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Genzyme and Veracyte Announce Global Co-Promotion Agreement to Deliver Personalized Solution for Thyroid Patients

CAMBRIDGE, Mass. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY) and one of the world’s leading biotechnology companies, and Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced a global co-promotion partnership to provide a comprehensive solution for thyroid patients. The arrangement will give patients worldwide increased access to an advanced personalized medicine solution for improved diagnosis of thyroid nodules, and the potential to significantly reduce the number of unnecessary thyroidectomies.

“Together, our products offer patients and physicians a powerful personalized medicine solution for the diagnosis and treatment of thyroid cancer, addressing an unmet need in the community and improving patient outcomes.”

Under terms of the agreement, Genzyme will market and promote Veracyte’s Afirma® Thyroid FNA Analysis, an innovative and novel approach for improved thyroid nodule diagnosis, in the United States and, subsequently, in global markets. Financial terms of the deal were not disclosed.

Thyroid cancer is the fastest-growing cancer in the U.S., with an estimated 56,460 new cases expected in 2012, according to the American Cancer Society. An estimated 450,000 thyroid nodule fine needle aspirations (FNAs) – a minimally invasive procedure to extract suspicious cells for examination under a microscope – are performed in the U.S. each year to rule out cancer. Thyroid nodule FNAs are challenging to interpret, however, producing ambiguous results in up to 30 percent of cases. Current guidelines recommend that most of these patients undergo thyroid resection for a definitive diagnosis, given that thyroid cancer is highly treatable. Post-surgical results, however, show that only 20-30 percent of these patients have cancer.

Veracyte’s novel solution combines expert cytopathology assessment of thyroid nodule FNA samples, with the company’s Afirma Gene Expression Classifier used to resolve indeterminate results and thus help patients with benign nodules avoid unnecessary surgery. Two independent clinical studies – both part of a large, multicenter, prospective clinical trial involving academic and community sites – have shown that the Afirma Gene Expression Classifier can reclassify patients with indeterminate thyroid FNA results as “benign” with the same degree of accuracy as a benign cytopathology diagnosis. Veracyte announced recently that its Afirma Gene Expression Classifier has been granted coverage for Medicare patients nationwide.

Genzyme is an established leader in endocrinology globally, developing and marketing Thyrogen® (thyrotropin alfa for injection) for patients with well-differentiated thyroid cancer. Thyrogen is used as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging. Thyrogen is also approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer.

“This partnership is a strong fit for both companies and underscores Genzyme’s commitment to improving the quality of care for patients with suspected or diagnosed thyroid cancer,” said Genzyme’s Head of Rare Diseases, Rogerio Vivaldi, M.D. “Together, our products offer patients and physicians a powerful personalized medicine solution for the diagnosis and treatment of thyroid cancer, addressing an unmet need in the community and improving patient outcomes.”

“We are delighted to join forces with Genzyme,” said Bonnie Anderson, Veracyte’s Cofounder and CEO. “This powerful partnership will enable us to utilize Genzyme’s specialized endocrinology sales force and marketing infrastructure to commercialize our Afirma Thyroid FNA Analysis more quickly in the U.S. and globally. In addition to benefitting patients, our solution will improve the cost-effectiveness of thyroid nodule diagnosis worldwide.”

A recent economic impact study, published in the Journal of Clinical Endocrinology & Metabolism, concluded that routine use of the Afirma Gene Expression Classifier in the U.S. would prevent tens of thousands of avoidable surgeries each year and would provide more than $600 million in direct medical savings over 5 years.

About Veracyte

Veracyte, Inc., based in South San Francisco, Calif., is pioneering the emerging field of molecular cytology, applying molecular biomarkers to cytology samples in order to improve disease diagnosis by clarifying indeterminate results obtained from current methods. The company aims to enable doctors to make more informed treatment decisions that improve patient care and provide cost savings to the healthcare system. The company utilizes rigorous science and an extensive, multicenter clinical program throughout discovery and development. Veracyte’s first product – the Afirma Thyroid FNA Analysis – combines expert cytopathology assessment with the Afirma Gene Expression Classifier, a genomic test that clarifies inconclusive thyroid nodule results as benign or suspicious for cancer. The company is currently in the early biomarker discovery phase for lung cancer and interstitial lung diseases. Veracyte is privately held and funded by Domain Associates, Kleiner Perkins Caufield & Byers, TPG Biotech and Versant Ventures. For more information, visit www.veracyte.com.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Genzyme® and Thyrogen® are registered trademarks of Genzyme Corporation. Veracyte® and Afirma® are registered trademarks of Veracyte, Inc. All rights reserved.

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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Contacts

For Genzyme:
Lori Gorski, 617-768-9344
Lori.gorski@genzyme.com
or
For Veracyte:
Tracy Morris, 650-473-1272 (o)
650-380-4413 (c)
tracymorrispr@gmail.com

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