Sanofi Biosurgery Product MACI® Demonstrates Statistically Significant Clinical Outcomes Compared to Microfracture

BRIDGEWATER, N.J., July 12, 2012 /PRNewswire/ -- Sanofi US announced today that its product MACI® (matrix-induced autologous chondrocyte implant) met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage. MACI uses a patient's own (autologous) cultured cartilage cells (chondrocytes) to repair articular cartilage defects in the knee joint. The results from this pivotal safety and efficacy phase 3 trial comparing MACI to microfracture (SUMMIT) will be included as part of an ongoing EMA marketing authorization application and as part of a future FDA biologics license application in the United States.

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The trial enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in their knees.  Analysis of the clinical data showed a statistically significant improvement in the primary endpoint for those patients treated with MACI compared to microfracture.  In addition, this difference met the pre-specified threshold for a clinically meaningful difference.

"MACI may offer orthopaedic surgeons an advanced, minimally invasive product to treat patients with debilitating knee pain from articular cartilage injuries in the knee," said Leanna Caron, Vice President and General Manager of Sanofi Biosurgery's Cell Therapy and Regenerative Medicine Division.  "Successful treatment can significantly reduce pain and permit patients to regain function. The success of the SUMMIT trial is an important step to support our ongoing EMA marketing authorization application and a future FDA biologic license application in the United States which would be the next step in bringing this next generation of cartilage repair therapy to patients in the United States."

The data from the study will be shared at a major scientific meeting and published in a prominent medical journal early next year.

Cell Therapy Expertise at Sanofi

Genzyme Corporation, which was acquired by Sanofi in April 2011, has more than twenty years of experience in cell therapy and regenerative medicine and has developed proprietary process and assays for differentiating autologous cells for the production of its cell based products requiring  rigorous process controls and testing.  Currently, three cell-based products are commercialized globally, each pioneering in their own right. 

About Sanofi Biosurgery

Sanofi Biosurgery is a global strategic business unit of Sanofi. It develops and markets innovative, biologically based products for osteoarthritis relief, adhesion prevention, cartilage repair, and severe burn treatment. Sanofi Biosurgery's products include: Synvisc®, Synvisc-One™ (hylan G-F 20), Carticel® (autologous cultured chondrocytes), MACI® (Matrix-induced Autologous Chondrocyte Implantation), Seprafilm® and Epicel® (cultured epidermal autografts). Sanofi Biosurgery is committed to transforming disease management through innovative medical interventions.

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, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

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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 labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products 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 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, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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SOURCE Sanofi US