First Doses of Injectable Polio Vaccine ShanIPV(TM) Soon Available for Indian Infants

- This new polio vaccine is manufactured by Shantha in Hyderabad, India -

- Both Sanofi Pasteur and Shantha are to provide the majority of doses for the introduction of IPV in India, a key step towards polio eradication -

Lyon, France - November 30, 2015 - Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first shipment of ShanIPV(TM), a brand new injectable, inactivated polio vaccine (IPV) manufactured by its affiliate Shantha Biotechnics, in Hyderabad, India, will occur in a couple of days. These first vaccine doses will be available to implement one dose of IPV in India's immunization schedule for all infants.

Today, India is officially introducing IPV in their national immunization schedule, to supplement the iconic "drops on sugar" of oral polio vaccine (OPV). Over 20 million newborns will eventually benefit from this new vaccine every year. This is a critical step towards a polio-free future, a prospect that is now very close. India's 2014 certification as polio-free reassured experts that the decades-long global fight against polio was finally drawing to an end. Sanofi Pasteur and its affiliate Shantha Biotechnics will together produce most of India's IPV supply.

"With the introduction of IPV in their immunization schedule, India moves the world much closer to being polio-free", said Olivier Charmeil, President and CEO of Sanofi Pasteur. "As a company deeply rooted in India, we are very proud that vaccines produced by both Sanofi Pasteur and Shantha will be used in this vital step towards a polio-free world. We have worked as partners of the government of India for many years, with this day in mind."

Only two countries in the world are still classified as polio endemic, meaning that wild polio virus passes routinely between members of the community. However, great progress has been made in both countries and the last case of polio in the world may possibly be only months away. "Ours will be the last generation to see the horror of children paralyzed or killed by polio. I am sure," said Pr Jacob John (Former Christian Medical College, Vellore, Tamil Nadu, India). "Maybe we will remember 2015 as the year we took the final step to eradicate this disease forever."

About Oral and Injectable Polio Vaccines
OPV has been instrumental in ending polio cases in India and has been used across the world to reduce the number of cases of polio by over 99 percent in the past twenty years. Today, the World Health Organization (WHO) recommends that the live OPV be supplemented and then replaced by an inactivated IPV. OPV and IPV stimulate the body's immune system in slightly different ways so children who receive both should be even better protected against the disease.

When the world is polio-free, IPV will be the only vaccine used to make sure that the disease never comes back, according to a 2012 WHO policy. OPV contains a mixture of live attenuated poliovirus strains. Although OPV is safe it is not advisable to be used after achieving a polio-free status: when polio no longer exists in the wild, live virus cannot still exist in a vaccine.

The universal introduction of IPV, a vaccine that has been used in many countries of the world for years, is a necessary step towards achieving a polio-free world by 2019 according to the Global Polio Eradication Initiative (GPEI) Endgame Strategic Plan. Today, more than 110 countries have introduced IPV in their immunization calendars.

Sanofi Pasteur committed to a polio-free world
In February 2014, Sanofi Pasteur - the world's largest producer of IPV - and the Bill & Melinda Gates Foundation announced a joint price support mechanism, including a financial contribution from both organizations. The mechanism allows Gavi to make IPV available for inclusion in the routine immunization schedules in 73 of the world's poorest countries.

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 one billion doses of IPV and IPV-containing vaccines.

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:
http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx) and in New York (NYSE: SNY:
http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx).

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 a broad 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:
http://www.sanofipasteur.com/ or www.sanofipasteur.us:
http://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, 2014. 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 Pasteur Media Relations 
Alain Bernal
T. +33-4-37-37-50-38
alain.bernal@sanofipasteur.com:
mailto:alain.bernal@sanofipasteur.com
www.sanofipasteur.com:
http://www.sanofipasteur.com/
Sanofi India Media Relations 
Aparna Thomas
T. +91 22 2803 2169
aparna.thomas@sanofi.com:
mailto:aparna.thomas@sanofi.com
www.sanofi.in:
http://www.sanofi.in
 

 
Investor Relations
Sébastien Martel 
T. + 33 1 53 77 45 45
ir@sanofi.com:
mailto:ir@sanofi.com
 
Press release (PDF):
http://hugin.info/152918/R/1969988/720137.pdf



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Source: Sanofi via Globenewswire

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