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Sanofi Grants Regeneron Exclusive Worldwide License Rights to Libtayo® (cemiplimab)

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Sanofi to agrees Regeneron’s exclusive worldwide license rights to Libtayo® (cemiplimab)

  • Sanofi will receive an upfront payment of $900 million and an 11% royalty on worldwide net sales of Libtayo
  • Sanofi will also be entitled to a regulatory milestone payment of $100 million as well as sales milestone payments of up to $100 million over the next two years.

Paris, June 2, 2022. Sanofi is restructuring its immuno-oncology collaboration with Regeneron Pharmaceuticals, Inc. Under the amended and restated license and collaboration agreement, Regeneron will obtain exclusive worldwide licensing rights to Libtayo. The worldwide licensing and collaboration agreement between Sanofi and Regeneron in immuno-oncology has been originally realized in 2015. Prior to today, the companies had equally shared Libtayo’s worldwide operating profits and co-marketed Libtayo in the United States, with Sanofi being solely responsible for marketing in the rest of the world.

Bill SiboldExecutive Vice President of Specialty Care and President of North America, SanofiOur Diversified Oncology Portfolio double between 2019 and 2022 and now understands Twelve compounds in clinical trialseach with a unique mechanism of action. Our first steps with Libtayo in immunityoh-oncology provided a strong foundation for our revitalized oncology efforts. Now, we focus on leverageaging our internal capacities and advancing a new generation of oncology medications. We continue to maintain a strong partnership with Regeneron in immunology, and will work closely with them on transparent transition of Libtayo to ensure there is no impact to patients.”

Under the terms of the Amended and Restated Immuno-Oncology License and Collaboration Agreement, Sanofi will transfer all development, marketing and manufacturing rights of Libtayo to Regeneron, on a worldwide basis, for a defined transition period (beginning on receipt of all required government clearances worldwide). In exchange, Sanofi will receive an upfront payment of $900 million and an 11% royalty on Libtayo’s global net sales. Sanofi will also be eligible for a $100 million regulatory milestone payment upon first FDA or European Commission approval of Libtayo in combination with chemotherapy for the first-line treatment of certain patients with NSCLC, as well as to sales-related milestone payments of up to $100 million in total over the next two years. The transaction is subject to clearance under competition law and is expected to close in the third quarter of 2022.

Regeneron will also expedite repayment of the development balance associated with Regeneron and Sanofi’s separate Antibody collaboration. Regeneron will increase the share of its profits that is paid to Sanofi to reimburse Sanofi-funded development expenses from 10% to 20%, until Regeneron’s share of the total cumulative development costs incurred under the collaboration has been achieved.

Sanofi continues to develop its considerable expertise in oncology and has increased its research and development capabilities, focusing on hard-to-treat cancers, including breast, blood and lung. We are committed to translating scientific discoveries into potential new treatments and closing critical gaps in cancer care.

About SanofiWe are an innovative global healthcare company driven by one purpose: we pursue the miracles of science to improve people’s lives. Our team, present in over 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially game-changing treatment options and life-saving vaccine protection to millions of people around the world, while placing sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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Disclaimer or Forward-Looking StatementsThis 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 regarding future financial results, events, operations, services, development and potential of products, 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 these 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 Sanofi’s control. , which could cause actual results and developments to differ materially from those expressed, implied or projected by the forward-looking information and statements. These risks and uncertainties include, among others, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing, decisions of regulatory authorities, such as the FDA or EMA, regarding the whether and when to approve any drug, device or biologic that may be filed for these product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of these product candidates, the fact that the product candidates, if approved, may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to enter into related transactions and/or obtain regulatory approvals, intellectual property risks and any pending litigation or future partner and the ultimate outcome of such litigation, prevailing exchange rate and interest rate trends, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors and other business partners, and the financial condition of any of them, as well as on our employees and on the global economy as a whole. together. Any material effect of COVID-19 on any of the above may also adversely impact us. This situation is changing rapidly and additional impacts may arise that we are not currently aware of and may exacerbate other previously identified risks. Risks and uncertainties also include uncertainties discussed or identified in public filings with the SEC and AMF by Sanofi, including those listed under “Risk Factors” and “Caution Regarding Forward-Looking Statements” in the Sanofi’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021. Except as required by applicable law, Sanofi undertakes no obligation to update or revise any forward-looking information or statements.

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Source: Sanofi-Aventis Group