Sanofi Pasteur’s Dengue Vaccine Approved in Indonesia
- Indonesia is the 7th country in the world to approve the dengue vaccine, which was recently endorsed by the World Health Organization (WHO) supporting the safety, efficacy and public health value of the dengue vaccine for use in endemic countries -
- Vaccine needed to address precipitous rise of dengue in Indonesia, with greater than 39%i increase in incidence in 2016 already compared to last year's numbers -

Jakarta, Indonesia – 13 September, 2016 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that Indonesia’s National Agency for Drug and Food Control has approved Sanofi Pasteur’s tetravalent dengue vaccine, to protect individuals living in endemic areas against all four serotypes of dengue.

The approval in Indonesia is the second registration of the dengue vaccine in Asia, and the seventh in the world. Sanofi Pasteur’s dengue vaccine has already been approved in Mexico, Brazil, El Salvador, Costa Rica, the Philippines and Paraguay.

“We welcome the timely approval of the dengue vaccine in Indonesia,” said Professor Dr. Sri Rezeki S. Hadinegoro, Chairman of ITAGI (Indonesian Technical Advisory Group on Immunization), “The dengue disease is hyper-endemic in our country and already in April 2016, more than 80,000 dengue cases were recorded which is a 39%ii spike vis-à-vis levels in 2015. Indonesia has one of the world’s highest dengue burden costing us more than USD323 million annually,iii and approval of the dengue vaccine gives us access to this innovative prevention tool to curb further spread of this debilitating disease and strengthen Indonesia’s dengue control strategy for the future.”

The WHO published its position paper on dengue vaccine use on 29 July 2016 in which it recommended endemic countries to consider the introduction of Sanofi Pasteur’s dengue vaccine as part of integrated disease prevention including vector control and community mobilization.iv The WHO has set the objectives of reducing mortality by dengue by 50% and morbidity by 25% by 2020 in the endemic countries.v

“Dengue represents a growing and serious public health issue in many parts of Asia with significant associated human and economic burden,” according to Dr. Anh Wartel, Medical Affairs, Sanofi Pasteur Asia & Japan Pacific. “This latest approval in Indonesia, the second in Asia, is testament to the speed which we are moving to make dengue a vaccine-preventable disease in countries where the disease burden is the highest. This is important as 70% of the world’s population at risk of dengue lives in Asia, and healthcare providers in Indonesia now have access to the first clinical preventive tool which allows them to better protect their people against this public health threat.”

Severe dengue, or dengue haemorrhagic fever, was first recognized in Indonesia in the cities of Jakarta and Surabaya in 1968. Between 2004 and 2010, Indonesia reported the second highest number of dengue cases in the world behind Brazil according to the World Health Organization, with an average of 129,000 cases per year.vi Nevertheless, dengue reporting in the country is acknowledged to be incomplete and the efficacy of reporting procedures varies widely among the provinces. A 2013 cartographical modelling study estimated that as many as 7.6 million dengue infections may have occurred in the country in 2010 with the vast majority going unreported.vii In 2015, the number of reported cases rose to just over 100,000 and 907 deaths were attributed to dengue.viii

The global burden of dengue

According to the WHO, dengue is currently the fastest-growing mosquito-transmitted disease in the world, causing around 400 million infections every year. Over the last 50 years, dengue has spread; initially present in a handful of countries, it is now endemic in 128, inhabited by around 4 billion people. Also, the incidence of this disease has increased 30 times in this same period.ix

Even though dengue affects people of all ages and lifestyles, the greatest number of dengue cases worldwide occurs in individuals 9 years of age and older, who represent a highly mobile and social segment of the community capable of contributing significantly to spread of the disease.xxi

About Sanofi Pasteur’s dengue vaccine

In addition to Indonesia, Sanofi Pasteur Dengue Vaccine is also registered in Mexico, Brazil, El Salvador, Costa Rica, The Philippines and Paraguay to date. Regulatory review processes for Dengue Vaccine are continuing in other countries where dengue is a public health priority.

Sanofi Pasteur’s dengue vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in over 15 countries around the world. More than 40,000 volunteers participated in the dengue vaccine clinical study program (phase I, II and III), of whom 29,000 volunteers received the vaccine.xii

A summary of the efficacy documentation on Dengvaxia® for the study population 9 years and older population was published in The New England Journal of Medicine on July 27th 2015. These findings affirm the vaccine’s consistent efficacy in reducing dengue due to all four serotypes in two thirds of the study participants 9 years and older and also documents the ability of the vaccine to prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases in this age group during the 25 month follow-up phase of the studies.xiii

An integrated safety analysis was recently published documenting Dengvaxia®’s satisfactory safety profile comparable to placebo during the late stage clinical study program involving around 30,000 participants from 15 countries. In addition, the results of this analysis documented that the vaccine provided beneficial protection against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination compared to placebo in the study population 9 years and older.xiv

Sanofi Pasteur Dengue Vaccine is the first vaccine licensed for the prevention of dengue in the world. The vaccine is supplied from a dedicated production site in France.

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

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. 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 provides a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. 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, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, 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.


i Arbovirus Subdit CDC Indonesia MOH, April 2016

ii Arbovirus Subdit CDC Indonesia MOH, April 2016

iii Shephard D et al (2013). Economic and Disease Burden of Dengue in Southeast Asia. Retrieved from US National Library of Medicine National Institutes of Health. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578748/ [Last accessed: 15 August 2016]

iv World Health Organization. Dengue vaccine: WHO position paper – July 2016 http://www.who.int/wer/2016/wer9130.pdf?ua=1 [Last accessed: 15 August 2016]

v World Health Organization. Global strategy for dengue prevention control 2012-2020. Geneva: WHO, 2012. http://apps.who.int/iris/bitstream/10665/75303/1/9789241504034_eng.pdf. [Last accessed: 15 August 2016]

vi World Health Organization. (2012) Global Strategy for Dengue Prevention Control. 2012-2020. http://apps.who.int/iris/bitstream/10665/75303/1/9789241504034_eng.pdf?ua=1 [Last accessed: 2 June 2016]

vii Bhatt, S. et al (2013). The global distribution and burden of dengue. Nature 496, 504-7.

viii Jakarta Post, Severe Dengue Spreads Across Regions, Claims Lives. (25 Feb 2016). http://www.thejakartapost.com/news/2016/02/25/severe-dengue-spreads-across-regions-claims-lives.html [Last accessed: 15 August 2016]

ix World Health Organization. Dengue and severe dengue. Factsheet No 117 http://www.who.int/mediacentre/factsheets/fs117/en/ html [Last accessed: 15 August 2016]

x Egger JR. Age and clinical dengue illness. Emerg Infect Dis. 2007;13:924-5

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xii Capeding MR, et al. Lancet 2014;384:1358-65

xiii Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206

xiv Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: pooled analysis of data from 18 clinical trials.Gailhardou et al PLoS Negl Trop Dis. 2016 Jul 14;10(7):e0004821. doi: 10.1371/journal.pntd.0004821