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

PR Newswire/Les Echos/ 
 Sanofi and Regeneron Report Positive Proof-of-Concept Data for Dupilumab, an 
                IL-4R alpha Antibody, in Atopic Dermatitis 
- Phase 1b Data Presented at Late Breaking Session of 71st Annual Meeting of the 
                     American Academy of Dermatology - 
Paris, France and Tarrytown, NY - March 2, 2013 - 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 the IL-4alpha receptor, 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-4Ralpha 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(r) technology and
is being co-developed with Sanofi. Dupilumab is currently being studied in both
atopic dermatitis and asthma as a subcutaneous injection. 
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 
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Sanofi Media Relations                  Sanofi Investor Relations
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Regeneron Media Relations               Regeneron Investor Relations
Peter Dworkin                           Michael Aberman, M.D.
Tel: 1 (914) 847-7640                   Tel: 1 (914) 847-7799    
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-0- Mar/04/2013 07:37 GMT
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