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Sanofi and Regeneron Announce New, Detailed Data from Positive Sarilumab Phase 3 Rheumatoid Arthritis Trial at EULAR

Sanofi and Regeneron Announce New, Detailed Data from Positive Sarilumab Phase
                    3 Rheumatoid Arthritis Trial at EULAR

Both doses of investigational drug sarilumab met all three co-primary
endpoints

New data include major clinical response rates and ACR20 scores at 52 weeks

PR Newswire

PARIS and TARRYTOWN, N.Y., June 12, 2014

PARIS and TARRYTOWN, N.Y., June 12, 2014 /PRNewswire/ --Sanofi (EURONEXT:
SANand NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
presented positive results from a phase 3 trial of investigational drug
sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders
to methotrexate (MTX) therapy. New data presented at the meeting showed that
sarilumab increased major clinical response rates defined as achieving an
ACR70 for at least 24 consecutive weeks and showed sustained improvement in
signs and symptoms of RA after 52 weeks, which were secondary endpoints of the
trial.

As previously announced, in this study, called SARIL-RA-MOBILITY, sarilumab
met all three co-primary endpoints, demonstrating improvement in disease signs
and symptoms at 24 weeks, physical function at 16 weeks and inhibition of
joint damage progression at 52 weeks. These data will be presented today at
the European League Against Rheumatism Annual Congress (EULAR 2014) Congress
in Paris, France.

"Despite notable advances, many RA patients continue to struggle with
debilitating signs and symptoms, underscoring a clear need for additional
options," said Dr. Mark Genovese, Professor, Stanford University Medical
Center and lead investigator in the study. "Sarilumab showed efficacy in this
study at two different doses, both delivered subcutaneously every other week.
We look forward to the results of ongoing trials in this comprehensive
registration program."

The SARIL-RA-MOBILITY Phase 3 trial enrolled 1,197 adult patients with active,
moderate-to-severe rheumatoid arthritis, who were inadequate responders to MTX
therapy. Patients were randomized to one of three treatment groups dosed
subcutaneously every other week, sarilumab 150 milligrams (mg), sarilumab 200
mg, or placebo, all in combination with MTX.

Both sarilumab groups showed 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).
    These results were 58 percent, 66 percent, and 33 percent in the sarilumab
    150 mg, sarilumab 200 mg, and placebo groups respectively, all in
    combination with MTX.
2.Improvement in physical function at Week 16 as measured by Health
    Assessment Questionnaire - Disability Index (HAQ-DI). Newly presented
    HAQ-DI results were -0.53, -0.55, and -0.29 in the sarilumab 150 mg,
    sarilumab 200 mg, and placebo groups respectively, all in combination with
    MTX.
3.Inhibition of progression of structural damage at Week 52, as measured by
    change in the van der Heijde modified total Sharp score (mTSS). These
    results were 0.90, 0.25, and 2.78 in the sarilumab 150 mg, sarilumab 200
    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.

Also newly presented, both sarilumab groups also showed improvement on the
major clinical response secondary endpoint:

  oSarilumab combined with MTX demonstrated statistically significantly
    greater effect than MTX alone in achieving a major clinical response,
    defined as reducing signs and symptoms of RA by 70% or more, as measured
    by improvement of the American College of Rheumatology score (ACR70
    response), for at least 24 consecutive weeks. These results were 13
    percent, 15 percent and 3 percent in the sarilumab 150 mg, sarilumab 200
    mg, and placebo groups, respectively (p<0.0001).

Both doses also demonstrated a sustained response in improvement of signs and
symptoms of RA compared to placebo at 52 weeks as measured by the ACR20
response. These results were 54 percent, 59 percent, and 32 percent in the
sarilumab 150 mg, sarilumab 200 mg, and placebo groups, respectively.

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 (12.5 percent in 150 mg, 13.9 percent in
200 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 (40.1
percent for 150 mg, 39.6 percent for the 200 mg group and 31.1 percent for
placebo). The incidence of serious infections was 2.6 percent in the 150 mg +
MTX group, 4.0 percent in the 200 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. 

The sarilumab Phase 3 program, known as SARIL-RA, has six ongoing clinical
studies and is targeted to enroll approximately 2,800 RA patients.

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 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 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
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, 2013. 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,
such as the SARIL-RA-MOBILITY study and the other SARIL-RA trials; the
likelihood and timing of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates, including without limitation
sarilumab; 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, 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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