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First Dengue Vaccine, Dengvaxia(R), Awarded 'The Vaccine Breakthrough of 2016' At the 6th Annual Biopharma Industry Awards Event In Singapore

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SINGAPORE, March 28, 2016 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi, is pleased to announce the company's dengue vaccine, Dengvaxia®, received the award for "The Vaccine Breakthrough of 2016" at the 6th annual Biopharma Industry Awards Event in Singapore.

The Biopharma Industry Awards recognize organizations and individuals for their significant contributions and achievements in Asia's burgeoning biologics industry, as well as for their passion to better shape the global biopharmaceutical operation value chain. The award for vaccine breakthrough of the year aims to promote the production of vaccines against prevalent diseases in Asia and recognise vaccines that address a critical medical need in Asia. Criteria for choosing the winner include innovative efforts towards developing novel drugs; efforts dedicated to disease prevention and treatment in Asia; contribution to improving public health outcomes in Asia and partnerships with NGOs and country governments to improve Asia community health programs.

"This award recognizes the innovation behind Dengvaxia®, the world's first dengue vaccine, that was developed in several endemic countries in Asia and is currently being introduced in the Philippines," says Joselito Sta Ana, Senior Director, Regional Head Dengue, Sanofi Pasteur Asia and Japan Pacific. "Dengvaxia® was developed in close collaboration with global, regional and local public health and dengue disease experts, as well as with the healthcare and local communities of dengue-endemic countries in Asia. The vaccine has the potential to be a real game changer for dengue prevention as part of an integrated approach to managing the considerable dengue burden here in Asia, which bears 70% of the global disease burden for this debilitating disease."

Sanofi Pasteur's dengue vaccine, Dengvaxia®, is the world's first vaccine licensed for the prevention of dengue caused by all four serotypes in individuals between nine and 45 years of age. To date, Dengvaxia® has received marketing approval in countries in both Latin America and Asia including Mexico, Brazil, El Salvador and the Philippines, after over two decades of research, development and clinical trials program involving over 40,000 people in 25 studies conducted in 15 countries around the world.

In the two large scale efficacy studies involving over 30,000 people from 10 endemic countries in Asia and Latin America, the Dengvaxia® vaccine documented efficacy (>65%) against all four serotypes of dengue. Furthermore, the vaccine's major clinical benefit is likely to stem from its proven efficacy to prevent 8 out of 10 dengue hospitalizations and up to approximately 93% of severe dengue including dengue hemorrhagic fever which can be fatal amongst study participants 9 years and older.

Based on national epidemiology surveillance in several dengue-endemic countries in both Asia and Latin America, up to 70 per cent of dengue cases occur globally in those older than 9 years of age[1]. The potential to reduce dengue incidence in this at-risk population through vaccination should have a significant impact also on the economic burden of dengue as they represent a highly mobile and social segment of the community in dengue-endemic countries who today contribute to the spread of the disease and the considerable loss of productivity due to dengue.

The 6th annual Biopharma Industry Awards were held in conjunction with BioPharma Asia Convention 2016, the leading industry platform for pharmaceutical companies, biotechnology companies, investors and other pharma stakeholders. Award recipients receive votes from members of Asia's life sciences community via a three-month-long nomination and voting process. Ultimately a panel of judges comprised of biopharma industry leaders select the winners among the nominees in each category.

This year, Dengvaxia® was chosen from among a prestigious list of nominees including GSK's Rotarix® and Rabipur®, CECMED's Heber-NASVAC and MSD's RotaTeq®.

About Dengvaxia®

Sanofi Pasteur's vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine. Dengvaxia® successfully completed phase III clinical studies in 2014 to evaluate the primary objective of vaccine efficacy[2],[3]

Dengvaxia® is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced at the dedicated production site in France with planned full-scale production capacity of 100 million vaccine doses annually.

Additional information about Sanofi Pasteur's dengue vaccine is available on the web at www.dengue.info.

[1]

Jackson N, et al. Recent scientific and clinical advances in Sanofi Pasteur's Dengue Vaccine Program. ASTMH 64th Annual Meeting October 25-29, 2015. Philadelphia, USA

[2]

Capeding M.R. et.al, Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial ; Volume 384, Issue 9951, 11–17 October 2014, Pages 1358–1365.

[3]

Villar L, Dayan GH, Arredondo-Garcia JL, Rivera DM, Cunha R, Deseda C et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med. 2015.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that match its areas of expertise and ensure a sustainable future. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

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 initiatives 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, 2015. 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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