a royalty-based agreement. Under
the proposed restructuring, Sanofi is expected to gain sole global
rights to Kevzara and sole ex-U.S. rights to Praluent. Regeneron is
expected to gain sole U.S. rights to Praluent. Under the proposed
terms of the agreement, each party will be solely responsible for
funding development and commercialization expenses in their
respective territories. These changes are expected to increase
efficiency and streamline operations for the products. The existing
collaboration relating to Dupixent® (dupilumab) will
remain unchanged following the restructuring. Completion of the
proposed arrangement is expected to be finalized in the first
quarter of 2020.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for 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, infectious diseases, pain
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, including
VelocImmune® which uses a unique
genetically-humanized mouse 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.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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 Regeneron's products, product
candidates, and research and clinical programs now underway or
planned, including without limitation Dupixent®
(dupilumab), Praluent® (alirocumab), and
Kevzara® (sarilumab); the potential for any
license or collaboration agreement, including Regeneron's
agreements with Sanofi (such as the antibody license and
collaboration agreement, as amended from time to time), Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; whether the proposed restructuring of
the antibody collaboration with Sanofi discussed in this press
release (the "Proposed Restructuring") will be completed on the
currently contemplated terms, in the expected time
frame, or at all; the impact of the Proposed Restructuring on
Regeneron's business, operating results, and financial condition;
unforeseen safety issues resulting from the administration of
products and product candidates in patients, including serious
complications or side effects in connection with the use of
Regeneron's product candidates in clinical trials; 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 likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's late-stage product candidates and new
indications for marketed products; ongoing regulatory obligations
and oversight impacting Regeneron's marketed products, research and
clinical programs, and business, including those relating to
patient privacy; 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; competing drugs and product
candidates that may be superior 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) on the commercial success of Regeneron's
products and product candidates; 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; the availability and extent of reimbursement of
the Company'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; 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; 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 and Praluent), 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 fiscal year ended
December 31, 2018 and its Form 10-Q
for the quarterly period ended September 30,
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).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances,
risks associated with intellectual property and any related pending
or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic conditions, the impact of cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2018. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
Tel: +1 (914)
847-5018
sarah.cornhill@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
Sanofi
Contacts:
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Ashleigh.Koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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content:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-intent-to-restructure-antibody-collaboration-for-kevzara-sarilumab-and-praluent-alirocumab-300972220.html
SOURCE Regeneron Pharmaceuticals, Inc.