Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology
company pioneering messenger RNA (mRNA) therapeutics and vaccines
to create a new generation of transformative medicines, 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
collaboration for large-scale, commercial fill-finish manufacturing
of Moderna’s mRNA vaccine candidate against COVID-19 (mRNA-1273) at
ROVI’s facility in Madrid, Spain.
As part of the agreement, ROVI will provide vial filling and
packaging capacity by procuring a new production line and equipment
for compounding, filling, automatic visual inspection and labeling
to support production of hundreds of millions of doses of the
vaccine candidate intended in principle to supply markets outside
of the U.S. starting in early 2021. ROVI will also hire additional
staffing required to support manufacturing operations and
production.
“Moderna is committed to helping address the COVID-19 crisis. We
are pleased to partner with ROVI to potentially supply hundreds of
millions of doses of finished mRNA-1273, once approved, and help
address the need for a vaccine against COVID-19 around the world,”
said Juan Andres, Moderna’s Chief Technology Operations and Quality
Officer. “ROVI’s experience as a global manufacturer of drug
product and expertise in fill-finish will be an important
partnership for us to establish dedicated supply chains that can
meet the needs of different countries and regions. I am delighted
to be working with ROVI again.”
“We are very happy about the collaboration with Moderna, whose
vaccine against COVID-19 is one of the frontrunners in the race to
solve this health crisis. We would be thrilled for ROVI to form
part of the solution to this pandemic that is affecting all of us
and to support Moderna in supplying it on a wide scale. Our proven
experience and capabilities as a toll manufacturer of injectables
has allowed us to reach this agreement, which would help strengthen
our manufacturing area and would, in all probability, provide us
with a significant growth opportunity in the area. Likewise, I
would like to thank the Ministry of Health and the Spanish
Medicines Agency for making themselves available and providing
their support, which has been of fundamental importance, during
this entire process,” said Juan López-Belmonte, Chief Executive
Officer of ROVI.
About mRNA-1273, Moderna’s Vaccine Candidate Against
COVID-19
mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding
for a prefusion stabilized form of the Spike (S) protein, which was
selected by Moderna in collaboration with investigators from
Vaccine Research Center (VRC) at the National Institute of Allergy
and Infectious Diseases (NIAID), a part of the National Institutes
of Health (NIH). On July 8, the Company’s Phase 2 study of
mRNA-1273 completed enrollment. Moderna’s Phase 3 study of
approximately 30,000 participants, is expected to begin in July
2020.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients and to protect
populations from vaccines preventable diseases. 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 five 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, which is
already marketed in 56 countries all over the world, should be
highlighted. Likewise, in 2017, ROVI commenced the marketing of its
in-house developed enoxaparin biosimilar in Europe. 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 the Company’s development of
a potential vaccine against the novel coronavirus, the scope of the
Company’s manufacturing collaboration with ROVI, the potential
number of doses to be provided under the collaboration, the timing
of supply of mRNA-1273 outside of the U.S., and the timing of the
planned Phase 3 study of mRNA-1273. 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 manufacturing infrastructure required to
manufacture mRNA-1273 by Moderna is still being developed and
implemented; the fact that the safety and efficacy of mRNA-1273 has
not yet been established; 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 described under
the heading “Risk Factors” in Moderna’s most recent Quarterly
Report on Form 10-Q 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.
ROVI’s Forward-Looking Statements
This news 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 condition, performance, or achievements of ROVI
or industry results, to be materially different from any future
results, performance, or achievements expressed or implied by such
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 manufacturing infrastructure required to manufacture
mRNA-1273 is still being developed and implemented; the fact that
the safety and efficacy of mRNA-1273 has not yet been established;
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 of this
press release. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200709005490/en/
Moderna
Media: Colleen Hussey Senior Manager, Corporate
Communications 203-470-5620 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
Rovi
Media: Beatriz García Suárez +34 662 570 818
bgarciasuarez@rovi.es
Investors: Marta Campos Martínez +34 607 539 780
mcampos@rovi.es
Antonio Marquina Ospina +34 674 315 715 amarquina@rovi.es
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