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Sanofi Pasteur uses novel technology for development of a 2nd-gen influenza vaccine

March 29, 2016

Lyon, France - March 29, 2016 - Sanofi Pasteur, the vaccines division of Sanofi, announces published data on a vaccine strategy that elicited a broadly-reactive response against seasonal and pandemic H1N1 influenza viruses in mice. The article, entitled "Design and characterization of a computationally optimized broadly reactive hemagglutinin vaccine for H1N1 influenza viruses," appears in the current issue of the Journal of Virology. Sanofi Pasteur has an R&D collaboration agreement with the University of Georgia and representatives of both organizations will be presenting the data tomorrow, March 30, at the 2016 World Vaccine Congress being held in Washington, D.C.

Previously, a novel hemagglutinin (HA) for H5N1 influenza was derived using a methodology termed computationally optimized broadly reactive antigen (COBRA). This COBRA HA elicited a broad antibody response against H5N1 isolates from different clades in mice and nonhuman primates. In this new publication, the authors present pre-clinical efficacy data demonstrating that COBRA technology can be extended to elicit antibodies against many drifted H1 strains and has the potential to be used in the development of a "subtype universal" vaccine. According to the authors, "One of the challenges of developing next generation influenza A vaccines is the diversity of antigenically distinct isolates. We now report the characterization of a COBRA-based vaccine for both seasonal and pandemic H1N1 influenza isolates."

As described in the publication, nine HA COBRA candidates were designed and assessed as vaccines used alone, in cocktails, or in prime-boost combinations. The most effective regimens elicited the broadest hemagglutination-inhibition (HAI) response against a panel of H1N1 viruses isolated over the past 100 years - even against viruses whose sequences were not included in the design strategy. This study represents the first demonstration of a COBRA-based HA vaccine strategy that elicits a broadly-reactive response against both seasonal and pandemic H1N1 isolates.

Sanofi Pasteur has an existing R&D collaboration agreement with the University of Georgia to further design and develop novel synthetic vaccines based on the HA protein to help protect against disease caused by seasonal influenza strains spanning several years, including drifted strains not yet in existence. This would provide an advantage over traditional influenza vaccine manufacturing, which depends on the selection of candidate vaccine viruses by public health authorities following analysis of data collected through active surveillance of influenza viruses circulating each year.

"This experimental and novel vaccine is generated from the sequences of many flu viruses and is designed to help protect against many strains over several years," explained Tim Alefantis, PhD, MBA, Sanofi Pasteur's R&D lead on the 2nd generation vaccine program and one of the authors of the published findings. "The key advantage could be broader coverage against several seasonal flu strains." He added, "An additional advantage of this approach is that it doesn't rely upon annual strain selection, allowing year-round manufacturing."

According to the publication, "Universal influenza vaccine approaches have the potential to be paradigm-shifting for the influenza vaccine field, with the goal of replacing current, standard-of-care seasonal vaccines with broadly cross-protective vaccines." However, Sanofi Pasteur Senior Vice President for R&D, John Shiver, PhD, says, "While a truly universal vaccine is the ultimate goal, we believe that a broader-spectrum vaccine could be available first to replace the current seasonal flu vaccine given annually."
A full version of the paper is available at

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 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: or

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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