Paris, France, May 28, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY) announced today the inauguration of a new assembling and packaging line to produce its flagship pre-filled insulin injection pen Lantus® SoloSTAR® at its Beijing plant located at the Beijing Economic-Technological Development Area (BDA). Presiding over the inauguration ceremony, Christopher A. Viehbacher, Chief Executive Officer of Sanofi, announced the second phase of the US$90 million project to install a high-tech cartridge aseptic production line. With a designed capacity of 48 million units per year, the facility is expected to help fulfil the needs of people with diabetes and ultimately improve the standard of diabetes care in China.
Senior officials from the Beijing municipal government, Beijing Food and Drug Administration, and the Beijing Economic-Technological Development Area attended the inauguration ceremony. They recognized Sanofi for its contribution to the development of the biopharmaceutical industry in Beijing. In 2010, the Beijing municipal government launched a strategic initiative to stimulate the growth of the biopharmaceutical industry and recognized a group of companies including Sanofi.
Lantus® (insulin glargine) is the most widely used insulin worldwide, backed by 47 million patient-years of experience by type 1 and type 2 diabetes patients. Lantus® is prefilled in the award-winning disposable insulin pen SoloSTAR® for administration in a precise and easy way. Since its launch in China in 2008, Lantus®SoloSTAR® has transformed patient experience with insulin injections and enhanced the quality of care for millions of people suffering from diabetes.
“The local production of Lantus®SoloSTAR® marks an important milestone for Sanofi’s commitment to China and our global commitment to fighting diabetes,” declared Mr. Viehbacher. “As a member of the Chinese society, we have a responsibility to work with the government, the scientific community, and patients to control the epidemic of diabetes. In the coming years, Sanofi will bring integrated and personalized solutions to Chinese patients, including oral anti-diabetic drugs, insulins, glucose monitoring devices, and enhanced services to help patients achieve better outcomes. We will also seek ways to broaden patient access to Lantus,” added Mr. Viehbacher.
Sanofi’s diabetes portfolio also includes the novel blood glucose meters BGStar® and iBGStar®. Launched in many European countries in 2011 and 2012, these easy-to-use, convenient and accurate blood glucose monitoring devices represent integrated solutions which seamlessly fit the lives of now more than a hundred thousand insulin users. The iBGStar®, which directly connects to the iPhone® and iPod touch®*, comes with innovative data management options that can be personalized such as an App and blood glucose trend charts. This enables users to monitor and manage their diabetes at any time and place. Both iBGStar® and BGStar® are expected to be made available in China in the near future. Later this year, Sanofi will launch Apidra®, a rapid-acting insulin for patients with type 1 and advanced type 2 diabetes. It is widely used with long-acting insulin or basal insulin analog such as Lantus®. In addition, Lyxumia® (Lixisenatide)**, a glucagon-like peptide-1 agonist (GLP-1), is under global development for the treatment of patients with type 2 diabetes mellitus. Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.
Sanofi continues to collaborate with the government and the scientific community to improve diabetes management by better understanding the disease, training physicians, and educating patients. In 2011, Sanofi supported the launch of “China Initiative for Diabetes Excellence,” a five-year initiative led by the Bureau of Disease Prevention and Control of MOH and undertaken by the Chinese Center for Disease Control and Prevention (CDC), the Chinese Diabetes Society (CDS) and World Health Organization Collaboration Center at the International Diabetes Center (IDC) to develop 500 future leaders of diabetes care and train 10,000 community and county doctors. In the clinical research field, Sanofi has collaborated with CDS and supported major programs including a landmark “China Type 2 Diabetes Research Project” involving 46,000 diabetic and non-diabetic patients, and a large-scale “Observational Registry for Basal Insulin Treatment - ORBIT Study”. The company’s commitment also extends to type 1 diabetes through its support to CDS and the International Diabetes Federation (IDF) to launch an innovative study in 2011 – “3C Study on Type 1 Diabetes in China”, to understand coverage, cost and patient care.
About Lantus® and Lantus® SoloSTAR®
Lantus® is a 24-hour basal insulin without a pronounced peak, and therefore efficaciously and safely lowers blood glucose. Lantus® is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and pediatric patients (6 years of age and older)* with type 1 diabetes mellitus. Lantus® demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours. Lantus® was launched in China in 2004.
SoloSTAR® is an easy-to-use disposable pen for the administration of Lantus®. SoloSTAR® allows the administration of doses from 1 up to 80 units, in one unit increments, in one injection. SoloSTAR® is small, discreet and eliminates the need for the patient to change insulin cartridges.
The Chicago Athenaeum Museum of Architecture and Design awarded a 2007 GOOD DESIGN™ Award for the SoloSTAR® disposable insulin injection pen. The Museum’s historic GOOD DESIGN program was founded in Chicago in 1950 by Edgar J.Kaufmann, Jr. with the participation of some of America’s most important designers. Every year the jury meets in New York and selects products and graphics worthy of the GOOD DESIGN Award for distinction in design. GOOD DESIGN remains the oldest and most important Awards program worldwide.
*Apple, the Apple logo, iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
**Sanofi has obtained from Zealand Pharma A/S (Copenhague, Danemark, www.zealandpharma.com) under a license the right to develop this product.
*** Refer to the global indication.
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).
About Sanofi China
Sanofi is one of the first foreign pharmaceutical companies to open offices in China. It is also one of the fastest growing healthcare companies with a diversified business ranging from pharmaceuticals, vaccines and consumer healthcare to rare diseases (Genzyme) and animal health (Merial). Sanofi currently employees over 6,000 people in more than 200 cities in China.
Sanofi has six manufacturing facilities in China in order to meet the increasing demand of the Chinese market. These six plants are located in Beijing, Hangzhou (two plants), Shenzhen, Tangshan and Nanchang.
Sanofi is engaged in integrated R&D in China, from drug target identification to late-stage clinical studies. Its China and Asia Pacific R&D Center is located in Shanghai.
For more information, please visit www.sanofi.cn.
About Beijing Economic and Technological Development Area
The Beijing Economic and Technological Development Area was established in 1992. It was approved by the State Council as a National Economic and Technological Development Zone. The Beijing Economic and Technological Development Area covers a total area of 46.8 square kilometres, and is home to approximately 2,000 enterprises with 20 billion USD investment.
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 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.
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