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.”
About Moderna
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.
About Recipharm
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.
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.
Recipharm Statement
This information 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 persons set out above on 29 December 2020 at 17:20
CET.
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version on businesswire.com: https://www.businesswire.com/news/home/20201230005278/en/
Moderna Contacts Media: Colleen Hussey Director,
Corporate Communications 617-335-1374
Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President &
Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
Recipharm Contacts Thomas Eldered, CEO, telephone: +46 8
602 52 10 Jean-François Hilaire, Executive Vice President,
telephone: +33 695 447 507 Tobias Häggl�v, CFO, ir@recipharm.com,
telephone: +46 8 602 52 00
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