Moderna and ROVI Expand Long-term Collaboration for the Manufacture of MRNA Medicines Over the Next Ten Years

February 16, 2022 at 02:05 AM EST

Long-term agreement includes a series of investments to acquire new equipment and adapt the present ROVI drug product fill-finish facilities and production lines in Spain

CAMBRIDGE, MA and MADRID, SPAIN / ACCESSWIRE / February 16, 2022 / Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Laboratorios Farmacéuticos Rovi, S.A. (BME: ROVI), a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties, today announced a long-term collaboration to increase capacities for the compounding, aseptic filling, inspection, labeling, and packaging of ROVI's facilities, located in Madrid, San Sebastián de los Reyes and Alcalá de Henares.

This new agreement, which has a term of ten years, includes a series of investments expected to allow the manufacturing capacity to increase across ROVI's facilities in Madrid, Spain. In addition to producing Moderna's COVID-19 vaccine, ROVI's platform could also be utilized to service future Moderna mRNA vaccine candidates.

"ROVI has been a pivotal partner in supporting the manufacturing of our COVID-19 mRNA vaccine for countries outside of the U.S., and this long-term agreement expands our partnership and allows for further scale-up for future mRNA medicines," said Juan Andres, Moderna's Chief Technical Operations and Quality Officer.

Mr. Juan López-Belmonte Encina, ROVI's Chairman and Chief Executive Officer, said: "We are delighted to expand our collaboration with Moderna and become a long-term manufacturing partner. At ROVI, we are working to contribute all our experience as a high-technological-value contract manufacturer of injectables to the solution of this pandemic, and we are confident of our ability to take part in the manufacturing of new mRNA candidates in the future."

Moderna and Rovi are expected to finalize details of this agreement in the first quarter of 2022.

About Moderna

In 10 years since its inception, Moderna has transformed from a 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 seven 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. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

About ROVI

ROVI is a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and biological specialties. The company, in a continuous international expansion process, has subsidiaries in Portugal, Germany, the United Kingdom, Italy, France and Poland and has a diversified marketing portfolio of more than 40 products, among which its flagship product, Bemiparin, already marketed in 58 countries all over the world, should be highlighted. Likewise, in 2017, ROVI commenced the marketing in Europe of its in-house developed enoxaparin biosimilar. ROVI continues to develop the ISM® Platform technology, a leading-edge line of research in the field of prolonged drug release with proven advantages. For more information, please visit www.rovi.es.

Moderna's 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: Moderna's long-term collaboration with ROVI to increase capacities for the compounding, aseptic filling, inspection, labeling, and packaging, of ROVI's facilities in Madrid, Spain. 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 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 lings 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.

ROVI's Forward-looking Statements

This press release contains forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial performance or achievements of ROVI, or its industrial results, to be materially different to the future results, profitability or achievements expressed or implied in such forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that the manufacturing infrastructure required to expand capacity and capabilities in the manufacturing process of Moderna's COVID-19 vaccine is still being developed and implemented; potential adverse impacts due to the global COVID-19 pandemic, such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy. The statements in this press release represent ROVI's expectations and beliefs as of the date hereof. ROVI anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while ROVI may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ROVI's expectations or beliefs as of any date subsequent to the date of this press release.

Moderna

Media:
Luke Mircea Willats
Director, Corporate Communications
luke.mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

ROVI

Investors:
Marta Campos Martínez
+34 607 539 780
mcampos@rovi.es

Antonio Marquina Ospina
+34 674 315 715
amarquina@rovi.es

Media:
Beatriz García Suárez
+34 662 570 818
bgarciasuarez@rovi.es

SOURCE: Moderna, Inc.

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Moderna and ROVI Expand Long-term Collaboration for the Manufacture of MRNA Medicines Over the Next Ten Years

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