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Sanofi Pasteur’s quadrivalent influenza vaccine now available for the 2017-2018 influenza season

The UK is the first European country to market Sanofi Pasteur’s four-strain influenza vaccine, helping provide broad protection for people aged over three years old


Maidenhead, United Kingdom, September 12, 2017– Sanofi Pasteur, the vaccines division of Sanofi, announced today that, for the first time, it is making available its quadrivalent influenza vaccine in the UK. The United Kingdom (UK) is the first European country to market Sanofi Pasteur’s quadrivalent influenza vaccine.

Flu is an unpredictable virus which can lead to serious complications, hospitalisation, and in some cases even fatalities, especially for those in at risk patient groups and in particular those above 65 years as well as those with chronic diseases like asthma, heart disease and diabetes,” said Dr Ian Gray, Medical Head, Sanofi Pasteur UK & Ireland. “The UK authorities are leading the way in Europe by encouraging those in at risk groups to get vaccinated against flu. Sanofi Pasteur fully supports such immunisation policies by developing innovative vaccines that fit with the influenza epidemiology, providing the option for broad protection for those aged 3 years and older.

Currently, the majority of seasonal influenza vaccines are trivalent, meaning that they protect against three strains of influenza virus: two A strains and one single B strain. However, over the recent flu seasons, co-circulation of two B strains has been consistently observed. For example, in 2015 92% of documented B strain-related cases of influenza reported in Europe were caused by a B strain which was not included in the available trivalent vaccines during that season1 . The quadrivalent influenza vaccines include both B strains. By adding protection against the additional B strain, these innovative vaccines help address the unpredictable nature of B strain circulation, thus broadening protection against influenza.

Sanofi Pasteur’s quadrivalent influenza vaccine obtained its marketing authorisation in the European Union in June 2016 and in the UK later that year. It is now available in the UK in addition to the current influenza vaccines.
Hugo Fry, General Manager of Sanofi Pasteur UK & Ireland explains, “Sanofi Pasteur, the world’s largest manufacturer of influenza vaccines, remains at the forefront of innovation to fight the known burden of influenza. Over the next few years our vaccine portfolio will evolve further and Sanofi Pasteur will continue to support public health needs”.

About quadrivalent influenza vaccines
WHO includes quadrivalent influenza vaccines in its recommendations, stating “Quadrivalent influenza vaccines that could potentially provide wider protection against influenza B viruses are becoming available and recommendations should not be limited to trivalent vaccine.” From a public health perspective, using quadrivalent rather than trivalent influenza vaccines could have resulted in a further reduction of up to 1.6 million influenza cases, 37,300 influenza-related hospitalisations and 14,800 influenza-related deaths in the EU over a decade.2

About influenza
Seasonal influenza or “flu” is an acute viral infection caused by influenza viruses, spreading easily from person to person and circulating year-round worldwide. Seasonal influenza is characterised by a sudden onset of fever, cough (usually dry), headache, muscle and joint pain, severe malaise (feeling unwell), sore throat and a nasal discharge. The cough can be severe and can last 2 or more weeks. Most people recover from the fever and other symptoms within a week without requiring medical attention. However, influenza can cause severe illness or fatalities especially in those at high risk. The highest risk of complications occur among pregnant women, children aged 6–59 months, the elderly, individuals with specific chronic medical conditions (such as HIV/AIDS, asthma, and heart or lung diseases), and healthcare workers.3
According to the World Health Organization’s (WHO) estimates, the influenza annual global attack rates are estimated at 5-10% in adults and 20–30% in children4. Worldwide, annual influenza epidemics result in three to five million cases of severe illness, and 250,000 to 500,000 deaths5. In the UK, deaths attributable to flu are estimated to range from around 4,000 to 14,000 per year, with an average of around 8,000 per year.6

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 Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than one billion doses of vaccine each year, making it possible to immunise 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 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 world’s largest manufacturer of influenza vaccines. In 2016, Sanofi Pasteur confirmed its leadership by completing a production of 200 million doses of seasonal influenza vaccine, i.e. approximately 40% of influenza vaccines distributed worldwide.

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, 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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

1. ECDC. Seasonal influenza vaccination and antiviral use in Europe – Overview of vaccination recommendations and coverage rates in the EU Member States for the 2013–14 and 2014–15 influenza seasons. Stockholm: ECDC; 2016. http://ecdc.europa.eu/en/publications/publications/seasonal-influenza-vaccination-antiviral-useeurope.pdf
2. Uhart M, et al. Public health and economic impact of seasonal influenza vaccination with quadrivalent influenza vaccines compared to trivalent influenza vaccines in Europe. Hum Vaccin Immunother. 2016 11:1-10.
3. WHO fact sheet dated Nov. 2016 - http://www.who.int/mediacentre/factsheets/fs211/en/
4. WHO. Weekly epidemiological record - Vaccines against influenza WHO position paper, 87, No. 47 p461–476. November 23, 2012. Available at: http://www.who.int/wer/2012/wer8747/en/
5. WHO Influenza Factsheet: Influenza (Seasonal). http://www.who.int/mediacentre/factsheets/fs211/en/
6. Public Health England. Public Health England and the NHS Prepare for Unpredictable Flu Season. Available at: https://www.gov.uk/government/news/publichealth-england-and-the-nhs-prepare-forunpredictable-flu-season. Last accessed August 2017.

Date of preparation: September 2017 - Job bag number: SAGB.IFLU.17.09.1107

Updated: September 12, 2017

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