Regeneron and Sanofi Announce Positive Results from Phase 2b Study of Dupilumab in Patients with Moderate-to-Severe Atopic Derm

    Regeneron and Sanofi Announce Positive Results from Phase 2b Study of
       Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis

Results from Earlier Clinical Trials Published Today in the New England
Journal of Medicine

PR Newswire

TARRYTOWN, N.Y. and PARIS, July 9, 2014

TARRYTOWN, N.Y. and PARIS, July 9, 2014 /PRNewswire/ --Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SANand NYSE: SNY)
today announced positive results from a Phase 2b dose-ranging study of
dupilumab, an investigational therapy, in adult patients with
moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema.
All doses of dupilumab met the primary endpoint of a greater improvement in
Eczema Area and Severity Index (EASI) scores from baseline compared to
placebo. In addition, the companies also announced that four earlier clinical
studies of dupilumab in moderate-to-severe atopic dermatitis were published
today in the New England Journal of Medicine (NEJM). Dupilumab is an
investigational monoclonal antibody that blocks signaling of IL-4 and IL-13,
two cytokines that play a key role in the pathogenesis of moderate-to-severe
atopic dermatitis.

"These clinical data, coupled with our phase 2a results in asthma last year,
support the growing scientific evidence that the IL-4/IL-13 pathway may be a
fundamental driver in allergic diseases," said George D. Yancopoulos, M.D.,
Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron
Laboratories. "Blocking IL-4/IL-13 signaling may provide an important new
approach to atopic conditions, including asthma, atopic dermatitis and nasal
polyposis, where we have ongoing clinical programs."

In the Phase 2b trial, all five subcutaneous doses of dupilumab showed a
dose-dependent improvement in the primary endpoint, the mean percent change in
EASI score from baseline to week 16. The improvements in EASI score ranged
from a high of 74 percent for patients in the highest dose group, who received
300 milligrams (mg) weekly, to a low of 45 percent in patients who received
the lowest dose of 100 mg monthly, compared to 18 percent for patients in the
placebo group (p<0.0001 for all doses).

The most common adverse event (AE) in the Phase 2b study was nasopharyngitis,
which was balanced across dupilumab treatment groups (18.5 to 23 percent)
compared to placebo (21 percent). Injection site reactions were more frequent
in the dupilumab group (5 to 9.5 percent) compared to placebo (3 percent), as
was headache (12 to 15 percent) compared to placebo (8 percent).

Dupilumab-treated patients showed highly statistically significant and
dose-dependent improvements in additional key efficacy measures compared to
placebo after 16 weeks of treatment:

  o12 percent to 33 percent of dupilumab-treated patients achieved clearing
    or near-clearingof skin lesions, as measured by an investigator's global
    assessment (IGA) score of 0 or 1,compared to 2 percent with placebo.
    (p=0.02 to p<0.0001)
  oDupilumab-treated patients experienced a 16.5 percent to 47 percent mean
    reduction initching, as measured by the pruritus numerical-rating scale
    (NRS) score, compared to an increase of 5 percent in the placebo group.
    (p=0.0005 to p<0.0001)

"Atopic dermatitis is known to have a profoundly negative effect on quality of
life and people with more severe forms of this disease have limited
therapeutic choices," said Elias Zerhouni, M.D., President, Global R&D,
Sanofi. "These latest results are consistent with what was observed in the
earlier clinical studies and add to the body of evidence that investigational
dupilumab may have a role to play for patients with moderate-to-severe atopic
dermatitis. We are now able to select the optimal doses for the phase 3
studies, which we anticipate to begin later this year."

This Phase 2b double-blind, placebo-controlled, 16-week, dose-ranging study
randomized 380 patients with moderate-to-severe atopic dermatitis, who could
not be adequately controlled with topical medication or for whom topical
treatment was not advisable. Patients were randomized to receive one of five
doses of dupilumab (300 mg weekly, 300 mg every other week, 300 mg monthly,
200 mg every other week, 100 mg monthly) or placebo. Patients in the study
had approximately 50 percent of their skin affected by atopic dermatitis at
baseline. Within the past year, approximately 35 percent of patients received
an oral corticosteroid and approximately 20 percent received a systemic
non-steroid immunosuppressant for AD. Approximately 60 percent of patients
had another allergic condition, including approximately 40 percent of patients
who had a history of asthma. The follow-up period of the study is ongoing and
patients will be followed for 16 weeks after treatment.

The NEJM Dupilumab Moderate-to-Severe Atopic Dermatitis Publication
The New England Journal of Medicine publication includes data from four
placebo-controlled studies, which all evaluated weekly subcutaneous doses of
dupilumab. This included a Phase 2a 12-week monotherapy study, a Phase 2a,
four-week study of dupilumab in combination with topical glucocorticoids and
two Phase 1 four-week monotherapy studies. In these studies, the most common
AEs were nasopharyngitis and headache, which occurred with a higher frequency
in the dupilumab group. Treatment with dupilumab, either as a monotherapy or
in combination, was associated with improvement in skin lesions and
substantial improvements in pruritus (itching). The full publication is
available at www.nejm.org.

"The New England Journal of Medicine publication brings important attention to
moderate-to-severe atopic dermatitis, a common, chronic skin condition
characterized by severe itching that can have a significant negative impact on
a patient's ability to lead a full and active life," said Lisa Beck, M.D.,
Department of Dermatology, University of Rochester Medical Center and lead
author of the NEJM paper. "We are encouraged by the consistent findings across
these earlier studies and look forward to further clinical investigation with
dupilumab."

About the IL-4/IL-13 Pathway and Atopic Dermatitis
Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is a
systemic inflammatory disease characterized by an allergic response 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. Moderate-to-severe forms of atopic dermatitis
can be characterized by pronounced cutaneous dryness, and skin lesions marked
by redness, infiltration/papulation, crusting/oozing, and lichenification
(skin thickening), with periods of lesion exacerbation accompanied by intense
itching, scratching, and skin damage that can lead to secondary infections.
Moderate-to-severe atopic dermatitis can negatively impact patients' lives
and is associated with a high burden to society in terms of direct costs of
medical care and prescription drugs and loss of productivity.

About Dupilumab
Dupilumab, a fully-human monoclonal antibody, is directed against the shared
IL-4R alpha subunit, which blocks signaling from both IL-4 and IL-13.
Dupilumab was created using Regeneron's pioneering VelocImmune® technology
and is being co-developed with Sanofi in atopic dermatitis, asthma and nasal
polyposis. Dupilumab is an investigational agent under clinical development
and its safety and efficacy have not been fully evaluated by any regulatory
authority.

About Sanofi
Sanofi, a global 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 commercializes 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, oncology,
rheumatoid arthritis, asthma, and atopic dermatitis. For additional
information about the company, please visit www.regeneron.com.

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This press release contains forward-looking statements as defined in the
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well as those discussed or identified in the public filings with the SEC and
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report on Form 20-F for the year ended December 31, 2013. Other than as
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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. Words such as "anticipate," "expect," "intend,"
"plan," "believe," "seek," "estimate," variations of such words, and similar
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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 dupilumab; unforeseen
safety issues resulting from the administration of products and product
candidates in patients, including serious complications or side effects in
connection with the use of Regeneron's product candidates in clinical trials,
such as the contemplated Phase 3 study of dupilumab in patients with
moderate-to-severe atopic dermatitis; the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage product
candidates, including without limitation dupilumab for the treatment of atopic
dermatitis; ongoing regulatory obligations and oversight impacting Regeneron's
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competing drugs and product candidates that may be superior to Regeneron's
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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, 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, 2013 and its Form 10-Q
for the quarter ended March 31, 2014. 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.

Sanofi Contacts:
Media Relations                 Investor Relations
Jack Cox                        Sebastien Martel
Tel:+33 (0)1 53 77 94 74        Tel.: +33 (0)1 53 77 45 45
jack.cox@sanofi.com          ir@sanofi.com
Regeneron Contacts:
Media Relations                 Investor Relations
Hala Mirza                      Manisha Narasimhan, Ph.D.
Tel: 1 (914) 847-3422           Tel: 1 (914) 847-5126
hala.mirza@regeneron.com   manisha.narasimhan@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.

Website: http://www.regeneron.com
 
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