GlobeNewswire Inc | Jul 31, 2020 07:00AM EDT

July 31, 2020

Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine

-- Promising vaccine candidate selected by U.S. governments Operation Warp Speed -- U.S. government to provide funding up to $2.1 billion for development, including clinical trials and manufacturing scale-up, and delivery of an initial 100 million doses -- Ongoing discussions with the European Commission, with France and Italy on the negotiation team, and other governments to ensure global access to a novel coronavirus vaccine

PARIS and LONDON July 31, 2020 Sanofi and GSK today announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine.

The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSKs established pandemic adjuvant technology.

Collaborating with the U.S. Department of Health and Human Services (HHS) and Department of Defense will help fund the development activities and secure scale-up of Sanofis and GSKs manufacturing capabilities in the United States for the recombinant protein-based, adjuvanted vaccine, resulting in a significant increase in capacity.

The U.S. government will provide up to $2.1 billion, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the U.S. government funding. The U.S. government has a further option for the supply of an additional 500 million doses longer term. This helps the U.S. governments Operation Warp Speed goals of providing millions of doses of a safe and effective COVID-19 vaccine.

The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone, said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. From the beginning of the pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis, collaborating with the U.S. Department of Health and Human Services to unlock a rapid path toward developing a pandemic vaccine and manufacturing at large scale. With our partner GSK, we expect our Phase 1/2 study for the recombinant adjuvanted approach to start in September.

Roger Connor, President of GSK Vaccines added, GSK is proud to be working in partnership with Sanofi to make this vaccine available at scale as soon as possible. We thank the U.S. government for playing a very important role in providing early, significant funding to enable the development and scale-up of this potentially important vaccine.

The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year, said HHS Secretary Alex Azar. Todays investment supports the Sanofi and GSK adjuvanted product all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.

Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, the companies can request U.S. regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally.

Sanofi and GSK are committed to making the vaccine available globally

Active discussions are ongoing with global organizations and with the EU Commission with France and Italy on the negotiation team on supplying European countries from Sanofis and GSKs European industrial network. The partners also plan to provide a significant portion of total worldwide available supply capacity in 2021/22 to the global initiative, Access to COVID19 Tools (ACT) Accelerator, a global collaboration of leaders of governments, global health organizations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

On the front lines in the fight against COVID-19

In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is also developing a messenger RNA vaccine candidate in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising. Sanofi expects a Phase 1 study to start by the end of the year, and, if the data are positive, an approval at the earliest in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally. For further information please visit www.gsk.com



About Sanofi

Sanofi is dedicated to supporting people through their health challenges. Weare a global biopharmaceutical company focused on human health. We preventillness with vaccines, provide innovative treatments to fight pain and easesuffering. We stand by the few who suffer from rare diseases and the millionswith long-term chronic conditions.

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

Sanofi, Empowering Life

Media Relations ContactsAshleigh KossTel.: +1 908-981-8745Ashleigh.Koss@sanofi.com Investor Relations Contact Eva Schaefer-Jansen Tel.: +33 (0)1 53 77 45 45Nicolas Kressmann ir@sanofi.comTel.: +1 732-532-5318Nicolas.Kressmann@sanofi.com

Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in thePrivate Securities Litigation Reform Act of 1995, as amended. Forward-lookingstatements are statements that are not historical facts. These statementsinclude projections and estimates and their underlying assumptions, statementsregarding plans, objectives, intentions and expectations with respect to futurefinancial results, events, operations, services, product development andpotential, and statements regarding future performance. Forward-lookingstatements are generally identified by the words ?expects?, ?anticipates?,?believes?, ?intends?, ?estimates?, ?plans? and similar expressions. AlthoughSanofi?s management believes that the expectations reflected in suchforward-looking statements are reasonable, investors are cautioned thatforward-looking information and statements are subject to various risks anduncertainties, many of which are difficult to predict and generally beyond thecontrol of Sanofi, that could cause actual results and developments to differmaterially from those expressed in, or implied or projected by, theforward-looking information and statements. These risks and uncertaintiesinclude among other things, the uncertainties inherent in research anddevelopment, future clinical data and analysis, including post marketing,decisions by regulatory authorities, such as the FDA or the EMA, regardingwhether and when to approve any drug, device or biological application that maybe filed for any such product candidates as well as their decisions regardinglabelling and other matters that could affect the availability or commercialpotential of such product candidates, the fact that product candidates ifapproved may not be commercially successful, the future approval and commercialsuccess of therapeutic alternatives, Sanofi?s ability to benefit from externalgrowth opportunities, to complete related transactions and/or obtain regulatoryclearances, risks associated with intellectual property and any related pendingor future litigation and the ultimate outcome of such litigation, trends inexchange rates and prevailing interest rates, volatile economic and marketconditions, cost containment initiatives and subsequent changes thereto, andthe impact that COVID-19 will have on us, our customers, suppliers, vendors,and other business partners, and the financial condition of any one of them, aswell as on our employees and on the global economy as a whole. Any materialeffect of COVID-19 on any of the foregoing could also adversely impact us. Thissituation is changing rapidly and additional impacts may arise of which we arenot currently aware and may exacerbate other previously identified risks. Therisks and uncertainties also include the uncertainties discussed or identifiedin the public filings with the SEC and the AMF made by Sanofi, including thoselisted under ?Risk Factors? and ?Cautionary Statement Regarding Forward-LookingStatements? in Sanofi?s annual report on Form 20-F for the year ended December31, 2019. Other than as required by applicable law, Sanofi does not undertakeany obligation to update or revise any forward-looking information orstatements.

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