TARRYTOWN, N.Y. and
PARIS, Sept. 8, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced
that the U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy designation status to cemiplimab (REGN2810)
for the treatment of adults with metastatic cutaneous squamous cell
carcinoma (CSCC) and adults with locally advanced and unresectable
CSCC, the second deadliest skin cancer after melanoma. Cemiplimab
is an investigational human, monoclonal antibody targeting
PD-1.
Regeneron and Sanofi previously reported positive,
preliminary results for cemiplimab from two expansion cohorts
involving 26 advanced CSCC patients in a Phase 1 study of nearly
400 patients, at the American Society of Clinical Oncology (ASCO)
Annual Meeting in June 2017.
EMPOWER-CSCC 1, a Phase 2, potentially pivotal, single-arm,
open-label clinical trial of cemiplimab is currently enrolling
patients with metastatic CSCC and locally advanced and unresectable
CSCC. Cemiplimab was discovered using Regeneron's proprietary
VelocImmune® technology that yields optimized fully-human
antibodies, and is being jointly developed by Regeneron and Sanofi
under a global collaboration agreement. Pending data results, the
companies anticipate submitting a biologics license application for
cemiplimab with the FDA in the first quarter of 2018.
CSCC is the second most common type of skin cancer in
the United States. Although CSCC
has a good prognosis when caught early, it can prove especially
difficult to treat when it progresses to advanced stages. Patients
at this stage can be disfigured due to multiple surgeries to remove
CSCC tumors on the head, neck and other parts of the
body.1 CSCC is responsible for the most deaths among
non-melanoma skin cancer patients.
Breakthrough Therapy designation serves to expedite the
development and review of drugs that target serious or life-
threatening conditions. Drugs qualifying for this designation must
show credible evidence of a substantial improvement on a clinically
significant endpoint over available therapies, or over placebo if
there is no available therapy. The designation includes all of the
Fast Track program features, as well as more intensive FDA guidance
and discussion. The Breakthrough Therapy designation is distinct
from both accelerated approval and priority review, which can also
be granted to the same drug if relevant criteria are met.
Cemiplimab is currently under clinical development, and its
safety and efficacy has not been fully evaluated by any regulatory
authority.
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 nearly 30 years by physician-scientists, our
unique ability to consistently translate science into medicine has
led to six FDA-approved treatments and over a dozen product
candidates, 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, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary VelociSuite®
technologies, including VelocImmune® which yields 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, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
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
patients with metastatic or locally advanced and unresectable
cutaneous squamous cell carcinoma (CSCC) or other potential
indications; 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; 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, including the impact (if
any) of the Breakthrough Therapy designation status granted
to cemiplimab for the treatment of patients with metastatic or
locally advanced and unresectable CSCC by the U.S. Food and Drug
Administration; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products, research and clinical
programs (such as the clinical program relating to cemiplimab
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
relating to Praluent®(alirocumab) Injection, the
permanent injunction granted by the United States District
Court for the District of Delaware that, if upheld on appeal,
would prohibit Regeneron and Sanofi from marketing,
selling, or commercially manufacturing Praluent in the
United States, the outcome of any
appeals regarding such injunction, the ultimate outcome of such
litigation, 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 June 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).
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 regarding
the clinical development of and potential marketing approvals for
the product. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans", "would be" 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 of the product, 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 the product or biological application
that may be filed for the product as well as their decisions
regarding labeling and other matters that could affect the
availability or commercial potential of the product, the absence of
guarantee that the product if approved will be commercially
successful, risks associated with intellectual property, future
litigation, the future approval and commercial success of
therapeutic alternatives, and volatile economic conditions, as well
as those risks 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.
Contacts
Sanofi:
|
Contacts
Regeneron:
|
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
|
Media
Relations
Daren Kwok
Tel: +1 (914)
847-1328
daren.kwok@regeneron.com
Investor
Relations
Manisha Narasimhan,
Ph.D.
Tel: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
1 Medscape. Cutaneous Squamous Cell Carcinoma.
Available at:
http://emedicine.medscape.com/article/1965430-overview. Last
Accessed: Last Accessed: August 2,
2017.
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content:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-cemiplimab-regn2810-has-received-fda-breakthrough-therapy-designation-for-advanced-cutaneous-squamous-cell-carcinoma-300516208.html
SOURCE Regeneron Pharmaceuticals, Inc.