Arcturus Therapeutics Holdings Inc. (“Arcturus”, “the Company”,
Nasdaq: ARCT), a leading clinical-stage messenger RNA (mRNA)
medicines and vaccines company, and Catalent, Inc. (NYSE: CTLT),
the leading global provider of advanced delivery technologies,
development, and manufacturing solutions for drugs, biologics, cell
and gene therapies, and consumer health products, today announced a
partnership to support the expected manufacture of Arcturus’
COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect
against the SARS-CoV-2 coronavirus.
LUNAR-COV19 utilizes Arcturus’ self-transcribing and replicating
mRNA (STARR™) technology and the Company’s LUNAR® lipid-mediated
delivery to produce an extraordinarily low dose, potential single
shot COVID-19 vaccine.
The manufacture of LUNAR-COV19 at Catalent’s state-of-the-art
drug substance biomanufacturing facility in Madison, Wisconsin will
support human clinical studies and, if successful,
commercialization of the vaccine. The COVID-19 vaccine program will
take advantage of the facility’s flex-suite, a cGMP manufacturing
suite that can produce batches at multiple scales and support
Arcturus’ proprietary mRNA manufacturing process.
The partnership will combine Arcturus’ low-dose STARR™ mRNA
vaccine technology with Catalent’s scalable cGMP manufacturing
capabilities to produce millions of doses of LUNAR-COV19 mRNA in
2020 and potentially 100s of millions of doses annually for
worldwide use. Preparations for this program have already begun at
the Madison facility, and both organizations are committed to
meeting the global demand on unprecedented manufacturing timelines.
Technology transfer will be completed this month and manufacture of
the first cGMP batches of LUNAR-COV19 mRNA are expected to be
completed by June 2020.
“Catalent is proud to partner with Arcturus in the pursuit of a
vaccine that could protect people against the coronavirus
pandemic,” said John Chiminski, Chair and Chief Executive Officer
of Catalent. “Our unique experience and flex-suite cGMP capacity
will enable rapid scale-up of Arcturus’ proprietary manufacturing
process to make the vaccine available as soon as possible.”
Joseph Payne, President & CEO of Arcturus, stated,
“Government agencies and foundations are securing rights and access
to vaccines being developed to protect their respective
populations. The Catalent Biologics team and their high-tech
Madison facility is ideally suited to manufacture a substantial
number of doses. Arcturus will be better positioned to supply these
entities with our COVID-19 vaccine candidate on an accelerated
basis with Catalent as our manufacturing partner.”
STARR™ and LUNAR® are trademarks of Arcturus Therapeutics.
About Arcturus Therapeutics
Founded in 2013 and based in
San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq:
ARCT) is a clinical-stage mRNA medicines and vaccines company with
enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii)
STARR™ mRNA Technology and (iii) mRNA drug substance along with
drug product manufacturing expertise. Arcturus’ diverse pipeline of
RNA therapeutic candidates includes programs to potentially treat
Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis,
Glycogen Storage Disease Type 3, Hepatitis B, non-alcoholic
steatohepatitis (NASH) and a self-replicating mRNA vaccine for
SARS-CoV-2. Arcturus’ versatile RNA therapeutics platforms can be
applied toward multiple types of nucleic acid medicines including
messenger RNA, small interfering RNA, replicon RNA, antisense RNA,
microRNA, DNA, and gene editing therapeutics. Arcturus’
technologies are covered by its extensive patent portfolio (187
patents and patent applications, issued in the U.S., Europe, Japan,
China and other countries). Arcturus’ commitment to the development
of novel RNA therapeutics has led to collaborations with Janssen
Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies
of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda
Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics
Inc., Duke-NUS, and the Cystic Fibrosis Foundation. For more
information visit www.ArcturusRx.com
About Catalent Biologics
Catalent Biologics is a global
leader in development, manufacturing and analytical services for
new biological entities, cell and gene therapies, biosimilars,
sterile injectables, and antibody-drug conjugates. With over 20
years of proven expertise, Catalent Biologics has worked with 600+
mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using
GPEx® cell line development technology, and 35+ commercially
approved products. Catalent has recently acquired MaSTherCell, a
technology-focused cell therapy development and manufacturing
partner with expertise in autologous and allogeneic cell therapy
that complements Catalent’s industry-leading expertise and
commercial success in gene therapy development, manufacturing and
adeno-associated virus (AAV) vector production. Together, Paragon
Gene Therapy and MaSTherCell have produced over 100 GMP batches
across 60+ clinical and commercial programs. For more information
on Catalent Biologics, visit www.catalent.com/biologics
About Catalent
Catalent is the leading global provider of advanced delivery
technologies, development, and manufacturing solutions for drugs,
biologics, cell and gene therapies, and consumer health products.
With over 85 years serving the industry, Catalent has proven
expertise in bringing more customer products to market faster,
enhancing product performance and ensuring reliable global clinical
and commercial product supply. Catalent employs over 13,500 people,
including over 2,400 scientists and technicians, at more than 40
facilities, and in fiscal year 2019 generated over $2.5 billion in
annual revenue. Catalent is headquartered in Somerset, New Jersey.
For more information, visit https://www.catalent.com/
Arcturus Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. Any statements, other than statements of historical
fact included in this press release, including those regarding the
Company’s expected performance, the Company’s development of any
specific novel mRNA therapeutics, the Company’s efforts to develop
a vaccine against COVID-19 based on the Company’s mRNA
therapeutics, the forecasted safety, efficacy or reliability of a
vaccine against COVID-19, were one to be successfully developed
based on the Company’s mRNA therapeutics, the timing and
availability of a vaccine against COVID-19 were one to be
successfully developed based on the Company’s mRNA therapeutics,
the potential initiation of human trials of a vaccine against
COVID-19 based on the Company’s mRNA therapeutics, the timing of
initiation of human trials of a vaccine against COVID-19 based on
the Company’s mRNA therapeutics, the ability of any product to
receive regulatory approval in Singapore and whether or not any
other countries will accept the trials conducted in that
jurisdiction, the potential market impact of a vaccine against
COVID-19 based on the Company’s mRNA therapeutics, the potential
manufacturing capabilities of the Company’s partnership with
Catalent, the timing of technology transfer related to the
Company’s partnership with Catalent, the manufacture of GMP batches
of a vaccine against COVID-19, were one to be successfully
developed based on the Company’s mRNA therapeutics, any expected
benefit from the Company’s partnership with Catalent and timing of
any benefits related thereto and the impact of general business and
economic conditions are forward-looking statements. Arcturus may
not actually achieve the plans, carry out the intentions or meet
the expectations or projections disclosed in any forward-looking
statements such as the foregoing and you should not place undue
reliance on such forward-looking statements. Such statements are
based on management’s current expectations and involve risks and
uncertainties, including those discussed under the heading "Risk
Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal
year ended December 31, 2019, filed with the SEC on March 16, 2020
and in subsequent filings with, or submissions to, the SEC. No
assurances can be given that any results reported in pre-clinical
studies can be replicated in further studies or in human beings, or
that a vaccine can or will ever be developed or approved using the
Company’s technology. Except as otherwise required by law, Arcturus
disclaims any intention or obligation to update or revise any
forward-looking statements, which speak only as of the date they
were made, whether as a result of new information, future events or
circumstances or otherwise.
Catalent Forward-Looking Statement Notice
Statements concerning the development, success and
administration of clinical trials, ability to launch and future
manufacturing contained in this release are forward-looking
statements. They involve known and unknown risks, uncertainties,
and other factors that may cause actual results or performance to
be different from those expressed or implied in this release.
Catalent has based its forward-looking statements on its current
expectations, assumptions, estimates and projections, which it
believes to be reasonable, but various factors, including factors
beyond Catalent’s control, may affect future results or
performance. Among the factors that may affect these
forward-looking statements are: the rapidly changing market for
treatments and vaccines to address the COVID-19 pandemic, the
current or future effects of the COVID-19 pandemic, including its
effects on Catalent’s and its clients' businesses, the outcome of
the development of this or any competing vaccine or any treatment
for COVID-19, the outcome of any and all reviews, inspections or
other approvals by the U.S. Food and Drug Administration (FDA) or
similar regulatory health authority, customer and payor acceptance
of the proposed vaccine, any competing vaccine, or any treatment
for COVID-19, competitor responses to a potential future launch of
this vaccine, changes to the overall economic climate in the United
States or among potential purchasers of the product, changes to the
healthcare reimbursement system in the United States or elsewhere,
competing initiatives at Catalent or Arcturus, supply chain risks
relating to the vaccine, fluctuations in currency exchange rates
that affect Catalent’s ability to source the materials needed for
the production of the product, or potential third-party claims or
litigation related to the vaccine. These and other important
factors, including those discussed under “Risk Factors” in the
Catalent, Inc. Annual Report on Form 10-K for the year ended June
30, 2019, may affect future results or performance. Catalent makes
the statements in this release only as of the date of this release,
and Catalent disclaims any duty, except as required by law, to
update or revise any forward-looking statement, regardless of the
circumstances.
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Arcturus Investor and Media Contacts Neda Safarzadeh (858)
900-2682 IR@ArcturusRx.com
Carlo Tanzi, Ph.D. Kendall Investor Relations (617) 914-0008
ctanzi@kendallir.com
Catalent Media Contacts Chris Halling +44 (0)7580 041073
chris.halling@catalent.com
Richard Kerns +44 (0) 161 728 5880 richard@nepr.agency
Catalent Investor Contact Paul Surdez +1 (732) 537-6325
investors@catalent.com
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