FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Paris and Tarrytown, NY - April 30, 2018 - The U.S. Food and Drug Administration (FDA) has accepted priority review
the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell
carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. Advanced CSCC is the
deadliest non-melanoma skin cancer . Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint
inhibitor PD-1 (programmed death 1) and was granted Breakthrough Therapy designation status by the FDA in September 2017. The
target action date for the FDA decision is October 28, 2018.
The BLA submission is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC
(EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients
with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. Topline results from
EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017
American Society of Clinical Oncology (ASCO) Annual Meeting. Updated results from both clinical trials will be presented at
upcoming medical congresses. Updated results from both clinical trials will be presented at the 2018 ASCO Annual
Meeting.
In the European Union, the European Medicines Agency accepted for review in April 2018 the Marketing Authorization
Application for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for
surgery.
Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any
regulatory authority.
About CSCC
Cutaneous squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the U.S., with the number
of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can
prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due
to the impact of the disease as it progresses . Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for
approximately 7,000 deaths in the U.S. each year. There are currently no FDA-approved treatments for advanced CSCC.
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 numerous 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, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite®
technologies, such as VelocImmune® which produces optimized fully-human antibodies, and 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.
|
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, 2017. 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 for the treatment of patients with metastatic cutaneous squamous cell carcinoma
("CSCC") or patients with locally advanced CSCC who are not candidates for surgery, or other potential indications; 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 for the treatment of patients with metastatic
CSCC or patients with locally advanced CSCC who are not candidates for surgery, or other potential indications (including any
potential approval by the U.S. Food and Drug Administration based on the Biologics License Application discussed in this news
release or by the European Medicines Agency based on the Marketing Authorization Application referenced in this news
release); 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, such as
cemiplimab; 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, 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, 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).
|