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Inactivated Polio Vaccines Broadly Available for the World’s Children in the Drive toward Polio Eradication

Sanofi Pasteur works with global partners to make available unparalleled quantities of affordable Inactivated Polio Vaccine (IPV)

Lyon, France, – February 28, 2014, PRNewswire/– Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today its further commitment to the international community’s efforts to complete polio eradication. UNICEF, the organization that procures the vaccine to meet global needs, announced it will purchase significant quantities of Inactivated Polio Vaccine (IPV) from Sanofi Pasteur and make it available based on country needs and vaccination plans. To achieve the goal of polio eradication by 2018, the World Health Organization (WHO) recommends that by end 2015, all children receive routinely at least one dose of IPV in over 120 countries that solely use Oral Polio Vaccine.

In order to support rapid and widespread adoption of IPV, Sanofi Pasteur – the world’s largest producer of IPV – and the Bill & Melinda Gates Foundation have developed a joint price support mechanism, including a financial contribution from both organizations. This mechanism allows Sanofi Pasteur to offer IPV at a price of €0.75 per dose (approximately US$ 1) to 73 of the world’s poorest countries. The GAVI Alliance, a global immunisation partnership, will make IPV available for inclusion in routine immunisation schedules in these countries.

This announcement underscores Sanofi Pasteur’s commitment to offer unparalleled volumes of high-quality IPV across a broad range of countries and economic situations at differential prices in an unprecedented, global rollout.

“The World Health Organization welcomes today’s announcement to reduce the cost of this effective polio vaccine, it is a significant step forward in the fight against polio.” said Dr Margaret Chan, Director-General of WHO. “This development is a strong signal that polio eradication partners remain fully committed to a world without polio.”

“Reducing the price of IPV for the world’s poorest countries is helping remove the cost of the vaccine as a barrier to achieving a polio-free world. This is a significant advancement to ensure every child, no matter where they live, will benefit from access to this essential vaccine,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation.

“The people of Sanofi Pasteur are proud to help the world get rid of polio, as part of our public health mission,” said Olivier Charmeil, the CEO of Sanofi Pasteur. “Thanks to our longstanding commitment to polio eradication — in partnership with WHO, UNICEF, GAVI, CDC, Rotary International and the Bill & Melinda Gates Foundation — we are making it possible to finish the job,” he added.

“Today marks a big step forward in the global effort to tackle polio by accelerating the universal use of Inactivated Polio Vaccine,” said Dr Seth Berkley, CEO of the GAVI Alliance. “We expect the first countries will introduce IPV with GAVI support later this year. We are entering an exciting phase for polio and new efforts to strengthen routine immunisation which should see even more children benefit from the power of vaccines.”

The introduction of IPV, a vaccine that has been used in the majority of the developed world for years, in 120 countries is a necessary step toward achieving a polio-free world by 2018. The GPEI Endgame Strategic Plan 2013-2018, which was endorsed by 194 countries in 2013, offers a comprehensive roadmap that includes ending polio transmission, improving routine immunization rates and creating a lasting blueprint for addressing other significant global health challenges. Introducing at least one dose of IPV and switching progressively over the next few years from an oral polio vaccine (OPV) to IPV is critical to ending transmission and improving immunization rates. Because OPV contains a very weakened form of the live polio virus, the global plan calls for OPV to be progressively replaced with the inactivated, injectable vaccine as the world moves into the final stages of polio eradication.

Sanofi Pasteur committed to zero polio

Sanofi Pasteur has made significant investments in modern technology to produce very large quantities of IPV — up to 300 million doses a year. As well as this substantial investment in production capacity, Sanofi Pasteur support to IPV now includes development of a five-dose vial presentation (as well as the standard ten-dose vial presentation) to reduce wastage, a massive regulatory and licensing program in about 100 countries and expert contributions on scientific, program and technical questions.

Sanofi Pasteur, as a leader in providing both OPV and IPV, has been a partner of the Global Polio Eradication Initiative for over 20 years. The company has provided more than five billion doses of OPV to UNICEF over last two decades. In 1982, Sanofi Pasteur registered the first enhanced-potency inactivated polio vaccine (IPV), which is now distributed globally as a stand-alone poliovirus vaccine as well as in combination pediatric vaccines to immunize against many diseases in a single shot. Since then, Sanofi Pasteur has distributed more than 800 million doses of IPV and IPV-containing vaccines.

About Polio

According to the WHO, Polio (poliomyelitis) mainly affects children under five years of age. Polio is a highly infectious disease that spreads person to person. Approximately one in 200 people infected with polio will develop irreversible paralysis. Among those paralyzed, five to 10 percent die when their breathing muscles become immobilized.

Polio cases have decreased by over 99% since 1988, from an estimated 350 000 cases then, to 400 reported cases in 2013. The reduction is the result of the global effort to eradicate the disease. In 2014, only three countries (Afghanistan, Nigeria and Pakistan) remain polio-endemic, down from more than 125 in 1988. As long as a single child remains infected, under-immunized children in all countries are at risk of contracting polio. Estimates show that failure to eradicate polio from these last remaining strongholds could result in as many as 200,000 new cases worldwide every year, within 10 years. In most countries, the global effort has expanded capacities to tackle other infectious diseases by building effective surveillance and immunization systems.

About Sanofi

Sanofi, an integrated global 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).

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 offers the broadest range of vaccines protecting against 20 infectious diseases. 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 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts:

Global Media Relations
Alain Bernal
T. +33 4 37 37 50 38
alain.bernal@sanofipasteur.com

Sanofi Investor Relations Sébastien Martel
T. + 33 1 53 77 45 45
ir@sanofi.com
www.sanofipasteur.com

Images

Inactivated Polio Vaccine production (IPV), Marcy l'Etoile, June 2013, Copyright Sanofi Pasteur / Norbert Domy
Inactivated Polio Vaccine production (IPV), Marcy l'Etoile, June 2013, Copyright Sanofi Pasteur / Norbert Domy
Virus responsible for poliomyelitus (picornavirus), Copyright Sanofi Pasteur / Alain Grillet
Virus responsible for poliomyelitus (picornavirus), Copyright Sanofi Pasteur / Alain Grillet
Inactivated Polio Vaccine production (IPV), Marcy l'Etoile - May 2006, Copyright: Sanofi Pasteur  / Véronique Védrenne - Rights granted by the author until 2017/02/15
Inactivated Polio Vaccine production (IPV), Marcy l'Etoile - May 2006, Copyright: Sanofi Pasteur / Véronique Védrenne - Rights granted by the author until 2017/02/15
Electron microscope image of vero cells (balls of sephadex) for Inactivated Polio Vaccine production (IPV), Copyright Sanofi Pasteur / Alain Grillet
Electron microscope image of vero cells (balls of sephadex) for Inactivated Polio Vaccine production (IPV), Copyright Sanofi Pasteur / Alain Grillet
Ivory Coast – Africa, 2010/05, Copyright Sanofi Pasteur / Norbert Domy
Ivory Coast – Africa, 2010/05, Copyright Sanofi Pasteur / Norbert Domy

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