TARRYTOWN, N.Y. and
PARIS, Oct.
1, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announce that detailed
results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled
Phase 3 studies evaluating investigational Dupixent®
(dupilumab) in adult patients with inadequately controlled
moderate-to-severe atopic dermatitis (AD), were published in the
New England Journal of Medicine (NEJM). The studies met
their primary endpoints evaluating the extent and severity of the
disease. In addition, both trials met key secondary endpoints
measuring reduction in itch, improvement in patient-reported
anxiety and depression symptoms, and certain quality of life
measures. Dupixent inhibits signaling of IL-4 and IL-13, two key
cytokines required for the type 2 (including Th2) immune response,
which is believed to be a major driver in AD, and certain atopic or
allergic diseases including asthma and nasal polyposis, where
Dupixent is being evaluated in ongoing clinical studies.
"These results support the growing body of evidence for
Dupixent as a potential new treatment option for patients with
moderate-to-severe atopic dermatitis who are struggling to control
their disease. The Phase 3 SOLO 1 and SOLO 2 clinical trials are
the first large pivotal studies where a systemic investigational
therapy has demonstrated a significant reduction in the signs
and symptoms of atopic dermatitis, and showed improvement in
studied quality of life measures," said Eric Simpson, M.D., M.C.R., Oregon Health &
Science University, and lead author of the NEJM paper.
"Additionally, the reduction of itch intensity is important because
itching is one of the most burdensome symptoms for patients and can
impact other aspects of their lives, such as sleep."
The NEJM paper provides data on key endpoints including:
- At 16 weeks for SOLO 1 and SOLO 2, respectively, 37 and 36
percent of adult patients who received Dupixent 300 mg weekly, and
38 and 36 percent of patients who received Dupixent 300 mg every
two weeks, achieved clearing or near-clearing of skin lesions as
measured by the 5-point Investigator's Global Assessment (IGA)
scale, compared to 10 and 8 percent with placebo (p less than
0.001). This was the primary endpoint of the study in the U.S. and
one of the primary endpoints in the EU.
- At 16 weeks for SOLO 1 and SOLO 2, respectively, 52 and 48
percent of adult patients who received Dupixent 300 mg weekly, and
51 and 44 percent of patients who received Dupixent 300 mg every
two weeks, achieved a 75 percent or greater reduction in their
Eczema Area and Severity Index score (EASI-75) compared to 15 and
12 percent with placebo (p less than 0.001). This was the key
secondary endpoint in the U.S. and one of the primary endpoints in
the EU.
- At 16 weeks for SOLO 1 and SOLO 2, respectively, the percent
improvement in EASI from baseline was 72 and 69 percent in patients
who received the 300 mg weekly dose, and 72 and 67 percent for
patients who received Dupixent 300 mg every two weeks, compared to
38 and 31 percent for placebo (p less than 0.001).
- The reduction in the daily intensity of patient-reported itch,
as measured by the Pruritus Numerical Rating Scale (NRS), was a
secondary endpoint that was met at 2 weeks, 4 weeks and 16 weeks.
The Pruritus NRS ranges from 0 (no itch) to 10 (worst itch
imaginable). At 16 weeks, for SOLO 1 and SOLO 2, respectively, 40
and 39 percent of patients who received Dupixent 300 mg weekly and
41 and 36 percent of patients who received Dupixent 300 mg every
two weeks achieved a four-point or greater reduction in their NRS
score compared to 12 and 10 percent with placebo (p less than
0.001).
Other positive secondary endpoints discussed in the NEJM paper
include improvement in patient-reported anxiety and depression
symptoms and certain quality of life measures as evaluated by
Scoring Atopic Dermatitis (SCORAD), Hospital Anxiety and Depression
Scale (HADS), Patient-Oriented Eczema Measure (POEM), and
Dermatology Life Quality Index (DLQI).
For the 16-week treatment period, the overall rate of adverse
events (65-73 percent Dupixent and 65-72 percent placebo) was
comparable between the Dupixent groups and the placebo groups. The
proportion of patients who completed the treatment period was 88-94
percent for Dupixent and 80.5-82 percent for placebo. The rate of
serious adverse events was 1-3 percent for Dupixent and 5-6 percent
for placebo. Serious or severe infections were similar in the
Dupixent and placebo groups in both studies (1 percent Dupixent and
1 percent placebo). Adverse events that were noted to have a higher
rate with Dupixent treatment across both studies included injection
site reactions (8-19 percent Dupixent; 6 percent placebo) and
conjunctivitis (1-5 percent Dupixent; 1 percent placebo). No
patients discontinued therapy due to injection site reactions and
one patient discontinued therapy due to conjunctivitis.
The Dupixent Biologics License Application (BLA) was recently
accepted for Priority Review by the U.S. Food and Drug
Administration (FDA) with a Prescription Drug User Fee Act (PDUFA)
target action date of March 29, 2017.
The FDA granted Dupixent Breakthrough Therapy designation in
uncontrolled moderate-to-severe atopic dermatitis in 2014. 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. In addition to AD, Dupixent is being evaluated in
asthma, nasal polyposis and eosinophilic esophagitis. If approved,
Dupixent would be commercialized by Regeneron and Sanofi Genzyme,
the specialty care global business unit of Sanofi.
Regeneron and Sanofi will host an Investor Relations Thematic
Conference Call for the financial community focusing on Dupixent
following the late breaking data presentation at EADV at the
following time: 7:00 a.m. ET
(New York), 12:00 p.m. BST (London), 1:00 p.m.
CEST (Paris and
Vienna). To access this
call, dial (888) 771-4371 (U.S.), 0805 102 604 (France), or 0808 238 9578 (UK). The
conference call will include a presentation followed by a Q&A
session and will be accessible through an audio webcast at
www.regeneron.com. A replay of the conference call and webcast will
be archived on the Company's website.
About the LIBERTY AD SOLO 1 and SOLO 2 TRIALS
The Liberty AD Phase 3 clinical program consists of five trials
of patients with moderate-to-severe atopic dermatitis (AD) at sites
worldwide. A total of 1,379 adult patients with moderate-to-severe
AD were enrolled in the identically designed SOLO 1 and SOLO 2
trials. Patients were enrolled if they were not adequately
controlled with topical medications, or if topical treatment was
not medically advisable. All patients were assessed via the 5-point
Investigator's Global Assessment (IGA) scale, ranging from 0
(clear) to 4 (severe); entry criteria required a baseline score of
3 or 4. Patients were also assessed using the Eczema Area and
Severity Index (EASI) and other measures. Patients were randomized
into one of three treatment groups: Dupixent 300 mg subcutaneously
once per week, Dupixent 300 mg subcutaneously every two weeks, or
placebo for 16 weeks following an initial Dupixent loading dose of
600 mg subcutaneously, or placebo.
About Moderate-to-Severe Atopic Dermatitis
Moderate-to-severe atopic dermatitis, a serious, chronic form of
eczema, is characterized by rashes and can include intense itching,
skin dryness, cracking, redness, crusting, and oozing. Even though
atopic dermatitis symptoms appear on the skin, they are fueled by a
continuous cycle of underlying inflammation triggered in part by a
malfunction in the immune system. People living with the physical
symptoms of atopic dermatitis may also feel self-conscious and
embarrassed about their appearance and may experience anxiety,
depression, and feelings of social isolation.
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 Merial. 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 based in Tarrytown, New York 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, asthma, atopic dermatitis, pain, oncology, and
infectious diseases. For additional information about the company,
please visit www.regeneron.com or follow @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 adult patients with inadequately
controlled moderate-to-severe atopic dermatitis 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 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 and Bayer HealthCare LLC (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. 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, 2015 and its
Form 10-Q for the quarterly period ended June 30, 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
|
Jack
Cox
|
George
Grofik
|
Tel: +33 (0) 1 53 77
94 74
|
Tel: +33 (0) 1 53 77
94 69
|
jack.cox@sanofi.com
|
ir@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@regeneron.com
|
ilana.tabak@regeneron.com
|
|
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SOURCE Regeneron Pharmaceuticals, Inc.