GlobeNewswire Inc | Jul 29, 2020 01:00AM EDT

July 29, 2020



Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine

-- Agreement relates to vaccine candidate using Sanofis recombinant protein-based technology combined with GSKs pandemic adjuvant system -- Both companies are committed to making their COVID-19 vaccine candidate affordable and available globally -- 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 29, 2020 Sanofi and GSK have reached an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 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.

With our partner GSK, we are pleased to cooperate with the UK government as well as several other countries and global organizations as part of our ongoing efforts to develop a safe and effective vaccine and make it available as quickly as possible. We greatly appreciate the UK governments support of this shared vision, said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

Roger Connor, President of GSK Vaccines added, "We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world. We thank the UK Government for confirmation of purchasing intent, which supports the significant investment we are already making as a company to scale up development and production of this vaccine.

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, regulatory approval could be achieved by 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 overall.

UK Business Secretary Alok Sharma said:Our scientists and researchers are racing to find a safe and effective vaccine at a speed and scale never seen before. While this progress is truly remarkable, the fact remains that there are no guarantees.

In the meantime, it is important that we secure early access to a diverse range of promising vaccine candidates, like GSK and Sanofi, to increase our chances of finding one that works so we can protect the public and save lives.

Kate Bingham, Chair of the UK Governments Vaccines Taskforce, said:Through this agreement with GSK and Sanofi, the Vaccine Taskforce can add another type of vaccine to the three different types of vaccine we have already secured.

This diversity of vaccine types is important because we do not yet know which, if any, of the different types of vaccine will prove to generate a safe and protective response to COVID-19.Whilst this agreement is very good news, we mustnt be complacent or over optimistic.

The fact remains we may never get a vaccine and if we do get one, we have to be prepared that it may not be a vaccine which prevents getting the virus, but rather one that reduces symptoms.

Sanofi and GSK are committed to making the vaccine available globally

Active discussions on supply of the vaccine are ongoing with global organizations, the U.S. and the EU Commission, with France and Italy on the negotiation team. The partners 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 ContactAshleigh 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.



Attachment

-- Press release