Sanofi and TB Alliance Announce Collaboration to Accelerate New Treatments Against Tuberculosis

- Goal is to select novel clinical development candidates to help stop the global pandemic -

Paris, France and New York, New York, September 20, 2012 - Sanofi (EURONEXT: SAN and NYSE: SNY) and the Global Alliance for TB Drug Development (TB Alliance) announced today a new research collaboration agreement to accelerate the discovery and development of novel compounds against tuberculosis (TB), a deadly infectious disease that resulted in almost 1.5 million deaths worldwide [1] in 2010.

Under the agreement, Sanofi and TB Alliance will collaborate to further optimize and develop several novel compounds in Sanofi’s library that have demonstrated activity against Mycobacterium tuberculosis, the bacterium that causes TB. This includes in-depth research of lead compounds based upon identified chemical derivatives of natural products, which have promising potential to treat all forms of TB, and the chemical optimization of other series of compounds that have been identified as hits through high-throughput screening.

“Sanofi’s long-standing commitment to delivering treatments for people living with tuberculosis- including the discovery of rifampicin, the gold-standard drug for tuberculosis treatment, as well as the manufacture of TB treatments - continues with this collaboration,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “By continuing our excellent partnership with the TB Alliance and leveraging our joint resources, we hope to find together new options to fight this dreaded global disease.”

“In working with Sanofi, we seek a common goal – to give patients and physicians significantly more effective treatments for TB and drug-resistant TB,” said Mel Spigelman, M.D., President and Chief Executive Officer, TB Alliance. “Without new regimens, we cannot stop this global pandemic.”

In 2010, TB affected nearly 9 million people [2] globally. The cost of diagnosing and treating these cases between 2009 and 2015 was estimated at $16.9 billion, with annual costs increasing from $700 million in 2009 to $4.4 billion in 2015.[3]Current TB treatments require patients to take multiple antibiotics for six to 24 months or longer [4], a treatment that is difficult for many patients to complete, leading to noncompliance. Noncompliance can result in the development of drug-resistant strains, such as multi-drug resistant TB (MDR-TB) or extensively drug-resistant TB (XDR-TB), or death.[5] In fact, a recent Lancet study led by Tracy Dalton from the United States Centers for Disease Control and Prevention indicates XDR-TB has been reported in 77 countries worldwide and MDR-TB and XDR-TB are both at higher levels than previously estimated.[6] The health consequences of TB and reported increases in MDR-TB and XDR-TB, along with increasing treatment costs underscore the urgent need for new, better, faster-acting treatments.

About the Global Alliance for TB Drug Development
The TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with the support of the Bill & Melinda Gates Foundation, the United Kingdom Department for International Development (DFID), Irish Aid, the United States Agency for International Development (USAID), National Institute of Allergy and Infectious Disease (NIAID), and the United States Food and Drug Administration (FDA). For more information on TB drug development and the TB Alliance, please visit www.tballiance.org.

Sanofi’s Involvement in Tuberculosis
Sanofi, which discovered rifampicin in the early 1960s, markets several anti-tuberculosis drugs. With the Impact TB initiative, which is part of its Access to Medicines program, Sanofi provides quality drugs at an affordable price and is also actively researching new therapeutic approaches for tuberculosis. The goal of the tuberculosis program is to offer health authorities in the affected countries a range of high-quality anti-tuberculosis products, as well as tailored support initiatives, as part of the fight against the disease. 

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). 

References
[1] World Health Organization. WHO Report 2011: Global Tuberculosis Control. World Health Organization, 2011. p. 3, para. 4.
[2] World Health Organization. WHO Report 2011: Global Tuberculosis Control. World Health Organization, 2011. p. 1, para. 3.
[3] Donald, P. R. and van Helden, P. D. The global burden of tuberculosis: Combating drug resistance in difficult times. New England Journal of Medicine, 2009; 360(23): 2393.
[4] Centers for Disease Control and Prevention. TB: Treatment. Accessed  May 4, 2012, at http://www.cdc.gov/tb/topic/treatment/default.htm.
[5] Centers for Disease Control and Prevention. Self-study Modules on Tuberculosis: 9 – Patient Adherence to Tuberculosis Treatment. Accessed  May 4, 2012, a http://www.cdc.gov/tb/education/ssmodules/pdfs/9.pdf.
[6] Dalton T, et al. Prevalence of and risk factors for resistance to second-line drugs in people with multidrug-resistant tuberculosis in eight countries: a prospective cohort study. Lancet, 2012; doi: 10.1016/S0140-6736(12)60734-X.

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 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:
Sanofi                                                                     
Elizabeth Baxter                                                      
Elizabeth.baxter@sanofi.com                                
T. +1 (0)908-981-5360                                             

TB Alliance
Derek Ambrosino
Derek.Ambrosino@tballiance.org
T. +1 (0)646-616-8639