CDMO: EUROAPI supports Sanofi’s mRNA vaccine platform with the development of lipid nanoparticles

EUROAPI is a global leader in lipid nanoparticles with strong expertise in its Budapest and Frankfurt Development, Pilot and Manufacturing sites
Sanofi decided to expand its collaboration with EUROAPI to benefit from its specific expertise in both customed synthesis by complex chemistry and quality control by analytics
Lipid delivery systems are key enablers to ensure mRNA is properly delivered to the cell and represent a strategic component of mRNA vaccines

Paris – May 30, 2022 – EUROAPI (the “Company” or the “Group”) announces that it has expanded its collaboration with Sanofi under the umbrella of their Master Agreement for Development and GMP Manufacturing Services (the “DSA”), dated October 1, 2021, to support Sanofi’s mRNA vaccine platform with the development of lipid nanoparticles.

As part of this collaboration, EUROAPI will develop and optimize innovative chemical synthesis routes and manufacture GMP (Good Manufacturing Practices) batches for several second-generation cationic lipids through its Contract Development and Manufacturing Organization (CDMO) activity. As such, EUROAPI will focus on lipids that are currently being tested as part of Phase I/II clinical trials that will support Sanofi’s mRNA vaccines platform, targeting indications including Flu.

“We are delighted to announce the expansion of our agreement with Sanofi for mRNA vaccines development as part of our CDMO activity. This collaboration is key for EUROAPI as it further evidences EUROAPI’s capabilities as well as confirms that the acceleration of CDMO activity is a strategic priority for the Group. We are extremely proud to continue being a partner of choice for Sanofi and look forward to working together in this promising project” said Cécile Maupas, Chief CDMO Officer, EUROAPI.

“Our innovative and differentiated technologies coupled with our heritage in complex chemistry are providing a solid base for our next generation lipids CDMO offering which is currently expanding to other partners worldwide”, added Kai Rossen, Chief Scientific Officer, EUROAPI.

Through its CDMO activity, leveraged by strong capabilities in its Budapest and Frankfurt development and manufacturing sites, EUROAPI is a global leader in lipid nanoparticles which are the key delivery enabler technologies for mRNA vaccines. Lipid nanoparticles play a crucial role in their ability to encapsulate, protect and transport mRNA to the cells where it will exert its therapeutic activity.

EUROAPI will leverage its development and production capabilities in organic chemistry to provide Sanofi with clinical materials’ supply. With 330 scientists, EUROAPI benefits from unique expertise in complex chemistry, analytics and regulatory, enabling it to find the right synthesis pathway in a swift manner and meet health authorities’ regulatory and quality requirements. The Company is also equipped with state-of-the-art technology including large-scale chromatography purification equipment on its Budapest and Frankfurt sites that complies with the cGMPs (current Good Manufacturing Practices), allowing it to produce superior quality lipids.

EUROAPI is a CDMO partner of choice for Sanofi thanks to the signing of the DSA. EUROAPI is notably engaged in ten projects to develop and/or manufacture new molecular entities in the Sanofi’s R&D portfolio.

CDMO activity
The CDMO activity is a strategic priority for EUROAPI and is expected to reach ~35% of its total net sales by the end of 2025. It has already obtained promising results since the establishment of a dedicated CDMO business development team in 2021, with 26 new projects won at the end of January 2022 spanning from 10 projects in pre-clinical/Phase 1, 6 projects in Phase 2, 4 projects in Phase 3 and 6 projects at commercial stage.

About EUROAPI

EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.
Taking action for health by enabling access to essential therapies inspires our 3,350 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext. Find out more at www.euroapi.com

Media Relations Contact:

Laurence Bollack
Mob.: +33 (0)6 81 86 80 19
mr@euroapi.com

Investor Relations Contact:

Guillaume Rosso
Mob.: +33 (0)6 49 51 59 78
ir@euroapi.com

Forward-Looking Statements
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors relating to the issuer” of the prospectus approved by the French Financial Markets Authority (Autorité des marchés financiers, AMF) on March 31, 2022, under number 22-076. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.