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Dec. 9, 2019, 8:30 a.m. EST

Sanofi awarded $226 million by US government to expand pandemic influenza preparedness

- U.S.-based, state of the art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic

SWIFTWATER, Pa., Dec. 9, 2019 /PRNewswire/ -- Sanofi Pasteur, the vaccines global business unit of Sanofi, has entered into an agreement with the U.S. Department of Health and Human Services (HHS) to increase the company's domestic pandemic influenza vaccine production capabilities based in Swiftwater, Pennsylvania.

The contract is supported by federal funds from the Biomedical Advance Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS.

"We are pleased to be taking this critical next step in our longstanding relationship with BARDA, which will enable us to significantly enhance flu vaccine supply under pandemic influenza scenarios," said David Loew, Executive Vice President, Vaccines at Sanofi. "We are deeply committed to advancing influenza vaccine technology and manufacturing, and our public and private partnerships are an important part of these ongoing efforts to help protect people from influenza."

"The question is not if, but when the next influenza pandemic will occur, carrying potentially devastating consequences for public health and the U.S. economy," said BARDA Director Rick Bright, Ph.D. "As the recent presidential executive order on pandemic preparedness emphasized, technology to produce effective vaccines quickly and safely in the United States can improve access, protect more people sooner and, ultimately, strengthen national and global health security. Public-private partnerships, such as this one with Sanofi Pasteur, are essential in moving such technology forward."

The contract will support the clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine to help enhance U.S. and global pandemic preparedness.  This investigational pandemic vaccine will utilize the same recombinant technology as Sanofi's Flublok [® ] Quadrivalent (influenza vaccine). In addition, the contract will expand the site's role as a center of excellence for pandemic preparedness by adding both recombinant and adjuvant manufacturing alongside current egg-based manufacturing.

Flublok Quadrivalent is indicated for adults 18 years of age and older and proven in a randomized controlled trial to help prevent 30 to 43 percent more cases of laboratory-confirmed influenza in people 50 years of age and older compared to a standard-dose quadrivalent inactivated influenza vaccine. [i] Flublok Quadrivalent is the only recombinant protein-based influenza vaccine approved by the U.S. Food and Drug Administration (FDA), uniquely providing an exact genetic match of hemagglutinin (HA) from each recommended vaccine virus. HA is the protein identified as key to stimulating immunity to influenza.

What is Flublok® Quadrivalent (Influenza Vaccine)? Flublok Quadrivalent is a vaccine indicated for the prevention of influenza disease caused by influenza A and B strains contained in the vaccine. Flublok Quadrivalent is given to people 18 years of age and older.

IMPORTANT SAFETY INFORMATION FOR FLUBLOK® QUADRIVALENT (INFLUENZA VACCINE) Flublok Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine or after previous dose of the vaccine.

Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.

If Flublok Quadrivalent is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Vaccination with Flublok Quadrivalent may not protect all people who receive the vaccine. For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. In adults 50 years of age and older, the most common side effects were tenderness, and/or pain where you got the shot; headache, and tiredness. Other side effects may occur.

Before administration, please see the full Prescribing Information for Flublok Quadrivalent .

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We help prevent illness with vaccines, provide innovative treatments to fight pain, and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Media Relations ContactNicolas Kressmann Tel.: +1 732-532-5318Nicolas.Kressmann@sanofi.com Investor Relations ContactGeorge GrofikTel.: +33 (0)1 53 77 45 45ir@sanofi.com

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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks 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, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

[i]  Flublok Quadrivalent PI. [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. https://www.vaccineshoppe.com/image.cfm?doc_id=14672&image_type=product_pdf .

Source: Sanofi /zigman2/quotes/206928357/delayed FR:SAN +0.96% /zigman2/quotes/201967021/composite SNY -1.95%

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SOURCE Sanofi

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