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
TherapeuticsFounded 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
BiologicsCatalent
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 CatalentCatalent 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
StatementsThis 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
NoticeStatements 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.
Arcturus Investor and Media Contacts Neda
Safarzadeh (858) 900-2682IR@ArcturusRx.com
Carlo Tanzi, Ph.D. Kendall Investor Relations(617)
914-0008 ctanzi@kendallir.com
Catalent Media ContactsChris Halling+44 (0)7580
041073chris.halling@catalent.com
Richard Kerns+44 (0) 161 728 5880richard@nepr.agency
Catalent Investor ContactPaul Surdez+1 (732)
537-6325investors@catalent.com
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