Sanofi: FDA Accepts Sanofi's New Drug Application for Basal Insulin Toujeo®

 Sanofi: FDA Accepts Sanofi's New Drug Application for Basal Insulin Toujeo®

                  FDA Accepts Sanofi's New Drug Application
                           forBasal InsulinToujeo^®

                  - Toujeo dossier already accepted by EMA -

Paris, France - July 8, 2014 - Sanofi (EURONEXT: SAN and NYSE: SNY)  announced 
today that  the U.S.  Food and  Drug Administration  (FDA) has  accepted  for 
review the company's New Drug Application (NDA) for Toujeo^® (insulin glargine
[rDNA origin]  injection,  300  U/mL),an investigational  basal  insulin.  The 
acceptance of the NDA  follows the acceptance  of the marketing  authorization 
dossier for Toujeo by the European Medicines Agency (EMA) for EU countries  on 
May 27, 2014.

"By reaching this  key milestone in  the approval process,  we are pleased  to 
take another step forward  with Toujeo, an  investigational new basal  insulin 
that has been evaluated in a broad range of people living with diabetes," said
Pierre Chancel, Senior Vice  President, Global Diabetes  at Sanofi. "With  the 
FDA's acceptance  of  our  submission,  we  are  anticipating  the  regulatory 
decision for marketing authorization for Toujeo in the U.S. in the first  half 
of 2015."

The NDA  for  Toujeo is  based  on results  from  the EDITION  clinical  trial 
program, which  is a  worldwide  and extensive  series  of Phase  III  studies 
evaluating the efficacy and safety of  Toujeo in over 3,500 people from  broad 
and diverse diabetes populations.

Toujeo is the  trade name for  insulin glargine [rDNA  origin] injection,  300 
U/mL; formerly  abbreviated  as "U300".  U300  is not  currently  approved  or 
licensed anywhere in the world.

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).

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.

Contacts:                      Investor Relations
                               Sébastien Martel
Media Relations                Tel.: + (33) 1 53 77 45 45
Jack Cox                       ir@sanofi.com
Tel.: + (33) 1 53 77 94 74
jack.cox@sanofi.com
Global Diabetes Communications U.S. Diabetes Communications
Tilmann Kiessling              Susan Brooks
Mobile: +(49) 17 26 15 92 91   Office: +1 (0) 908 981 6566
Tilmann.kiessling@sanofi.com   Mobile: +1 (0) 201 572 49 94
                               susan.brooks@sanofi.com

PDF Version

------------------------------------------------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf
of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for
the content, accuracy and originality of the information contained therein.
Source: Sanofi via Globenewswire
HUG#1816570
 
Press spacebar to pause and continue. Press esc to stop.