Suliqua TM Approved in the European Union for the Treatment of Adults with Type 2 Diabetes Paris, France

SuliquaTM Approved in the European Union

for the Treatment of Adults with Type 2 Diabetes

Paris, France - January 17, 2017 - Sanofi announced today that the European Commission has granted

marketing authorization in Europe for SuliquaTM, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor

agonist lixisenatide for the treatment of adults with type 2 diabetes. Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral

glucose lowering medicinal product or with basal insulin.1

Suliqua is an innovative new

combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe, said Elias Zerhouni, M.D., President, Global R&D, Sanofi. The approval of Suliqua represents the

successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose. Sanofi has a long history of elevating care for people with diabetes, and we believe Suliqua

will make it easier for patients with inadequately controlled diabetes to reach their treatment goals.

The decision to grant marketing

authorization in Europe for Suliqua was based on data from two Phase 3 studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes

worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs and after basal insulin therapy, respectively. Suliqua demonstrated statistically superior blood sugar

(HbA1c) reduction versus lixisenatide (-0.8%, p<0.0001) and insulin glargine 100 Units/mL (-0.3%, p<0.0001)

in LixiLan-O, and versus insulin glargine 100 Units/mL (-0.5%, p<0.0001) in LixiLan-L.2,3

Suliqua will be delivered in two pre-filled SoloSTAR pens, providing different dosing options that may help answer individual market and patient insulin needs. The differentiation between the pen strengths is based on the dose range and ratios of

each pen. The 10 40 SoloSTAR pre-filled pen will deliver 10 to 40 dose steps of insulin glargine 100 Units/mL in combination with 5 to 20 micrograms of lixisenatide. The 30 60 SoloSTAR pre-filled pen will deliver 30 to 60 dose steps of insulin glargine 100 Units/mL in combination with 10 to 20 micrograms of lixisenatide.1

We welcome the addition of Suliqua in the EU to help address the needs of people living with type 2 diabetes who are currently not reaching their

blood sugar targets, said Javier Ampudia Blasco, Specialist of Endocrinology and Nutrition at the Clinic University Hospital Valencia and Associate Professor of Medicine at the Medicine Faculty of Valencia in Spain. It is important to

achieve glycemic control without increasing the risk of hypoglycemic events or additional weight gain when oral agents or basal insulin are no longer sufficient. The simple administration of this combination product of insulin and a glucagon-like peptide-1 receptor agonist in a single daily injection may help to reduce the daily complexity of diabetes management and improve efficacy for people with type 2 diabetes compared with its components. Suliqua is

easy to use with dose adjustments based only in the fasting glucose values.

Marketing authorization in Europe for Suliqua is applicable to the

28 member states of the European Union, as well as Iceland, Liechtenstein and Norway, and follows the November 2016 positive

opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The product was approved by the U.S. Food and Drug Administration (FDA) in

November 2016, as SoliquaTM 100/33, and has been available in the U.S. since January 4, 2017. Launches in individual EU countries are anticipated from Q2 2017 onward.

About Sanofi Diabetes & Cardiovascular

and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative,

value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and

other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.

Sanofi, a global healthcare leader,

discovers, develops and distributes therapeutic solutions focused on patients needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and

Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward-Looking Statements

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