Recipharm and Moderna finalize agreement for aseptic drug product manufacturing and fill-finish for supply to countries outside the U.S.
(Cambridge, Mass. and Stockholm, Sweden) – Dec. 30, 2020 - Moderna, Inc. (NASDAQ:MRNA), biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Recipharm (STO: RECI-B), a leading contract development and manufacturing organization (CDMO), today announced that they have reached an agreement to support formulation and fill-finish a part of the Moderna COVID-19 vaccine supply outside of the U.S. The activity will be performed in Recipharm’s drug product manufacturing facility located in France.
Subject to regulatory approval of the vaccine in relevant countries outside of the U.S., it is anticipated that supply will commence in early 2021.
“We are making important progress in the development of the Moderna COVID-19 vaccine and we are pleased to be entering into this collaboration with Recipharm,” said Nicolas Chornet, Senior Vice President, International Manufacturing of Moderna. “We look forward to their support in the delivery of our vaccine to market.”
“This is a material and strategically important agreement for us, and we are delighted to be working with Moderna on such a vital project to support the long-term fight against COVID-19,” said Thomas Eldered, CEO of Recipharm. “Our preparations are already well underway with the hiring of new staff and investment in the facility to enable us to meet the challenging timelines.”
Thomas Eldered, CEO, telephone: +46 8 602 52 10
Jean-François Hilaire, Executive Vice President, telephone: +33 695 447 507
Tobias Hägglöv, CFO, firstname.lastname@example.org, telephone: +46 8 602 52 00
Media: Colleen Hussey, Director, Corporate Communications, telephone: +1 617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar, Senior Vice President & Head of Investor Relations, telephone: +1 617-209-5834 Lavina.Talukdar@modernatx.com
This is information that Recipharm AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 17:20 CET on 30 December 2020.
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing almost 9,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, pharmaceutical product development and development and manufacturing of medical devices. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s annual turnover is approximately SEK 11 billion. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.
For more information on Recipharm and our services, please visit www.recipharm.com
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the terms of the collaboration between Recipharm and Moderna for the formulation, filling and finishing of pharmaceutical products, including the Moderna COVID-19 vaccine, and the timing for commencement of supply of the vaccine. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna’s regulatory approval strategies, components of the company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties listed under the heading “Risk Factors” in Moderna’s most recent quarterly report on Form 10-Q filed with the SEC and in subsequent filings made by Moderna with the SEC, which are available on Moderna’s website at www.modernatx.com and on the SEC’s website at www.sec.gov. Except as required by law, Moderna and Recipharm each disclaim 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.