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REGENERON AND SANOFI PROVIDE REGULATORY UPDATE ON LIBTAYO® (CEMIPLIMAB-RWLC) IN
ADVANCED CERVICAL CANCER
--------------------------------------------------------------------------------
News provided by
Regeneron Pharmaceuticals, Inc.
Jan 28, 2022, 07:00 ET
SHARE THIS ARTICLE
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TARRYTOWN, N.Y. and PARIS, Jan. 28, 2022 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the voluntary
withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo®
(cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical
cancer. The decision was made after the companies and the U.S. Food and Drug
Administration (FDA) were not able to align on certain post-marketing studies.
Discussions with regulatory authorities outside of the U.S. are ongoing.
About Cervical Cancer
It is estimated that approximately 570,000 people are diagnosed with cervical
cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are
14,500 new cases diagnosed annually and approximately 4,000 die each year. Since
we filed our sBLA, another PD-1 inhibitor was approved as first-line treatment
for patients with persistent, recurrent or metastatic cervical tumors that
express PD-L1. The use of Libtayo in advanced cervical cancer is not approved by
the FDA.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint
receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block
cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo
is indicated in certain patients with advanced basal cell carcinoma (BCC),
advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell
lung cancer (NSCLC).
The extensive clinical program for Libtayo is focused on difficult-to-treat
cancers. Libtayo is currently being investigated in trials as a monotherapy, as
well as in combination with either conventional or novel therapeutic approaches
for other solid tumors and blood cancers. These potential uses are
investigational, and their safety and efficacy have not been evaluated by any
regulatory authority.
Libtayo, which was invented using Regeneron's proprietary VelocImmune®
technology, is being jointly developed by Regeneron and Sanofi under a global
collaboration agreement.
U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat people with:
* A type of skin cancer called advanced CSCC that has spread or cannot be cured
by surgery or radiation.
* A type of skin cancer called BCC:
* That cannot be removed by surgery (locally advanced BCC) and have received
treatment with a hedgehog inhibitor (HHI), or cannot receive treatment
with an HHI.
* That has spread (metastatic BCC) and have received treatment with an HHI,
or cannot receive treatment with an HHI. This use is approved based on how
many patients responded to treatment and how long they responded. Studies
are ongoing to provide additional information about clinical benefit.
* A type of lung cancer called NSCLC. Libtayo may be used as your first
treatment when your lung cancer has not spread outside your chest (locally
advanced lung cancer) and you cannot have surgery or chemotherapy with
radiation, or your lung cancer has spread to other areas of your body
(metastatic lung cancer), and your tumor tests positive for high "PD-L1" and
your tumor does not have an abnormal "EGFR", "ALK" or "ROS1" gene.
It is not known if Libtayo is safe and effective in children.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered
mouse platform endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's President and Chief
Scientific Officer George D. Yancopoulos was a graduate student with his
mentor Frederick W. Alt in 1985, they were the first to envision making such a
genetically humanized mouse, and Regeneron has spent decades inventing and
developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and
his team have used VelocImmune technology to create approximately a quarter of
all original, FDA-approved or authorized fully human monoclonal antibodies
currently available. This includes REGEN-COV®(casirivimab and imdevimab),
Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent®(alirocumab),
Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab,
maftivimab, and odesivimab-ebgn).
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune
system. Libtayo can cause your immune system to attack normal organs and tissues
in any area of your body and can affect the way they work. These problems can
sometimes become severe or life-threatening and can lead to death. You can have
more than one of these problems at the same time. These problems may happen
anytime during treatment or even after your treatment has ended.
Call or see your healthcare provider right away if you develop any new or
worsening signs or symptoms, including:
* Lung problems: cough, shortness of breath, or chest pain
* Intestinal problems: diarrhea (loose stools) or more frequent bowel movements
than usual, stools that are black, tarry, sticky or have blood or mucus, or
severe stomach area (abdomen) pain or tenderness
* Liver problems: yellowing of your skin or the whites of your eyes, severe
nausea or vomiting, pain on the right side of your stomach area (abdomen),
dark urine (tea colored), or bleeding or bruising more easily than normal
* Hormone gland problems: headache that will not go away or unusual headaches,
eye sensitivity to light, eye problems, rapid heartbeat, increased sweating,
extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty
than usual, urinating more often than usual, hair loss, feeling cold,
constipation, your voice gets deeper, dizziness or fainting, or changes in
mood or behavior, such as decreased sex drive, irritability, or forgetfulness
* Kidney problems: decrease in your amount of urine, blood in your urine,
swelling of your ankles, or loss of appetite
* Skin problems: rash, itching, skin blistering or peeling, painful sores or
ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms,
or swollen lymph nodes
* Problems can also happen in other organs and tissues. These are not all of
the signs and symptoms of immune system problems that can happen with
Libtayo. Call or see your healthcare provider right away for any new or
worsening signs or symptoms, which may include: chest pain, irregular
heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness,
memory problems, changes in mood or behavior, stiff neck, balance problems,
tingling or numbness of the arms or legs, double vision, blurry vision,
sensitivity to light, eye pain, changes in eyesight, persistent or severe
muscle pain or weakness, muscle cramps, low red blood cells, or bruising
* Infusion reactions that can sometimes be severe. Signs and symptoms of
infusion reactions may include: nausea, chills or shaking, itching or rash,
flushing, shortness of breath or wheezing, dizziness, feel like passing out,
fever, back or neck pain, or facial swelling.
* Rejection of a transplanted organ. Your healthcare provider should tell you
what signs and symptoms you should report and monitor you, depending on the
type of organ transplant that you have had.
* Complications, including graft-versus-host disease (GVHD), in people who have
received a bone marrow (stem cell) transplant that uses donor stem cells
(allogeneic). These complications can be serious and can lead to death. These
complications may happen if you underwent transplantation either before or
after being treated with Libtayo. Your healthcare provider will monitor you
for these complications.
Getting medical treatment right away may help keep these problems from becoming
more serious.
Your healthcare provider will check you for these problems during your treatment
with Libtayo. Your healthcare provider may treat you with corticosteroid or
hormone replacement medicines. Your healthcare provider may also need to delay
or completely stop treatment with Libtayo if you have severe side effects.
Before you receive Libtayo, tell your healthcare provider about all your medical
conditions, including if you:
* have immune system problems such as Crohn's disease, ulcerative colitis, or
lupus
* have received an organ transplant
* have received or plan to receive a stem cell transplant that uses donor stem
cells (allogeneic)
* have a condition that affects your nervous system, such as myasthenia gravis
or Guillain-Barré syndrome are pregnant or plan to become pregnant. Libtayo
can harm your unborn baby
Females who are able to become pregnant:
* Your healthcare provider will give you a pregnancy test before you start
treatment.
* You should use an effective method of birth control during your treatment
and for at least 4 months after your last dose of Libtayo. Talk with your
healthcare provider about birth control methods that you can use during
this time.
* Tell your healthcare provider right away if you become pregnant or think
you may be pregnant during treatment with Libtayo.
* are breastfeeding or plan to breastfeed. It is not known if Libtayo passes
into your breast milk. Do not breastfeed during treatment and for at least 4
months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Libtayo include muscle or bone pain, tiredness,
rash, and diarrhea. These are not all the possible side effects of Libtayo. Call
your doctor for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron
Pharmaceuticals and Sanofi at
1-877-542-8296.
Please see full Prescribing Information, including Medication Guide.
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 nine FDA-approved
treatments and numerous product candidates in development, almost 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, hematologic conditions, 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.
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.
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 impact of SARS-CoV-2 (the virus that
has caused the COVID-19 pandemic) on Regeneron's business and its employees,
collaborators, and suppliers and other third parties on which Regeneron relies,
Regeneron's and its collaborators' ability to continue to conduct research and
clinical programs, Regeneron's ability to manage its supply chain, net product
sales of products marketed or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and therapeutic
applications of Regeneron's Products and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively, "Regeneron's
Product Candidates") and research and clinical programs now underway or planned,
including without limitation Libtayo® (cemiplimab) as a second-line treatment
for patients with advanced cervical cancer; the likelihood, timing, and scope of
possible regulatory approval and commercial launch of Regeneron's Product
Candidates and new indications for Regeneron's Products, such as possible
regulatory approval of Libtayo as a second-line treatment for patients with
advanced cervical cancer outside of the U.S. as well as Libtayo (as a
monotherapy or in combination with conventional or novel therapeutic approaches,
as applicable) for the treatment of other solid tumors and blood cancers and
other potential indications; uncertainty of the utilization, market acceptance,
and commercial success of Regeneron's Products and Regeneron's Product
Candidates and the impact of studies (whether conducted by Regeneron or others
and whether mandated or voluntary), including the studies discussed or
referenced in this press release, on any of the foregoing or any potential
regulatory approval of Regeneron's Products (such as Libtayo) and Regeneron's
Product Candidates; the ability of Regeneron's collaborators, licensees,
suppliers, or other third parties (as applicable) to perform manufacturing,
filling, finishing, packaging, labeling, distribution, and other steps related
to Regeneron's Products and Regeneron's Product Candidates; the ability of
Regeneron to manage supply chains for multiple products and product candidates;
safety issues resulting from the administration of Regeneron's Products (such as
Libtayo) and Regeneron's Product Candidates in patients, including serious
complications or side effects in connection with the use of Regeneron's Products
and Regeneron's Product Candidates in clinical trials; 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 Regeneron's Product Candidates, including without limitation
Libtayo; ongoing regulatory obligations and oversight impacting Regeneron's
Products, research and clinical programs, and business, including those relating
to patient privacy; 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, or more cost effective than, Regeneron's Products and
Regeneron's Product Candidates; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
collaborators or licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic applications,
or regulatory approval; 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, collaboration, or
supply 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; 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 EYLEA® (aflibercept) Injection, Dupixent® (dupilumab),
Praluent® (alirocumab), and REGEN-COV® (casirivimab and imdevimab)), 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, 2020 and its Form 10-Q for the quarterly
period ended September 30, 2021. 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 or otherwise) 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 marketing and other potential of the
product, or regarding potential future revenues from the product.
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, unexpected regulatory actions or delays, or
government regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not be
commercially successful, the uncertainties inherent in research and development,
including future clinical data and analysis of existing clinical data relating
to the product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with intellectual
property and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the impact that
COVID-19 will have on us, our customers, suppliers, vendors, and other business
partners, and the financial condition of any one of them, as well as on our
employees and on the global economy as a whole. Any material effect of COVID-19
on any of the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are not currently
aware and may exacerbate other previously identified risks. The risks and
uncertainties also include the uncertainties 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, 2020. Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information or
statements.
Contacts:
Regeneron Contacts:
Sanofi Contacts:
Media Relations
Daren Kwok
Tel: +1 914-847-1328
daren.kwok@regeneron.com
Investor Relations
Vesna Tosic
Tel: +1 914-847-5443
vesna.tosic@regeneron.com
Media Relations
Sally Bain
Tel: +1 781-264-1091
sally.bain@sanofi.com
Investor Relations Paris
Eva Schaefer-Jansen
Arnaud Delepine
Yvonne Naughton
Investor Relations North America
Felix Lauscher
Fara Berkowitz
Suzanne Greco
IR main line:
Tel: +33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
SOURCE Regeneron Pharmaceuticals, Inc.
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