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Sanofi Regulatory Filings 2012

Oct 9, 2012

1643_iss_2012-10-09_34e1a736-c34d-4cb2-91c0-f32c2aba84c8.pdf

Regulatory Filings

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Sanofi to Launch State-of-the Art, Reusable Insulin Pen AllStar™ in India

- Sanofi shows its continued commitment to patients' needs in emerging markets and improves access to innovative, affordable devices –

Paris, France – October 9, 2012 – Sanofi (EURONEXT: SAN and NYSE: SNY) announced today the launch by Sanofi India Limited of AllStar™, the first Indian-manufactured, re-usable insulin pen, manufactured by a global company in India. Developed especially for patients in emerging markets, AllStar™ is indicated for use of insulinized patients using Sanofi's insulin portfolio, and also for insulin-naive patients who are starting to use insulin. The AllStar™ re-usable insulin pen conforms to ISO (International Organization for Standardization) standards and is equipped with state-of-theart features.

AllStar™ will be commercially launched in India this October. The launch of AllStar™ is a significant milestone emblematic of Sanofi's leadership in addressing the needs of people with diabetes in India. It highlights Sanofi's commitment to diabetes and emerging markets and its regionalized approach to finding solutions that are adapted to local market needs. Going forward, Sanofi intends to make AllStar™ accessible to other emerging markets.

"Sanofi has always been at the forefront of diabetes research and development. AllStar™ is a testament to Sanofi's patient-centric approach and leverages our strong commitment to embracing innovation coming from emerging markets like India," says Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "Sanofi India's manufacturing its own re-usable insulin device is the results of three years of exemplary team work with the sole purpose of offering a device that would match the needs of people with diabetes in India and other emerging markets."

AllStar™ is a state-of-the-art device that is easy-to-use for patients, and also supports physicians in early initiation of insulin therapy for better glycemic control and enhanced therapeutic outcomes.

About AllStar

AllStar™ is the result of a successful collaborative multidisciplinary, cross-functional and multicountry effort lead by Industrial Development within Sanofi that brought together technology, resources and intellectual capital to develop a pen that patients aspire for; one that combines convenience and affordability. AllStar™ is a combination of sleek design styling with easy-to-use, yet sophisticated technology.

With close to 63 million people with diabetes in India, of whom many are either undiagnosed or have uncontrolled diabetes because of poor compliance, diabetes is a major health problem in India. Given the social and economic impact of diabetes, Sanofi finds it critical to invest in local talent to bring innovative devices to local patients.

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes.

Investigational compounds in the pipeline include an injectable GLP-1 receptor agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.

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.

Contacts:

Marisol Péron Sébastien Martel + (33) 1 53 77 46 46 + (33) 1 53 77 45 45 E-mail : [email protected] E-mail : [email protected]

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