Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an IL-4R alpha Antibody, in Atopic Dermatitis

Sat Mar 2, 2013 9:00am EST

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Phase 1b Data Presented at Late Breaking Session of 71st Annual Meeting of the
American Academy of Dermatology
PARIS  and  TARRYTOWN, N.Y.,  March 2, 2013  /PRNewswire/ -- Sanofi (EURONEXT:
SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that pooled data from two Phase 1b trials with dupilumab
(REGN668/SAR231893), an investigational, high-affinity, subcutaneously
administered, fully-human antibody targeting the alpha subunit of the
interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting
of the American Academy of Dermatology (AAD) in  Miami.

The primary objective of the Phase 1b studies was to assess the safety profile
of dupilumab.  Other exploratory endpoints included pharmacokinetic, biomarker,
and efficacy parameters.  The efficacy data showed that treatment with four
weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or
300mg per week, significantly improved the signs and symptoms of patients with
moderate-to-severe atopic dermatitis (AD) whose disease was not adequately
controlled with topical medications.  Specifically, patients treated with
dupilumab had significant improvements in body surface area (BSA) score,
Investigator Global Assessment (IGA) score, and Eczema Area Severity Index
(EASI) from baseline to week 4 compared to placebo (p<0.05 vs. placebo for all
measures and doses).  The significant improvements in BSA, IGA, and EASI scores
were maintained at week 8 in the 300mg dose group (p<0.05 vs. placebo).  A
responder analysis demonstrated that at week 4, 54.5% of patients treated with
the 150mg dose and 71.4% of patients treated with the 300mg dose achieved a
reduction in EASI score of 50% or greater compared to 18.8% with placebo
(p<0.05).  The most common adverse events (AEs) were nasopharyngitis (19.6% vs
12.5% for placebo) and headache (11.8% vs 6.3% for placebo).

"Despite existing therapies, a significant proportion of patients with
moderate-to-severe atopic dermatitis continue to suffer from inflamed skin and
intractable itch, which significantly impacts their quality of life," said Dr. 
Eric Simpson, Associate Professor, Director of Clinical Studies, Oregon Health
and Science University,  Portland, Oregon, USA, and Principal Investigator of
the study.  "The early phase results with this biologic therapy, which has a
novel mechanism of action, are encouraging to those of us who treat these
patients and warrant further clinical investigation."

"Through blockade of IL-4R alpha, dupilumab modulates signaling of both the IL-4
and IL-13 pathway, which have been implicated in the pathophysiology of allergic
disease," said  George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories.  "We look forward to
presenting additional data from a 12-week, Phase 2a trial in atopic dermatitis,
as well as starting a larger Phase 2b trial with dupilumab in patients with
atopic dermatitis, later this year."

Presented today in a late-breaking clinical trials session at the AAD meeting,
the Phase 1b trials included 67 patients randomized to three different doses of
dupilumab (75mg, n=8; 150mg, n=22; 300mg, n=21) and placebo (n=16).  The primary
objective of the Phase 1b studies was to assess the safety profile of dupilumab.
 Other endpoints included pharmacokinetic, biomarker, and efficacy parameters. 
Following the 4-week treatment period, patients in the studies were followed for
an additional 4 weeks for a total of 8 weeks.  

About IL-4R and the IL-4/IL-13 Pathway
Atopic dermatitis and some types of asthma are characterized by the induction of
a specific type of an immune response that is driven by a subset of immune cells
called Type 2 helper T cells, or Th2 cells.  IL-4 and IL-13 are key cytokines
that are required for the initiation and maintenance of this Th2 immune
response.  Both IL-4 and IL-13 signaling occurs through two different IL-4
receptors (Type I and II), which both contain a common IL-4R alpha subunit.

About Dupilumab (SAR231893/REGN668)
Dupilumab is a fully human monoclonal antibody directed against IL-4R alpha and
is administered via subcutaneous injection.  By blocking IL-4R alpha dupilumab
modulates signaling of both IL-4 and IL-13, drivers of a Th2 immune response. 
Dupilumab was created using Regeneron's pioneering  VelocImmune technology and
is being co-developed with Sanofi.  Dupilumab is currently being studied in both
atopic dermatitis and asthma.

About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic, immune-mediated, inflammation of the skin
that is characterized by poorly defined erythema (redness) with edema
(swelling), weeping in the acute stage, and skin thickening (lichenification) in
the chronic stage.  Chronic and/or relapsing lesions, along with pruritus
(itching) and scratching are the hallmarks of the disease.  The prevalence of AD
is estimated to be between 1% and 3% of adults.  For many patients, topical
therapies are not effective for keeping the disease under control and the only
approved systemic therapies to treat AD are prednisone and cyclosporine (in 
Europe).  Moderate-to-severe atopic dermatitis can negatively impact patients'
lives and is associated with a high burden to society both in terms of direct
costs of medical care and prescription drugs, as well as loss of productivity.

About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme.  Sanofi is listed in  Paris 
(EURONEXT: SAN) and in  New York  (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.
Regeneron 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 markets medicines for eye diseases, colorectal cancer, and a rare
inflammatory condition and has product candidates in development in other areas
of high unmet medical need, including hypercholesterolemia, rheumatoid
arthritis, asthma, and atopic dermatitis.  For additional information about the
company, please visit  www.regeneron.com.

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
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"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
labeling 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, the Group's ability to benefit
from external growth opportunities, trends in exchange rates and prevailing
interest rates, the impact of cost containment policies 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, 2011.  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
This news release includes forward-looking statements that involve risks and
uncertainties relating to future events and the future performance of Regeneron,
and actual events or results may differ materially from these forward-looking
statements.  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
Dupilimab; unforeseen safety issues resulting from the administration of
products and product candidates in patients; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's late-stage
product candidates; 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 of Regeneron's products and
product candidates; the ability of Regeneron to manufacture and manage supply
chains for multiple 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 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, to
be canceled or terminated without any further product success; and risks
associated with third party intellectual property 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, 2012.  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, unless required by law.

 Contacts:                                                         
                                                                   
 Sanofi:                                                           
                                                                   
 Media Relations                    Investor Relations             
 Marisol Peron                      Sebastien Martel               
 Tel: +33 (0) 1 53 77 45 02         Tel: +33 (0)1 53 77 45 45      
 Mobile: +33 (0) 6 08 18 94 78      E-mail:  IR@sanofi.com         
 E-mail:  marisol.peron@sanofi.com                                 
                                                                   
 Regeneron:                                                        
                                                                   
 Media Relations                    Investor Relations             
 Peter Dworkin                      Michael Aberman, M.D.          
 Tel: 1 (914) 847-7640              Tel: 1 (914) 847-7799          
 peter.dworkin@regeneron.com        michael.aberman@regeneron.com  


SOURCE  Regeneron Pharmaceuticals, Inc.

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