Jul 1, 2021   SOURCE: BusinessWire

Moderna Announces Recipharm Site in France Manufacturing COVID-19 Vaccine Moderna Following Approval by European Medicines Agency

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Recipharm (STO: RECI-B), a leading contract development and manufacturing organization (CDMO), today confirmed that following the European Medicines Agency’s (EMA) Committee for Human Medicines (CHMP) approval of the Recipharm Monts site on June 11, 2021, drug product manufacture of the Moderna COVID-19 vaccine at the site in France has now begun.

“We are proud to be working with Recipharm to build industrial production capacity in France in support of Europe’s vaccination campaign,” said Stephane Bancel, Chief Executive Officer of Moderna. “France is at the heart of European innovation in healthcare and will play an important role in Moderna’s strategic growth plan.”

“Our collaboration with Moderna has created a strong foundation for vaccine production in France, leveraging our manufacturing excellence to ensure the timely delivery of the Moderna COVID-19 vaccine to Europe,” said Marc Funk, CEO of Recipharm.

Moderna’s partnership with Recipharm is reflective of the Company’s commitment to expanding its global manufacturing capacity. Investments made earlier this year are expected to enable a doubling of drug substance manufacturing in Europe. When completed, the investments are expected to also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.

Authorized Use

The European Commission granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

About the COVID-19 Vaccine Moderna

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in 49 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO). Moderna has filed for emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adolescents with health agencies in the European Union, Canada, the U.S., Switzerland and Japan.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 14 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company’s development of a vaccine to protect against the SARS-CoV-2 virus (mRNA-1273, also referred to as COVID-19 Vaccine Moderna and the Moderna COVID-19 Vaccine); and the Company’s agreement with Recipharm to increase drug product manufacturing for the vaccine from French production sites. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.