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FDA Approves Toujeo (insulin glargine) Max SoloStar

BRIDGEWATER, N.J., March 27, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market.

The new Max SoloStar pen holds 900 Units of Toujeo, more than any other long-acting insulin pen in the U.S., and provides up to 160 Units/mL of Toujeo in a single injection.

Due to its higher capacity, Max SoloStar may reduce the number of pens adults prescribed Toujeo use, allowing for fewer refills and related copays, depending on the person's insurance coverage. The maximum dose of up to 160 Units/mL may also help reduce the number of injections needed to deliver the required Toujeo dosage for some adults with diabetes.

"This new high capacity pen has a broader range of doses than the original SoloStar, delivering Toujeo, a long-acting insulin with established safety and efficacy," said Michelle Carnahan, North America Diabetes and Cardiovascular Head, Sanofi. "By reducing the number of injections for people who need more long-acting insulin and lowering copay costs – both of which are important to patients – Toujeo Max SoloStar underscores Sanofi's continued commitment to help those living with diabetes."

To make Toujeo Max SoloStar as financially accessible as possible, it will be available at the same price as the original Toujeo SoloStar per insulin unit. Additionally, Sanofi will offer a savings program for Toujeo that includes both the SoloStar pen and Max SoloStar pen. Eligible commercially insured patients will pay a $0 copay if they are new to Toujeo for their first three prescription fills, and a $10 copay for their next 12 fills.

Sanofi will also offer support to adults with diabetes prescribed either SoloStar or Max SoloStar through the free Toujeo COACH program. For more information about these programs, visit www.toujeo.com.

Toujeo Max SoloStar will launch in retail pharmacies across the U.S. in Q3 2018.

About Sanofi

Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks 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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi

Posted: March 2018

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