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
|
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SOURCE Regeneron Pharmaceuticals, Inc.