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Sanofi and Regeneron Report Positive Results with Sarilumab in First Phase 3 Rheumatoid Arthritis Registration Trial

 Sanofi and Regeneron Report Positive Results with Sarilumab in First Phase 3
                   Rheumatoid Arthritis Registration Trial

Sarilumab, Given Subcutaneously Every Other Week, Met All Three Co-Primary
Endpoints

Sarilumab is the First Fully-Human Monoclonal Antibody Directed Against the
Interleukin-6 Receptor (IL-6R)

PR Newswire

PARIS and TARRYTOWN, N.Y., Nov. 22, 2013

PARIS and TARRYTOWN, N.Y., Nov. 22, 2013 /PRNewswire/ --Sanofi (EURONEXT:
SANand NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that in the SARIL-RA-MOBILITY Phase 3 clinical trial in adult
patients with active rheumatoid arthritis (RA) who were inadequate responders
to methotrexate (MTX) therapy, sarilumab (the first fully-human anti-IL-6R
monoclonal antibody) treatment in combination with MTX improved disease signs
and symptoms as well as physical function, and inhibited progression of joint
damage.

"IL-6 blockade is emerging as an important therapeutic approach for rheumatoid
arthritis," said Neil Graham, M.B.B.S., M.D., M.P.H., Vice President, Program
Direction, Immunology and Inflammation, Regeneron Pharmaceuticals. "We are
encouraged with these Phase 3 results, which demonstrated efficacy at both
doses of sarilumab, each administered every other week."

The 52 week SARIL-RA-MOBILITY Phase 3 trial enrolled approximately 1,200
patients with active, moderate-to-severe rheumatoid arthritis, and who were
inadequate responders to MTX therapy. Patients were randomized to one of three
subcutaneous treatment groups, all in combination with MTX and dosed every
other week: sarilumab 200 milligrams (mg), sarilumab 150 mg, or placebo.

Both sarilumab groups showed clinically relevant and statistically significant
improvements compared to the placebo group in all three co-primary endpoints
(p<0.0001).

  (1) Improvement in signs and symptoms of RA at 24 weeks, as measured by the
  American College of Rheumatology score of 20 percent improvement (ACR20).

    o66 percent, 58 percent, and 33 percent in the sarilumab 200 mg,
      sarilumab 150 mg, and placebo groups respectively, all in combination
      with MTX.

  (2) Improvement in physical function, as measured by change from baseline in
  the Health Assessment Question-Disability (HAQ-DI) at week 16.

  (3) Inhibition of progression of structural damage at Week 52, as measured
  by the change in the modified Van der Heijde total Sharp score (mTSS).

    o0.25, 0.90, and 2.78 in the sarilumab 200 mg, sarilumab 150 mg, and
      placebo groups respectively, all in combination with MTX.
    oThe group receiving the 200 mg dose of sarilumab + MTX had a reduction
      of approximately 90 percent in the radiographic progression assessed by
      the mTSS compared to the radiographic progression with placebo + MTX at
      week 52.

  ACR Results at week 24

                         ACR20^ ACR50 ACR70
  Treatment Group
                         (%)    (%)   (%)
  200 mg sarilumab + MTX 66*    46*   25*
  150 mg sarilumab + MTX 58*    37*   20*
  Placebo + MTX          33     17    7

^Primary Endpoint
*p<0.0001 compared to placebo group

In the SARIL-RA-MOBILITY trial, there was a higher incidence of treatment
emergent adverse events leading to withdrawal in the sarilumab treatment
groups compared to placebo (13.9 percent in 200 mg, 12.5 percent in 150 mg and
4.7 percent in placebo).

Infections were the most frequently reported adverse events and were reported
with a higher incidence in the sarilumab groups compared to placebo, all in
combination with MTX (39.6 percent for 200 mg, 40.1 percent for the 150 mg
group and 31.1 percent for placebo). The incidence of serious infections was
4.0 percent in the 200 mg + MTX group, 2.6 percent in the 150 mg + MTX group,
and 2.3 percent in the placebo + MTX group. Among patients treated with
sarilumab, a dose dependent decrease in mean neutrophil counts was observed.
Serious infections were not associated with grades 3 and 4 neutropenia in this
study. Increases in mean LDL cholesterol, and transaminases were observed.
These safety findings were consistent with those observed in prior
investigational studies with sarilumab. 

"Irreversible joint damage can be a consequence for patients suffering from
rheumatoid arthritis, and this is accompanied by reduced physical function in
these patients," said Tanya M. Momtahen, M.S., Sarilumab Global Project Head,
Sanofi. "This remains a major concern for rheumatoid arthritis patients. We
are encouraged by these Phase 3 results and the impact sarilumab demonstrated
on inhibition of progression of structural damage assessed radiographically in
this study."

Additional analyses of efficacy and safety data from the SARIL-RA-MOBILITY
study will be presented at a future medical conference.

About Sarilumab
Sarilumab (REGN88/SAR153191) is the first fully-human monoclonal antibody
directed against the IL-6 receptor (IL-6R). Sarilumab is a subcutaneously
delivered inhibitor of IL-6 signaling, which binds with high affinity to the
IL-6 receptor. It blocks the binding of IL-6 to its receptor and interrupts
the resultant cytokine-mediated inflammatory signaling. Sarilumab was
developed using Regeneron's VelocImmune® antibody technology.

The investigational agent described above is currently under clinical
development and its safety and efficacy have not been fully evaluated by any
regulatory authority.

About Sanofi
Sanofi, an integrated 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
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, oncology,
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
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, 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, 2012. 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. 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 sarilumab; 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;
the likelihood and timing of possible regulatory approval and commercial
launch of Regeneron's late-stage product candidates; ongoing regulatory
obligations and oversight impacting Regeneron's research and clinical programs
and business; 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 and
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; 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 cancelled 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 and its Form 10-Q for the
quarterly period ended September 30, 2013. 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                                          Sebastien Martel
Cox
Tel.: + (33) 1 53 77 46 46   Tel.: + (33) 1 53 77 45 45
mr@sanofi.com       ir@sanofi.com
Regeneron Contacts:
Media Relations  Investor Relations
Sandy Sexton  Manisha Narasimhan, Ph.D.
Tel: 1 (914)                                  Tel: 1 (914) 847-5126
847-3358
sandra.sexton@regeneron.com  manisha.narasimhan@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.

Website: http://www.regeneron.com
 
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