TARRYTOWN, N.Y. and
PARIS, Jan.
8, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi will accelerate and expand
investment for the clinical development of the PD-1 (programmed
cell death protein 1) antibody cemiplimab in oncology, and the
IL-4/IL-13 pathway-blocking antibody dupilumab in Type 2 allergic
diseases. Both of these breakthrough therapies have the potential
to benefit a number of different patient populations, and this
strategic investment will enable the companies to evaluate
cemiplimab and dupilumab in broader clinical development
programs.
Under the terms of the expansion, the investment in cemiplimab
will be increased to a minimum of $1.64
billion, an increase of approximately $1 billion over the initial 2015 agreement, and
Sanofi and Regeneron will continue to equally fund cemiplimab
development. The companies will also continue their investment in
other immuno-oncology programs under their existing Immuno-oncology
Discovery Agreement. Investigational cemiplimab is being studied as
monotherapy and in combination with other therapies in a wide range
of cancers including advanced skin cancers, non-small cell lung
cancer, cervical cancer and lymphomas, with more studies in other
indications planned to begin in 2018. The companies expect to
submit U.S. and EU regulatory applications for cemiplimab in
advanced cutaneous squamous cell carcinoma in the first quarter of
2018.
The additional investment in the dupilumab development program
will help accelerate planned new studies in chronic obstructive
pulmonary disease, peanut allergy and grass allergy, as well as in
patients who have multiple allergic conditions. These areas are in
addition to ongoing dupilumab clinical development in pediatric
atopic dermatitis, pediatric asthma, eosinophilic esophagitis and
nasal polyposis. Dupixent® (dupilumab) is approved for
the treatment of adults with moderate-to-severe atopic dermatitis
in the U.S. and EU, and a U.S. supplemental biologics license
application was submitted for uncontrolled, persistent asthma for
patients aged 12 and over in the fourth quarter of 2017. The
additional investment will also accelerate and expand development
of REGN3500, an IL-33 antibody, with studies expected to be
conducted in atopic dermatitis, asthma and chronic obstructive
pulmonary disease. The increased funding for dupilumab and REGN3500
will be pursuant to the existing Antibody License and Collaboration
Agreement between the companies.
"Cemiplimab has demonstrated strong pivotal clinical results in
advanced cutaneous squamous cell carcinoma and is a core backbone
of our immuno-oncology development program, both as a monotherapy
and in combination with other therapies. The increased funding will
enable us to investigate this important new therapy in a variety of
cancers as rapidly as possible," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "Similarly, dupilumab
has the potential to be a pipeline in a single product given its
unique activity on the IL-4/13 pathway, which is a critical driver
of Type 2 allergic inflammation. We look forward to rapidly
advancing a broad development program to further investigate the
potential of dupilumab to help multiple different patient
populations in need."
Regeneron has agreed to grant a limited waiver of the "lock-up"
in the Amended and Restated Investor Agreement between the
companies, so that Sanofi may sell a small percentage of the
Regeneron common stock it owns to fund a portion of the cemiplimab
and dupilumab development expansion. This waiver will allow Sanofi
to sell in private transactions to Regeneron up to an aggregate of
1.4 million shares of Regeneron common stock through the end of
2020, representing approximately 6 percent of the 23.9 million
shares of Regeneron common stock Sanofi currently owns. As of
October 20, 2017, there were 107.4
million shares of Regeneron capital stock outstanding. If Regeneron
decides not to purchase the shares, Sanofi will be allowed to sell
those shares on the open market, subject to certain volume and
timing limitations. Further details on the updated agreements are
available in Regeneron's current report on Form 8-K filed today.
Cemiplimab and dupilumab were invented by Regeneron using the
company's proprietary VelocImmune® technology
that yields optimized fully-human antibodies. Other than the
approved uses of Dupixent, cemiplimab, dupilumab and REGN3500 are
under clinical investigation and their safety and efficacy have not
been fully evaluated by any regulatory authority.
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to
any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all
your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- have asthma
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements. If you have asthma and are taking asthma
medicines, do not change or stop your asthma medicine without
talking to your healthcare provider.
DUPIXENT can cause serious side
effects, including:
- Allergic reactions. Stop using DUPIXENT and go to
the nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you
have any new or worsening eye problems, including eye pain or
changes in vision.
The most common side effects include injection site
reactions, eye and eyelid inflammation, including redness, swelling
and itching, and cold sores in your mouth or on your
lips.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. If your healthcare provider
decides that you or a caregiver can give DUPIXENT injections, you
or your caregiver should receive training on the right way to
prepare and inject DUPIXENT. Do not try to inject
DUPIXENT until you have been shown the right way by your healthcare
provider.
Please click here for the full Prescribing
Information. The patient information is available here.
INDICATION
DUPIXENT is used to treat adult patients with moderate-to-severe
atopic dermatitis (eczema) that is not well controlled with
prescription therapies used on the skin (topical), or who cannot
use topical therapies. DUPIXENT can be used with or without
topical corticosteroids. It is not known if DUPIXENT is safe and
effective in children. DUPIXENT is administered by subcutaneous
injection every two weeks after an initial loading dose
About Regeneron Pharmaceuticals, Inc.
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 six FDA-approved treatments and over a dozen
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its unique
VelociSuite® technologies, including
VelocImmune® to yield optimized fully human
antibodies, and ambitious initiatives such as The Regeneron
Genetics Center, 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 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
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, 2016.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
Regeneron Forward-Looking Statements and Use of Digital
Media
This news 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 cemiplimab (REGN2810) for the treatment of
various cancer indications; dupilumab in various Type 2 allergic
diseases; and REGN3500, an IL-33 antibody, in atopic dermatitis,
asthma, and chronic obstructive pulmonary disease); 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, such as cemiplimab, dupilumab, and
REGN3500; 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; 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, such as cemiplimab and dupilumab, including the
potential regulatory approval of dupilumab in patients aged 12 and
over with uncontrolled persistent asthma based on the supplemental
Biologics License Applications discussed in this news release; the
extent to which the results from the research and development
programs conducted by Regeneron or its collaborators may be
replicated in later studies and lead to therapeutic applications;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, research and clinical programs (such as the
clinical programs relating to cemiplimab, dupilumab, and REGN3500
referenced in this news release), and business, including those
relating to patient privacy; 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's
collaborators, suppliers, or other third parties to perform
filling, finishing, packaging, labelling, distribution, and other
steps related to Regeneron's products and product candidates;
coverage and reimbursement determinations by third-party payers,
including Medicare and Medicaid; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; unanticipated expenses; the costs
of developing, producing, and selling products; the ability of
Regeneron to meet any of its sales or other 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 HealthCare LLC, 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
proceedings relating to Praluent®(alirocumab) Injection,
the ultimate outcome of any such litigation proceedings, 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 United States Securities and
Exchange Commission, including its Form 10-K for the year
ended December 31, 2016 and its Form 10-Q for the
quarterly period ended September 30, 2017. 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
Sanofi:
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
|
Contacts
Regeneron:
Media
Relations
Arleen
Goldenberg
Tel: +1 (914)
847-3456
Mobile: +1 (914)
260-8788
arleen.goldenberg@regeneron.com
|
Investor
Relations
Manisha Narasimhan,
Ph.D.
Tel: +1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.