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Sanofi and Regeneron Report Positive Top-line Results with Alirocumab from First Phase 3 Study of a PCSK9 Inhibitor for LDL


PR Newswire/Les Echos/

PRESS RELEASE


    Sanofi and Regeneron Report Positive Top-line Results with Alirocumab from 
     First Phase 3 Study of a PCSK9 Inhibitor for LDL Cholesterol Reduction
    - alirocumab monotherapy reduced "bad" cholesterol three times more than
                                   ezetimibe -

Paris, France, and Tarrytown, NY, October 16, 2013 -- Sanofi (EURONEXT: SAN and
NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the Phase 3 ODYSSEY MONO trial with alirocumab, an investigational
monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin 
type 9), met its primary efficacy endpoint. The mean lowdensity
lipoprotein-cholesterol (LDL-C, or "bad" cholesterol) reduction from baseline 
to week 24, the primary efficacy endpoint of the study, was significantly 
greater in patients randomized to alirocumab, as compared to patients 
randomized to ezetimibe (47.2% vs. 15.6%, p<0.0001). In the trial, which 
employed a dose increase (up-titration) for patients who did not achieve an 
LDL-C level of 70 milligrams/deciliter (mg/dL), the majority of patients 
remained on the initial low dose of alirocumab of 75 milligrams (mg).

"We are excited with the findings from the first Phase 3 trial with alirocumab.
While the majority of our clinical program is investigating alirocumab in
combination with lipid-lowering therapies, these monotherapy results are
encouraging," said Jay Edelberg M.D., Ph.D., Head of the PCSK9 Development and
Launch Unit, Sanofi Group. "As in this trial, several of our Phase 3 studies
will utilize an up-titration approach, the aim of which is to bring patients to
goal with the lowest effective dose of anti-PCSK9 antibody. We look forward to
results from the remaining Phase 3 trials, which are investigating alirocumab 
in a variety of patient populations, combinations with different background
therapies, and dosing regimens."

The percentage of patients who reported treatment emergent adverse events was
78.4% in the ezetimibe group and 69.2% in the alirocumab group. The most common
class of adverse events was infections (39.2% with ezetimibe vs. 42.3% with
alirocumab), which included nasopharyngitis, influenza, and upper respiratory
tract infection. Injection-site reactions occurred in less than 2% of patients
in both groups. Muscle-related adverse events occurred in 3.9% of patients
treated with ezetimibe and 3.8% of patients treated with alirocumab.

ODYSSEY MONO is the first study to report data from the 12 Phase 3 trials that
have been initiated so far as part of the more than 23,000 patient ODYSSEY
clinical trial program.

"There are still millions of people around the globe who have poorly controlled
LDL-C," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of
Regeneron and President of Regeneron Laboratories. "Three years ago, our Phase
1 trials generated the first clinical evidence that blocking PCSK9 could 
markedly lower cholesterol levels in humans. Today, it is very gratifying to 
be able to report the first Phase 3 data for this promising potential new 
class of lipid-lowering agents. It is important to point out that these are 
just the first of a large amount of data yet to come from our extensive 
ODYSSEY Phase 3 program."

ODYSSEY MONO (N=103) was a randomized, double-blind, active-controlled,
parallel-group study to evaluate the efficacy and safety of alirocumab over 24
weeks in patients with primary hypercholesterolemia and moderate cardiovascular
risk. Patients in the trial were randomized to receive monotherapy with either
ezetimibe 10 mg, an alternative to statin therapy, or alirocumab. Alirocumab 
was self-administered initially at its low dose of 75 mg every two weeks, and 
was uptitrated at week 12 to 150 mg if the LDL-C measurement at week 8 was 
above 70 mg/dL. The majority of alirocumab patients in the trial remained on 
the initial low dose of alirocumab because they achieved LDL-C below 70 mg/dL 
at week 8. Alirocumab was self-administered subcutaneously using a single-use 
1 milliliter (mL) auto-injector.

Detailed results from the ODYSSEY MONO study will be presented at an upcoming
medical conference in 2014.

About ODYSSEY
The global Phase 3 ODYSSEY program is expected to enroll more than 23,000
patients and currently includes 12 clinical trials of alirocumab both in
combination with other lipid-lowering agents and as monotherapy. The primary
Phase 3 study endpoint is the percent mean reduction in LDL-C at 24 weeks,
giving a robust measure of efficacy and safety. In addition, several other 
lipid markers will also be assessed.

The ODYSSEY
Phase 3 trials are designed to create different options to help meet the needs
of individual patients. In addition to the up-titration option explored in this
study in which patients received a 75 mg Q2W (once every two weeks) dose of
alirocumab, and were only be up-titrated to 150 mg Q2W if they were unable to
reach prespecified target LDL-C levels, the other ODYSSEY trials are also
exploring initiating patients with a 150 mg every two week regimen (intended 
for patients needing a larger reduction in LDL-C), as well as regimens 
evaluating alirocumab dosed once every four weeks.

All of the ODYSSEY trials, with the exception of ODYSSEY CHOICE I and ODYSSEY
OUTCOMES, are fully enrolled. For more information on the ODYSSEY clinical
trials, please visit http://www.odysseytrials.com.

About PCSK9
PCSK9 is known to be a determinant of circulating LDL levels, as it binds to 
LDL receptors resulting in their degradation so that fewer are available on 
liver cells to remove excess LDL-cholesterol from the blood. Moreover, 
traditional LDL-lowering therapies such as statins actually stimulate the 
production of PCSK9, which limits their own ability to lower LDL-cholesterol. 
Blocking the PCSK9 pathway is therefore a potentially novel mechanism for 
lowering LDL-cholesterol.

About alirocumab
Alirocumab is an investigational, fully-human monoclonal antibody that targets
and blocks PCSK9. It is administered via subcutaneous injection. By inhibiting
PCSK9, a determinant of circulating LDL-C levels in the blood, alirocumab has
been shown in pre-clinical studies to increase the number of LDL receptors on
hepatocytes, thereby lowering LDL-C.

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 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, de vice 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 bene fit 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 alirocumab; 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; 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 quarter ended June 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.

Contacts: 

Sanofi:

Media Relations                      Investor Relations
Jack Cox                             Sébastien Martel
Tel: +33 (0) 1 53 77 94 74           Tel: +33 (0)1 53 77 45 45
Mobile: +33 (0) 6 78 52 05 36        E-mail: IR@sanofi.com 
E-mail: Jack.cox@sanofi.com 

Regeneron:

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- Oct/16/2013 06:50 GMT

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