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

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

- Toujeo dossier already accepted by EMA -

PR Newswire

PARIS, July 8, 2014

PARIS, July 8, 2014 /PRNewswire/ --Sanofi (EURONEXT: SAN and NYSE: SNY)
announced today thatthe 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).

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SOURCE Sanofi

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