Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent® (dupilumab) in Moderate-to-Severe Atopic Dermatitis
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term
Pivotal Phase 3 CHRONOS Study of Dupixent(®) (dupilumab) in Moderate-to-Severe
Atopic Dermatitis
- Late-breaking oral abstract to be presented today at the Annual Meeting
of the American Academy of Dermatology -
Paris, France and Tarrytown, N.Y. - March 4, 2017 - Sanofi and Regeneron
Pharmaceuticals, Inc. today presented detailed results from the one-year Phase
3 CHRONOS study, which showed that patients receiving the investigational drug
Dupixent(® )(dupilumab) with topical corticosteroids (TCS) achieved
significantly improved measures of overall disease severity compared to TCS
alone in adults with uncontrolled moderate-to-severe atopic dermatitis (AD). The
data will be presented today as a late-breaking oral abstract at the Annual
Meeting of the American Academy of Dermatology (AAD) taking place in Orlando,
Florida.
"These new results build upon previous positive Phase 3 monotherapy data. In the
CHRONOS study, Dupixent used with topical corticosteroids showed significantly
greater clearance of skin lesions and overall disease severity compared to
topical corticosteroids alone, which are commonly prescribed for moderate-to-
severe atopic dermatitis," said Andrew Blauvelt, M.D., President of Oregon
Medical Research Center and principal investigator of the study. "This study
provides positive long-term data for Dupixent, which is important given atopic
dermatitis is a chronic inflammatory disease. Additionally, the presentation
highlights the critical role of IL-4 and IL-13 as drivers of this atopic
condition."
Patients were eligible for participation in the CHRONOS study if their disease
was uncontrolled by topical medicines including corticosteroids with or without
calcineurin inhibitors. Patients were randomized to receive Dupixent 300 mg
weekly with TCS, Dupixent 300 mg every two weeks with TCS, or placebo with TCS.
Dupixent with TCS significantly improved measures of overall disease severity at
16 and 52 weeks when compared to placebo with TCS.
As previously announced in June 2016, the primary endpoint results at week 16
and secondary endpoint 52-week results were the following:
* At 16 weeks, 39 percent of patients who received either Dupixent 300 mg
weekly with TCS or Dupixent 300 mg every two weeks with TCS achieved clear
or almost clear skin (IGA 0 or 1), compared to 12 percent of patients
receiving placebo with TCS (p less than 0.0001).
* At 16 weeks, 64 percent of patients who received Dupixent 300 mg weekly with
TCS, and 69 percent of patients who received Dupixent 300 mg every two weeks
with TCS achieved EASI-75, a 75 percent reduction on an index measuring
eczema severity, compared to 23 percent of patients receiving placebo with
TCS (p less than 0.0001).
* At 52 weeks, 40 percent of patients who received Dupixent 300 mg weekly with
TCS, and 36 percent of patients who received Dupixent 300 mg every two weeks
with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12.5
percent of patients receiving placebo with TCS (p less than 0.0001).
* At 52 weeks, 64 percent of patients who received Dupixent 300 mg weekly with
TCS, and 65 percent of patients who received Dupixent 300 mg every two weeks
with TCS achieved EASI-75, compared to 22 percent with placebo with TCS (p
less than 0.0001).
New data being presented at the meeting show that:
* At 16 weeks, the mean percent improvement in EASI from baseline was 77
percent for patients who received Dupixent weekly with TCS and for patients
who received Dupixent every two weeks with TCS, compared to 42 percent for
patients receiving placebo with TCS (p less than 0.0001).
* At 16 weeks, the mean percent improvement from baseline in the intensity of
patient-reported itch, as measured by the Pruritus Numerical Rating Scale
(NRS), was 55 percent for patients who received Dupixent weekly with TCS and
58 percent for patients who received Dupixent every two weeks with TCS,
compared to 29 percent for patients receiving placebo with TCS (p less than
0.0001).
* At 16 weeks, 77 percent of patients who received Dupixent weekly with TCS or
Dupixent every two weeks with TCS achieved a >=4-point improvement 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,
compared to 37 percent of patients receiving placebo with TCS (p less than
0.0001).
* At 16 weeks, 74 percent of patients who received Dupixent weekly with TCS
and 81 percent of patients who received Dupixent every two weeks with TCS
achieved a >=4-point improvement in aspects of their quality of life, as
measured by the Dermatology Life Quality Index (DLQI), compared to 43
percent of patients receiving placebo with TCS (p less than 0.0001).
Dermatology life Quality Index (DLQI) is a ten-question questionnaire used
to measure the impact of skin disease on the quality of life of an affected
person.
* At 52 weeks, the mean percent improvement in EASI from baseline was 80
percent for patients who received DUPIXENT weekly with TCS and 78 percent
for patients who received DUPIXENT every two weeks with TCS, compared to 46
percent for patients receiving placebo with TCS (p less than 0.0001).
* At 52 weeks, the mean percent improvement from baseline in the intensity of
patient-reported itch, as measured by the NRS, was 54 percent for patients
who received DUPIXENT weekly with TCS and 56 percent for patients who
received DUPIXENT every two weeks with TCS, compared to 27 percent for
patients receiving placebo with TCS (p less than 0.0001).
* At 52 weeks, 64 percent of patients who received Dupixent weekly with TCS
and 76 percent of patients who received Dupixent every two weeks with TCS
achieved a >=4-point improvement in the severity of their AD, as measured by
POEM, compared to 26 percent of patients receiving placebo with TCS (p less
than 0.0001).
* At 52 weeks, 63 percent of patients who received Dupixent weekly with TCS
and 80 percent of patients who received Dupixent every two weeks with TCS
achieved a >=4-point improvement their quality of life, as measured by the
DLQI, compared to 30 percent of patients receiving placebo with TCS (p less
than 0.0001).
In the CHRONOS trial, 85 percent of patients who received Dupixent weekly with
TCS and 86 percent of patients who received Dupixent every two weeks with TCS
completed the 52 week treatment, compared to 67 percent of patients in the
placebo group. Patients who received Dupixent with TCS had higher rates of
injection site reactions (19 percent Dupixent weekly, 15 percent Dupixent every
two weeks and 8 percent TCS alone) and cases of conjunctivitis (19percent
Dupixent weekly,14 percent Dupixent every two weeks and 8 percent TCS alone).
The Dupixent Biologics License Application (BLA) was accepted for Priority
Review by the U.S. Food and Drug Administration (FDA) with a target action date
of March 29, 2017. The FDA granted Dupixent Breakthrough Therapy designation in
uncontrolled moderate-to-severe AD in 2014. The European Medicines Agency (EMA)
accepted for review the Marketing Authorization Application (MAA) on December
8, 2016.The European Medicines Agency (EMA) and FDA have conditionally accepted
Dupixent as the trade name for dupilumab.
Dupixent is currently under clinical development and its safety and efficacy
have not been fully evaluated by any regulatory authority. If approved, Dupixent
would be commercialized by Regeneron and Sanofi Genzyme, the specialty care
global business unit of Sanofi.
About Atopic Dermatitis
AD is the most common form of eczema and is characterized by unpredictable
flare-ups. It is a chronic inflammatory disease with symptoms often appearing on
the skin. Moderate-to-severe AD is characterized by rashes and can include
intense, persistent and debilitating itching, skin dryness, cracking, redness,
crusting, and oozing. Itch is one of the most burdensome symptoms for patients
and can be debilitating.
It's estimated approximately 300,000 people in the United States are living with
uncontrolled moderate-to-severe AD and despite their current treatment, are most
in need of new treatment options. Despite currently available therapies, there
still remains an unmet need for treatments that help those adults struggling to
manage their moderate-to-severe AD.
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 science-based biopharmaceutical company
that discovers, invents, develops, manufactures and commercializes medicines for
the treatment of serious medical conditions. Regeneron commercializes medicines
for eye diseases, high LDL cholesterol and a rare inflammatory condition and has
product candidates in development in other areas of high unmet medical need,
including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and
infectious diseases. 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 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
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, 2015. 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); 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
(including possible regulatory approval of Dupixent by the U.S. Food and Drug
Administration and the European Medicines Agency) 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).
Contacts Sanofi:
Media Relations Investor Relations
Ashleigh Koss George Grofik
Tel: 1 (908) 981-8745 Tel: +33 (0) 1 53 77 45 45
ashleigh.koss(at)sanofi.com IR(at)sanofi.com
Contacts Regeneron:
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(at)regeneron.com
ilana.tabak(at)regeneron.com
Press release (PDF):
http://hugin.info/152918/R/2084953/786095.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
Unternehmensinformation / Kurzprofil:
Datum: 04.03.2017 - 16:30 Uhr
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