Sanofi and Regeneron Announce Positive Study Results for Dupixent® (dupilumab) in Patients With Moderate-to-Severe Atopic Dermatitis
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Positive Study Results for Dupixent(®) (dupilumab)
in Patients With Moderate-to-Severe Atopic Dermatitis
- Late-breaking oral abstract of Phase 3 CAFÉ study presented at the
26th European Academy of Dermatology and Venereology (EADV) Congress -
Paris, France and Tarrytown, N.Y. - September 16, 2017 - Sanofi and Regeneron
Pharmaceuticals, Inc. announced today positive results from the Phase 3 CAFÉ
study of Dupixent(®) (dupilumab) in adults with moderate-to-severe atopic
dermatitis (AD) who are inadequately controlled with or intolerant to the broad
immunosuppressant drug cyclosporine A (CSA), or when this treatment is medically
inadvisable.[1] In the study, Dupixent with topical corticosteroids (TCS)
significantly improved measures of overall disease severity, skin clearing,
itching, and patient reported quality of life measures. CSA is approved for the
treatment of AD in most European countries and Japan; it is not approved in the
U.S. for this use. The results of this study are being presented at the
European Academy of Dermatology and Venerology (EADV) Congress in Geneva,
Switzerland.
The primary endpoint of the study was the proportion of patients that achieved a
75 percent or greater improvement in the Eczema Area and Severity Index (EASI-
75) score at 16 weeks from baseline. EASI is a tool used to measure the extent
and severity of the disease. Fifty-nine percent of patients who received
Dupixent weekly with TCS, and 63 percent of patients who received Dupixent every
two weeks with TCS achieved EASI-75, compared to 30 percent of those patients
who received placebo with TCS (p less than 0.0001).
The mean percent change improvement in EASI from baseline at 16 weeks (a
secondary endpoint) was 78 percent and 80 percent for patients who received
Dupixent weekly or every two weeks with TCS, respectively, compared to 47
percent for those who received placebo plus TCS (p less than 0.0001).
"In moderate-to-severe atopic dermatitis, some patients stop cyclosporine
therapy due to intolerance or lack of efficacy, or are not candidates because of
other medical conditions or contraindicated medications," said Dr. Marjolein De
Bruin-Weller, Dermatologist, National Expertise Center for Atopic Dermatitis,
University Medical Center Utrecht. "In the CAFÉ study, Dupixent with topical
corticosteroids significantly improved overall measures of disease severity
including lesions, itch, quality of life measures and symptoms of anxiety and
depression in these patients. The safety profile in this study was consistent
with three previous positive Dupixent Phase 3 studies in moderate-to-severe
atopic dermatitis."
Other secondary endpoints of the study included measures of the impact of
Dupixent on the persistent itch caused by the disease, quality of life measures,
and symptoms of anxiety and depression. The results for these secondary
endpoints at 16 weeks include:
* The mean percent improvement from baseline in the intensity of patient-
reported itch, as measured by the pruritus Numerical Rating Scale (NRS), was
52 percent and 54 percent in patients who received Dupixent weekly or every
two weeks with TCS, respectively, compared to 25 percent for those who
received placebo plus TCS (p less than 0.0001).
* The proportion of patients with a greater than or equal to four-point
improvement from baseline in aspects of patient quality of life, as measured
by the Dermatology Life Quality Index (DLQI), was 78 percent and 88 percent
in patients who received Dupixent weekly or every two weeks with TCS,
respectively, compared to 44 percent of those who received placebo plus TCS
(p less than 0.0001).
* The proportion of patients with a greater than or equal to four-point
improvement from baseline in the severity of their AD, as measured by the
Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness
as experienced by the patients, was 76 percent and 83 percent in patients
who received Dupixent weekly or every two weeks with TCS, respectively,
compared to 42 percent for those who received placebo plus TCS (p less than
0.0001).
No new adverse events were reported in the study. The proportion of patients
reporting an adverse event was similar among the treatment arms. Conjunctivitis
was more frequent in patients who received Dupixent with TCS, with 16 percent
and 28 percent reported in patients who received Dupixent weekly or every two
weeks with TCS, respectively, compared to 11 percent for patients who received
placebo with TCS. Injection site reactions were reported in 11 percent and 4
percent among patients who received DUPIXENT with TCS weekly or every two weeks,
respectively, compared to 5 percent for patients who received placebo with TCS.
Skin infections were reported in 4 percent and 2 percent among patients who
received Dupixent weekly or every two weeks with TCS, respectively, compared to
8 percent for patients who received placebo with TCS.
A total of 325 patients in Europe were randomized into three treatment groups in
the 16-week study to receive either Dupixent 300 mg weekly with TCS, Dupixent
300 mg every two weeks with TCS or placebo with TCS.
About Dupixent (dupilumab)
Dupixent is a human monoclonal antibody that is designed to simultaneously
inhibit overactive signaling of IL-4 and IL-13 cytokines.[2](,)[3] In addition
to moderate-to-severe atopic dermatitis, Sanofi and Regeneron are studying
dupilumab in a broad range of clinical development programs including
uncontrolled persistent asthma (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 is being jointly developed by Sanofi and Regeneron under a global
collaboration agreement.
In March 2017, the U.S. Food and Drug Administration (FDA) approved Dupixent(®)
(dupilumab) in the U.S. for the treatment of adults with moderate-to-severe
atopic dermatitis whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not advisable.[4] Dupixent
is given as one, 300 mg injection under the skin (subcutaneous injection) every
2 weeks after an initial loading dose (600 mg). The European Commission (EC) is
expected to adopt a final decision on the Marketing Authorization Application
(MAA) for Dupixent in the European Union, following the Committee for Medicinal
Products for Human Use (CHMP) adopting a positive opinion on July 21, 2017.
About Atopic Dermatitis
Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with
symptoms often appearing as a rash on the skin.[5](,)[6](,)[7](,)[8] Moderate-
to-severe atopic dermatitis is characterized by rashes often covering much of
the body, and can include intense, persistent itching and skin dryness,
cracking, redness, crusting, and oozing.[9] Itch is one of the most burdensome
symptoms for patients and can be debilitating.[10] In addition, patients with
moderate-to-severe atopic dermatitis experience a substantial burden of disease,
including skin lesions, intense pruritus, and impact on quality of life
components, such as sleep and symptoms of anxiety and depression.[10](,)[11]
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.
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 repeatedly and
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, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug development process
through its unique VelociSuite(®) technologies 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 (at)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 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 future 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.
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 moderate-to-severe atopic dermatitis in the
European Union and other potential jurisdictions, as well as 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 later
studies and lead to therapeutic applications; 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 and its Form 10-Q
for the quarterly period ended June 30, 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).
Contacts Sanofi:
Investor Relations
Media Relations George Grofik
Ashleigh Koss Tel. +33 (0)1 53 77 45 45
Tel: +1 908 981 8745 ir(at)sanofi.com
ashleigh.koss(at)sanofi.com
Contacts Regeneron:
Media Relations
Ilana Tabak Investor Relations
Tel: 1 (914) 847-3836 Manisha Narasimhan, Ph.D.
Mobile: +1 (914) 450-6677 Tel: 1 (914) 847-5126
ilana.tabak(at)regeneron.com Manisha.narasimhan(at)regeneron.com
--------------------------------------------------------------------------------
[1] de Bruin-Weller et al. Dupilumab in adult patients with atopic dermatitis
and history of inadequate response, intolerance to, or medically inadvisable for
cyclosporine A: a placebo-controlled, randomized phase 3 clinical trial (Liberty
AD CAFÉ), EADV 2017, Geneva, Switzerland, September 13-17, 2017.
[2] Dupixent Summary of Product Characteristics.
[3] Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic
Dermatitis. NEJM, vol. 375, pp. 2335-2348, 2016.
[4] Dupixent Prescribing Information 2017.
https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf. Accessed August
2017.
[5] Eichenfield et al. Guidelines of Care for Atopic Dermatitis. AAD 2014, pp.
118.
[6] Guideline to treatment, European Dermatology Forum.
http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-
miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-
dermatitis. Accessed December 23, 2016.
[7] Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the
outside. Page 19.
[8] National Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A
type of eczema) 2013.
http://www.niams.nih.gov/Health_Info/Atopic_Dermatitis/default.asp. Accessed
October 31, 2016.
[9] Mount Sinai. Patient Care Atopic Dermatitis. Available at:
http://www.mountsinai.org/patient-care/health-library/diseases-and-
conditions/atopic-dermatitis#risk. Accessed August 2017.
[10] Zuberbier T et al. Patient perspectives on the management of atopic
dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232, 2006.
[11] Torrelo A et al. Atopic dermatitis: impact on quality of life and patients'
attitudes toward its management. Eur J Dermatol vol. 22(1), pp. 97-105, 2012.
Press release (PDF):
http://hugin.info/152918/R/2134514/816619.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
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Datum: 16.09.2017 - 08:15 Uhr
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