TARRYTOWN, N.Y. and
PARIS, Oct.
8, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi will present a diverse set of data from
their joint clinical program investigating Libtayo®
(cemiplimab-rwlc) at the ESMO 2018 Congress (European Society for
Medical Oncology) from October 19 to
23 in Munich, Germany.
These data span six different tumor types, including non-small cell
lung cancer (NSCLC), cervical cancer, cutaneous squamous cell
carcinoma (CSCC), hepatocellular carcinoma (HCC), head and neck
squamous cell carcinoma (HNSCC) and basal cell carcinoma (BCC).
Libtayo is a fully-human monoclonal antibody targeting the immune
checkpoint receptor PD-1 (programmed cell death protein-1).
"Following the U.S. FDA approval of Libtayo in advanced CSCC, we
remain focused on pursuing science that has the potential to change
treatment paradigms in oncology," said Israel Lowy, M.D., Ph.D., Vice President of
Global Clinical Development and Head of Translational Science and
Clinical Oncology, Regeneron. "At ESMO, we look forward to sharing
new data that support our rationale for pursuing registrational
trials of Libtayo in lung, cervical and skin cancers."
All six of the abstracts accepted at ESMO focus on ongoing
Libtayo clinical trials.
"Three years ago, Sanofi began its immuno-oncology collaboration
with Regeneron with the shared vision to address significant unmet
needs across various cancer types," said Joanne Lager, M.D., Head of Oncology
Development, Sanofi. "This year's data being presented at ESMO are
a testament to our commitment to patients and the potential to make
our vision a reality."
Among the joint Regeneron and Sanofi presentations are new
clinical data from a Phase 1 expansion cohort investigating Libtayo
in combination with radiotherapy in advanced NSCLC as well as
longer-term follow-up data from the advanced CSCC expansion cohorts
in the Phase 1 trial. Additional abstracts will feature initial
data from Phase 1 expansion cohorts investigating Libtayo in
cervical cancer, HCC and HNSCC, alongside a trial-in-progress
update on the potentially pivotal Phase 2 trial in BCC.
Regeneron and Sanofi joint presentations at ESMO include:
- Cemiplimab, a human PD-1 monoclonal antibody, in patients
with recurrent or metastatic cervical cancer: Interim data from
phase 1 cohorts
Danny Rischin Oct 20/12:30-13:30/958P
- Cemiplimab, a human monoclonal anti-PD-1, plus
radiotherapy in advanced non-small cell lung cancer (NSCLC):
Results from a Phase 1 expansion cohort (EC 2)
Victor Moreno, Oct 20/12:30-13:30/1162P
- Phase 1 study of cemiplimab, a human monoclonal anti-PD-1,
in patients with unresectable locally advanced or metastatic
cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy
and safety data
Taofeek K. Owonikoko, Oct
21/12:45-13:45/1292P
- Cemiplimab, a human monoclonal anti-PD-1, in patients with
advanced or metastatic hepatocellular carcinoma (HCC): Data from an
expansion cohort in a Phase 1 study
Michael J. Pishvaian,
Oct 20/12:30-13:30/1151P
- Phase 1 expansion cohort results of cemiplimab, a human PD-1
monoclonal antibody, in combination with radiotherapy,
cyclophosphamide and GM-CSF, in patients with recurrent or
metastatic head and neck squamous cell carcinoma (R/M
HNSCC)
Hani Babiker, Oct 20/12:30-13:30/1171P
- Phase 2 study of cemiplimab, a human monoclonal anti-PD-1,
in patients with advanced basal cell carcinoma (BCC) who
experienced progression of disease on, or were intolerant of prior
hedgehog pathway inhibitor therapy
Karl D. Lewis, Oct 20/12:30-13:30/1240TiP
Libtayo is being developed jointly by Regeneron and Sanofi under
a global collaboration agreement, and was invented by Regeneron
using the company's proprietary VelocImmune®
technology that yields optimized fully-human antibodies. The
potential uses of Libtayo as a treatment for NSCLC, cervical
cancer, BCC, HCC and HNSCC are investigational, and its safety and
efficacy have not been evaluated by any regulatory authority for
these cancers.
Libtayo is currently approved in the U.S. for the treatment of
patients with metastatic CSCC or locally advanced CSCC who are not
candidates for curative surgery or curative radiation. The generic
name for Libtayo in the U.S. is cemiplimab-rwlc, with rwlc as the
suffix designated in accordance with Nonproprietary Naming of
Biological Products Guidance for Industry issued by the U.S. Food
and Drug Administration. Regeneron and Sanofi Genzyme, the
specialty care global business unit of Sanofi, market Libtayo
jointly in the U.S. The safety and efficacy of Libtayo have not
been evaluated by any regulatory authority outside of the U.S. for
the treatment of advanced CSCC.
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 a type of skin
cancer 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.
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 symptoms of the following problems or these symptoms
get worse:
- Lung problems (pneumonitis). Signs and symptoms
of pneumonitis may include new or worsening cough, shortness of
breath, and chest pain.
- Intestinal problems (colitis) that can lead to tears or
holes in your intestine. Signs and symptoms of colitis
may include diarrhea (loose stools) or more frequent bowel
movements than usual; stools that are black, tarry, sticky or that
have blood or mucus; and severe stomach-area (abdomen) pain or
tenderness.
- Liver problems (hepatitis). Signs and symptoms of
hepatitis may include yellowing of your skin or the whites of your
eyes, severe nausea or vomiting, pain on the right side of your
stomach area (abdomen), drowsiness, dark urine (tea colored),
bleeding or bruising more easily than normal, and feeling less
hungry than usual.
- Hormone gland problems (especially the adrenal glands,
pituitary, thyroid and pancreas). Signs and symptoms that your
hormone glands are not working properly may include headaches that
will not go away or unusual headaches, rapid heartbeat, increased
sweating, extreme tiredness, weight gain or weight loss, dizziness
or fainting, feeling more hungry or thirsty than usual, hair loss,
feeling cold, constipation, deeper voice, very low blood pressure,
urinating more often than usual, nausea or vomiting, stomach-area
(abdomen) pain, and changes in mood or behavior, such as decreased
sex drive, irritability, or forgetfulness.
- Kidney problems, including nephritis and kidney failure.
Signs of these problems may include decrease in your amount of
urine, blood in your urine, swelling in your ankles, and loss of
appetite.
- Skin problems. Signs of these problems may include rash,
itching, skin blistering, and painful sores or ulcers in the mouth,
nose, throat, or genital area.
- Problems in other organs. Signs of these problems may
include headache, tiredness or weakness, sleepiness, changes in
heartbeat (such as beating fast, seeming to skip a beat, or a
pounding sensation), confusion, fever, muscle weakness, balance
problems, nausea, vomiting, stiff neck, memory problems, seizures
(encephalitis), swollen lymph nodes, rash or tender lumps on skin,
cough, shortness of breath, vision changes, or eye pain
(sarcoidosis), seeing or hearing things that are not there
(hallucinations), severe muscle weakness, low red blood cells
(anemia), bruises on the skin or bleeding, and changes in
eyesight.
- Rejection of a transplanted organ. Your doctor should
tell you what signs and symptoms you should report and monitor you,
depending on the type of organ transplant that you have had.
- Infusion (IV) reactions that can sometimes be severe
and life-threatening. Signs of these problems may include
chills or shaking, itching or rash, flushing, shortness of breath
or wheezing, dizziness, fever, feeling of passing out, back or neck
pain, and facial swelling.
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 delay or completely stop treatment 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 had an organ transplant;
- have lung or breathing problems;
- have liver or kidney problems;
- have diabetes;
- 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 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 accompanying full Prescribing Information,
including Medication Guide.
What is Libtayo?
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called cutaneous squamous cell carcinoma (CSCC)
that has spread or cannot be cured by surgery or radiation.
It is not known if Libtayo is safe and effective in
children.
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 seven 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 diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neuromuscular
diseases, 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.
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, Empowering Life
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
Libtayo® (cemiplimab-rwlc) for the treatment of patients
with cutaneous squamous cell carcinoma, non-small cell lung cancer
("NSCLC"), cervical cancer, hepatocellular carcinoma ("HCC"), head
and neck squamous cell carcinoma ("HNSCC"), basal cell carcinoma
("BCC"), and other potential indications; the likelihood and timing
of achieving any of Regeneron's anticipated clinical development
milestones; 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 (such as Libtayo) in
clinical trials; the likelihood and timing of possible regulatory
approval and commercial launch of Regeneron's late-stage product
candidates and new indications for marketed products, including
without limitation Libtayo for the treatment of NSCLC, cervical
cancer, HCC, HNSCC, BCC, and other potential indications; the
extent to which the results from the research and development
programs conducted by Regeneron or its collaborators may be
replicated in other studies and lead to therapeutic applications;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products (such as Libtayo), research and clinical
programs, and business, including those relating to patient
privacy; 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; 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; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties to perform
filling, finishing, packaging, labeling, distribution, and other
steps related to Regeneron's products and product candidates;
coverage and reimbursement determinations by third-party payers,
including Medicare and Medicaid; 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 or collaboration 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 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 EYLEA® (aflibercept) Injection,
Dupixent® (dupilumab) Injection, 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 U.S. Securities
and Exchange Commission, including its Form 10-K for the fiscal
year ended December 31, 2017 and its
Form 10-Q for the quarterly period ended June 30, 2018. 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, 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 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, to
complete related transactions 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
Contacts:
|
Sanofi
Contacts:
|
|
|
Media
Relations
Daren Kwok
Tel: +1 (914)
847-1328
daren.kwok@regeneron.com
|
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
ashleigh.koss@sanofi.com
|
|
|
Investor
Relations
Manisha Narasimhan,
Ph.D.
Tel: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
Investor
Relations George
Grofik Tel: +33 (0)1 53 77 45
45 ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.