TARRYTOWN, N.Y. and
PARIS, Sept. 11, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the pivotal Phase 3 LIBERTY ASTHMA QUEST study of
dupilumab in a broad population of patients with uncontrolled,
persistent asthma met its two primary endpoints. Dupilumab, when
added to standard therapies, reduced severe asthma attacks
(exacerbations) and improved lung function. At 52 weeks, in the 300
mg dose group, dupilumab reduced severe asthma attacks by 46
percent in the overall population, 60 percent in patients with 150
eosinophilic cells/microliter or greater, and 67 percent in
patients with 300 eosinophilic cells/microliter or greater (p less
than 0.001 for all groups). At 12 weeks, in the 300 mg dupilumab
dose group, mean improvement in lung function over placebo as
assessed by forced expiratory volume over one second
(FEV1) was 130 mL (9 percent) in the overall population,
210 mL (11 percent) in patients with 150 eosinophilic
cells/microliter or greater, and 240 mL (18 percent) in patients
with 300 eosinophilic cells/microliter or greater (p less than
0.001 for all groups). The companies plan to submit a Supplemental
Biologics License Application (sBLA) to the U.S. Food and Drug
Administration (FDA) by the end of this year.
"Approximately one million U.S. adults and adolescents live with
uncontrolled, persistent asthma, and continue to experience serious
asthma attacks, despite taking an intensive regimen of standard
therapies," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. "Dupilumab has now demonstrated positive
late-stage results in two serious allergic diseases -- asthma and
atopic dermatitis -- with robust efficacy and an extensive safety
database. These results continue to support our hypothesis that the
IL-4/IL-13 pathway is a critical driver of allergic disease, and we
remain committed to further investigating the IL-4/IL-13 pathway in
other allergic diseases."
The results for the 200 mg and 300 mg dupilumab dose groups were
generally comparable on both exacerbations and FEV1. The
extent of patient response correlated with allergic or atopic
status as reflected by blood eosinophils and other markers. Less
activity was observed in patients with less than 150 eosinophilic
cells/microliter. The overall rates of adverse events, deaths,
infections, conjunctivitis, herpes and discontinuations were
comparable between the dupilumab and placebo groups. Injection site
reactions were more common in the dupilumab groups occurring in 17
percent of dupilumab patients compared to 8 percent of placebo
patients.
"We believe that therapies like dupilumab, which focus on
specific molecular pathways such as the Th2 pathway associated with
multiple chronic allergic diseases, are important targets for
further investigations," said Elias
Zerhouni, M.D., President, Global R&D, Sanofi. "The
positive data from this large second pivotal trial in uncontrolled
persistent asthma, following the positive results of dupilumab in
atopic dermatitis, further support this view in our opinion. We
will work diligently with health authorities to bring this new
application of dupilumab to the patients who most need it."
The QUEST pivotal Phase 3 trial enrolled 1,902 patients
including 1,795 adults and 107 adolescents across 413 study sites
worldwide. The four study groups included patients treated with 200
mg every other week with a loading dose of 400 mg, 300 mg every
other week with a loading dose of 600 mg, and two separate placebo
groups. Patients were randomized in a 2:1 fashion to active drug
versus placebo. The two primary endpoints of the study were the
annualized rate of severe exacerbation events at 52 weeks and the
absolute change from baseline in a standard measure of lung
function known as pre-bronchodilator forced expiratory volume over
one second (FEV1) at 12 weeks (changes of 100 to 200 mL
are considered clinically relevant). The pre-specified primary
analysis included hierarchical evaluation of these endpoints in the
overall population, in patients with 150 eosinophilic
cells/microliter or greater, and in patients with 300 eosinophilic
cells/microliter or greater. In the study, approximately 50
percent of patients had 300 eosinophilic cells/microliter or
greater and approximately 70 percent of patients had 150
eosinophilic cells/microliter or greater. Higher eosinophil counts
are generally thought to be associated with poorer asthma control
and higher rates of exacerbations, as was observed in the placebo
patients in this study.
All patients continued on a medium or high dose inhaled
corticosteroid (ICS) and up to two additional controller medicines
throughout the study. Eosinophil subgroups were classified based on
baseline levels.
Detailed results from this study will be submitted for
presentation at a future medical congress. QUEST is the second
pivotal trial in uncontrolled persistent asthma following a
positive Phase 2b pivotal study of dupilumab. Data from another
Phase 3 study known as VENTURE examining the ability of dupilumab
to reduce oral corticosteroid use in patients with severe
steroid-dependent asthma are expected later this year. Also
included in the LIBERTY ASTHMA clinical development program is the
TRAVERSE trial, a long-term safety extension study. The potential
use of dupilumab in asthma is currently under clinical development
and the safety and efficacy have not been fully evaluated by any
regulatory authority.
In March 2017, the FDA approved
DUPIXENT® (dupilumab) in the U.S. for the treatment of
moderate-to-severe atopic dermatitis that is not adequately
controlled with topical prescription therapies.
About Uncontrolled Persistent Asthma
People who live
with uncontrolled persistent asthma often have severe attacks
(exacerbations) that may lead to emergency room visits,
hospitalizations and decreased lung function. Despite currently
available treatments, there is a need for new medicines that offer
comprehensive asthma control including preservation of lung
function and reduction in exacerbations. Uncontrolled persistent
asthma is often associated with other Type 2 allergic inflammatory
diseases including atopic dermatitis, nasal polyps, allergic
rhinitis, eosinophilic esophagitis and food allergies. The disease
is characterized by an imbalance or overactivity of certain immune
cells (including eosinophils) and signaling proteins known as
interleukins. Two of these are Interleukin-4 (IL-4) and
interleukin-13 (IL-13), which are central drivers of Type 2
inflammation.
About Dupilumab Clinical Programs
Dupilumab is a fully
human monoclonal antibody that is designed to simultaneously
inhibit overactive signaling of IL-4 and IL-13 cytokines, one of
the root causes of Type 2 allergic inflammation. Sanofi and
Regeneron are studying dupilumab in a broad range of clinical
development programs for diseases that are driven by Type 2
inflammation, including pediatric atopic dermatitis (Phase 3) nasal
polyps (Phase 3) and eosinophilic esophagitis (Phase 2). These
potential uses are investigational and the safety and efficacy have
not been evaluated by any regulatory authority. Dupilumab 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.
DUPIXENT® (dupilumab) is the first and only biologic
medicine FDA-approved for the treatment of adults with
moderate-to-severe atopic dermatitis (AD) whose disease is not
adequately controlled with topical prescription therapies.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of
the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all
your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- have asthma
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements. If you have asthma and are taking asthma
medicines, do not change or stop your asthma medicine without
talking to your healthcare provider.
DUPIXENT can cause serious side
effects, including:
- Allergic reactions. Stop using DUPIXENT and go to
the nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, joint pain, or skin rash.
- Eye problems. Tell your healthcare provider
if you have any new or worsening eye problems, including eye pain
or changes in vision.
The most common side effects include injection site
reactions, eye and eyelid inflammation, including redness, swelling
and itching, and cold sores in your mouth or on your
lips.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. If your healthcare provider
decides that you or a caregiver can give DUPIXENT injections, you
or your caregiver should receive training on the right way to
prepare and inject DUPIXENT. Do not try to inject
DUPIXENT until you have been shown the right way by your healthcare
provider.
Please click here for the full Prescribing
Information. The patient information is available here.
INDICATION
DUPIXENT is used to treat adult patients with moderate-to-severe
atopic dermatitis (eczema) that is not well controlled with
prescription therapies used on the skin (topical), or who cannot
use topical therapies. DUPIXENT can be used with or without
topical corticosteroids. It is not known if DUPIXENT 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 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 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 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 Dupixent®
(dupilumab) Injection; 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 Dupixent for the treatment of uncontrolled,
persistent asthma in adults and adolescents and other potential
indications; unforeseen safety issues and possible liability
resulting from the administration of products and product
candidates in patients, including without limitation Dupixent;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates (such as Dupixent) in
clinical trials; coverage and reimbursement determinations by
third-party payers, including Medicare, Medicaid, and pharmacy
benefit management companies; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products, research and
clinical programs, and business, including those relating to the
enrollment, completion, and meeting of the relevant endpoints of
post-approval studies; 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 Dupixent;
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 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, 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
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. 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 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 absence of guarantee that
the product will 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 litigation and the
ultimate outcome of such litigation, 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
Regeneron:
|
|
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Media
Relations
|
Investor
Relations
|
|
Ilana
Tabak
|
Manisha
Narasimhan, Ph.D.
|
|
Tel: + 1 (914)
847-3836
|
Tel: +1 (914)
847-5126
|
|
Mobile: +1 (914)
450-6677
|
Manisha.narasimhan@regeneron.com
|
|
ilana.tabak@regeneron.com
|
|
|
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Contacts
Sanofi:
|
|
|
Media
Relations
|
Investor
Relations
|
|
Ashleigh
Koss
|
George
Grofik
|
|
Tel:
908-981-8745
|
Tel: +33 (0) 1 53 77
94 69
|
|
ashleigh.koss@sanofi.com
|
ir@sanofi.com
|
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U.S.
Communications
|
|
|
Carrie
Brown
|
|
|
Tel: +1 (908)
981-6486
|
|
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Mobile: +1 (908)
247-6006
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Carrie.Brown@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.