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.