Sanofi Provides an Update on its Research & Development Pipeline

PR Newswire/Les Echos/ 
    Sanofi Provides an Update on its Research & Development Pipeline 
Paris, France - January 8, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) today
will provide an update on its Research & Development (R&D) pipeline with Dr.
Elias Zerhouni, President, Global Research and Development, presenting at the 
JP Morgan Healthcare Conference in San Francisco, California. 
Highlights of the presentation will include key products in late stage
development in several disease areas with significant development and 
regulatory milestones in the next six months. Executing a successful strategy 
to reposition Sanofi R&D has fueled a pipeline with 65 NME (New Molecular 
Entity) projects and vaccine candidates in clinical development of which 17 are
in Phase III or have been submitted to the health authorities for approval. 
"Sanofi has made significant progress in the transformation of its R&D over the
last couple of years, including advances in late stage projects and early stage
pipeline as well as talent recruitment. We feel we have the ingredients to
ensure R&D contributes to Sanofi's goal of sustainable growth in the coming
years while rigorously managing R&D costs," said Dr. Elias Zerhouni. 
Regarding regulatory milestones, Sanofi received two positive opinions from the
Committee for Medicinal Products for Human Use (CHMP) since the last R&D update
on October 25, 2012, with decisions from the European Commission targeted in 
Q1 2013: Lyxumia(r) (lixisenatide) in type 2 diabetes and Zaltrap(r) 
(aflibercept) in metastatic second-line colorectal cancer. 
Portfolio update 
* SAR236553 (collaboration with Regeneron), a subcutaneously administered,
fully-human antibody, is being evaluated for its impact on lowering low-density
lipoprotein cholesterol (LDL-C) by targeting PCSK9. In November, Sanofi and
Regeneron announced that the ODYSSEY OUTCOMES trial, a Phase III cardiovascular
outcomes trial with SAR236553 started to recruit patients. This study will
enroll approximately 18,000 patients, who recently suffered an acute coronary
syndrome. With the start of this study, eleven Phase III trials are now
recruiting hypercholesterolemic patients not at goal for LDL-C and mainly at
high cardiovascular risk, a population estimated at 21 million people
* Clostridium Difficile Toxoid Vaccine, for the prevention of primary
symptomatic Clostridium Difficile infections (CDI), is expected to enter Phase
III in Q3 2013 in patients at high risk of CDI. In the U.S., a Fast Track
Development Program designation was granted by CBER (Center for Biologics
Evaluation and Research). CDI is the most common cause of healthcare related
infections in the developed world and is increasingly reported globally. 
* SAR231893 (collaboration with Regeneron), an anti IL-4R alfa monoclonal 
antibody with dual IL-4/IL-13 cytokine antagonism, will enter Phase IIb in 
mid-2013 in asthma and atopic dermatitis following positive proof of concept 
data for both indications. These data will be submitted for presentation at 
medical conferences in 2013. 
* SAR302503: In December, Sanofi announced that the Phase II trial evaluating
its JAK2 inhibitor in myelofibrosis met its primary endpoint. The data was
presented during the 2012 Annual Meeting of the American Society of Hematology.
Recruitment of the Phase III JAKARTA study is completed. 
* Aubagio(r) (teriflunomide): Sanofi has discontinued the TERACLES study. This
decision is based on recruitment challenges and an assessment of changing 
market dynamics which suggests that combining oral and injectable 
immunomodulatory platform multiple sclerosis therapies may not be a preferred 
treatment option. This decision is not related to any safety concern. 
* Ombrabulin: Results of the Phase III study in sarcoma did not demonstrate
sufficient clinical benefit to support regulatory submissions despite reaching
its primary endpoint of progression free survival and the phase II study in
ovarian cancer was terminated early based on an interim analysis. There were no
substantial safety concerns in these studies. We have informed our partner
Ajinomoto of our decision to discontinue this project. 
* SAR245408 (XL 147, partnership with Exelixis): The Phase II trial in
endometrial cancer has been discontinued. The study did not demonstrate
sufficient clinical benefit to pursue latestage trials in this indication.
SAR245408 is being examined in an ongoing Phase II trial in combination with
letrozole in breast cancer and in combination with SAR256212 in a Phase I 
Key development milestones expected in the next six months 
* Eliglustat: Phase III results of the ENCORE study evaluating the oral therapy
eliglustat vs. Cerezyme(r) in patients with Gaucher disease are expected in Q1
* Otamixaban: Phase III results of the TAO study evaluating otamixaban, the
first intravenous direct and selective factor Xa inhibitor with quick
onset/offset, are   expected in Q2 2013. 
* SAR302503: Headline results from the Phase III JAKARTA study in myelofibrosis
are expected in Q2 2013. 
* New glargine formulation: The first Phase III headline results in diabetes are
expected in Q2 2013. 
* Iniparib: Headline results from the Phase III in first-line squamous
non-small-cell lung cancer are expected in Q2 2013. 
Key regulatory milestones expected in the next six months 
* Zaltrap(r) (aflibercept, collaboration with Regeneron): The European
Commission decision in second-line metastatic colorectal cancer is targeted in
Q1 2013. 
* Lyxumia(r) (lixisenatide, licensed from Zealand Pharma): The European
Commission decision in type 2 diabetes is targeted in Q1 2013. The FDA decision
on file acceptance in type 2 diabetes in the U.S. is expected in Q1 2013. 
* Aubagio(r) (teriflunomide): The CHMP opinion for the treatment of relapsing
multiple sclerosis is expected in Q1 2013. 
* Lemtrada(TM)(1) (alemtuzumab): The CHMP opinion for the treatment of 
relapsing multiple sclerosis is expected in Q2 2013. The FDA decision on file 
acceptance is expected in Q1 2013. 
* Kynamro(TM) (mipomersen sodium, development partnership with Isis
Pharmaceuticals): The FDA decision for the treatment of patients with 
Homozygous Familial Hypercholesterolemia is expected in Q1 2013. In December, 
the CHMP adopted a negative opinion for its marketing authorization application
for the treatment of patients with Homozygous Familial Hypercholesterolaemia. 
Genzyme has requested a re-examination of the CHMP Opinion. 
* Vaxigrip(r) QIV IM (quadrivalent inactivated flu vaccine, intramuscular): The
submission of regulatory file in the EU is expected in Q1 2013. 
* Paediatric hexavalent vaccine (DTP-Hep B-Polio-Hib): The CHMP opinion is
expected in Q1 2013. 
* Fluzone(r) QIV IM (quadrivalent inactivated flu vaccine, intramuscular): The
FDA decision is expected in Q2 2013. 
(1) Lemtrada(TM) is being developed in multiple sclerosis in collaboration with
Bayer Healthcare 
About Sanofi
Sanofi, a global and diversified 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). 
Forward-Looking Statements
This press release contains forward-looking statements. 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, 2011. Other than as required by applicable law, Sanofi
does not undertake any obligation to update or revise any forward-looking
information or statements. 
Media Relations                Investor Relations
Jean-Marc Podvin               Sébastien Martel
+ (33) 1 53 77 46 46           + (33) 1 53 77 45 45
E-mail :         E-mail : 
The content and accuracy of news releases published on this site and/or 
distributed by PR Newswire or its partners are the sole responsibility of the 
originating company or organisation. Whilst every effort is made to ensure the 
accuracy of our services, such releases are not actively monitored or reviewed 
by PR Newswire or its partners and under no circumstances shall PR Newswire or 
its partners be liable for any loss or damage resulting from the use of such 
information. All information should be checked prior to publication. 
-0- Jan/08/2013 08:56 GMT
Press spacebar to pause and continue. Press esc to stop.