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

PR Newswire/Les Echos/ 
PRESS RELEASE 
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) -

Paris, France and Tarrytown, NY - November 22, 2013 - Sanofi (EURONEXT : SAN 
and 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).
    * 66 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).
  * 0.25, 0.90, and 2.78 in the sarilumab 200 mg, sarilumab150 mg, and placebo 
groups respectively, all in combination with MTX.
  * The 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

Treatment Group          ACR20 ^  ACR50     ACR70


                      (%)      (%)       (%)
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 
IL6 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(r) 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, 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, 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
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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
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impacting  Regeneron's  research  and  clinical  programs  and  business; 
determinations  by regulatory and administrative governmental authorities which
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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
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including Medicare and Medicaid; unanticipated expenses; the costs of
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assumptions underlying those projections or guidance; the potential for any
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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 Cox                                 Sébastien Martel
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) 847-3358                    Tel: 1 (914) 847-5126
sandra.sexton@regeneron.com              manisha.narasimhan@regeneron.com 
                  
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-0- Nov/22/2013 07:59 GMT
 
 
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