Celsion’s New Subsidiary in China to Serve as Beachhead for Commercializing ThermoDox® in China and Southeast Asia
December 18 2019 - 8:00AM
Celsion Corporation (NASDAQ:
CLSN), an oncology drug
development company, announces the signing of a memorandum of
understanding (MOU) with officials from the Hangzhou Yuhang
Economic Development Area to establish a subsidiary in the Yuhang
District of Hangzhou, the capital of China’s Zhejiang Province. The
Area, also known as the Qianjing Economic Development Area, is
located in China’s biotech hub, where the Chinese government has
made the development of advanced medical technologies that address
unmet patient needs a high priority.
The primary purpose of this new subsidiary is to
commercialize innovative cancer therapies starting with ThermoDox®,
the Company’s treatment for hepatocellular carcinoma (HCC), or
primary liver cancer. ThermoDox is currently in global Phase III
studies including 17 sites in China. In addition to China, the
subsidiary will focus on all nearby developing markets including
the Philippines, Malaysia, Thailand and Vietnam. Hisun, Celsion’s
local manufacturing partner, is expected to provide an economically
viable ThermoDox® cost structure by establishing a low-cost base of
production for these geographies. Registration of the subsidiary is
expected to be completed in 2020, with full operation expected in
the first half of 2021.
The MOU provides numerous incentives from the
Hangzhou municipal government under the central government’s policy
that are expected to benefit Celsion and the new subsidiary
including reimbursement for personnel recruiting, rent-free office
space for three years and tax abatements associated with certain
capital investments. The Company’s immediate financial obligation
under the agreement will be offset by future grants tied to
progress with clinical research programs.
“We are delighted progress is being made with
the Chinese government and Hisun as our manufacturing partner to
establish a subsidiary in the biotech capital of China,” said Mr.
Michael Tardugno, Celsion’s chairman, president and CEO. “This
agreement presents an excellent path to value creation for our
shareholders, while providing Celsion with a physical presence in
China. China has the world’s largest middle class and the second
largest healthcare market, and annual healthcare expenditures are
expected to increase from $750 billion in 2017 to $1.1 trillion by
2021, with a compound annual growth rate thereafter of 20%,” he
added. “We are grateful for the support of the Chinese government
as we establish our commercial footprint, with plans to tap into
nearby developing Asian economies. The structure of the agreement
permits us to leverage the subsidiary platform and capabilities to
in-license, develop and commercialize additional products, as well
as expanded indications for heat-sensitive liposomes. The
subsidiary structure also provides opportunities to raise capital
in China through the Hong Kong or Shanghai Stock Exchange in the
future.”
Mr. Tardugno added, “With China accounting for
half of the 850,000 new cases of HCC worldwide, the disease is a
major public health problem. Celsion and ThermoDox are well known
to Chinese KOLs as the current fully enrolled Phase III OPTIMA
Study of ThermoDox plus radiofrequency ablation (RFA) to treat HCC
includes 17 sites in China. Because principal investigators there
were also involved with our earlier Phase III HEAT Study, they are
familiar with the pooled subgroup data upon which the OPTIMA Study
is based. Those data showed a two-year overall survival benefit
from ThermoDox when compared with RFA alone. The NMPA, China’s
pharmaceutical regulatory agency, is supportive of our development
work with ThermoDox and is eager to find new treatments for
HCC.”
“We expect a second interim efficacy analysis
for the OPTIMA Study to occur in the second quarter of 2020, so the
timing is right to establish a subsidiary in China to prepare to
enter this very large market as quickly as possible, should the
drug be approved. In addition, we expect the decades of experience
Celsion management and its board of directors have in building
healthcare businesses in China to support all aspects of this new
venture,” Mr. Tardugno added.
About ThermoDox®
Celsion’s most advanced program is a
heat-mediated drug delivery technology that employs a novel
heat-sensitive liposome engineered to address a range of
difficult-to-treat cancers. The first application of this platform
is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD),
whose novel mechanism of action delivers high concentrations of
doxorubicin to a region targeted with the application of localized
heat at 40°C, just above body temperature. ThermoDox® is positioned
for use with multiple heating technologies and has the potential to
treat a broad range of cancers including metastatic liver,
recurrent chest wall breast cancer and non-muscle invading bladder
cancers.
Celsion’s LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. In the first mechanism, rapidly
growing tumors have leaky vasculature, which is permeable to
liposomes and enables their accumulation within tumors. Leaky
vasculature influences a number of factors within the tumor
including the access of therapeutic agents to tumor cells.
Administered intravenously, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the
tumor site as these liposomes recirculate in the blood stream. In
the second mechanism, when an external heating device heats tumor
tissue to a temperature of 40°C or higher, the heat-sensitive
liposome rapidly changes structure and the liposomal membrane
selectively dissolves, creating openings that can release a
chemotherapeutic agent directly into the tumor and the surrounding
vasculature. Drug concentration increases as a function of the
accumulation of liposomes at the tumor site, but only where the
heat is present. This method damages only the tumor and the area
subject to tumor invasion, supporting more precise drug
targeting.
About Celsion
Corporation
Celsion is a fully integrated oncology company
focused on developing a portfolio of innovative cancer treatments,
including directed chemotherapies, immunotherapies and RNA- or
DNA-based therapies. The Company's lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary
liver cancer. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
Celsion has two platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies. For more information on Celsion, please visit
www.celsion.com.
Celsion wishes to inform readers that
forward-looking statements in this release are made pursuant to the
"safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, unforeseen changes in the course of research and
development activities and in clinical trials; the uncertainties of
and difficulties in analyzing interim clinical data; the
significant expense, time, and risk of failure of conducting
clinical trials; the need for Celsion to evaluate its future
development plans; possible acquisitions or licenses of other
technologies, assets or businesses; possible actions by customers,
suppliers, competitors, regulatory authorities; and other risks
detailed from time to time in Celsion's periodic reports and
prospectuses filed with the Securities and Exchange Commission.
Celsion assumes no obligation to update or supplement
forward-looking statements that become untrue because of subsequent
events, new information or otherwise.
Celsion Investor ContactJeffrey
W. ChurchExecutive Vice President and CFO609-482-2455
jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
# # #
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Celsion (NASDAQ:CLSN)
Historical Stock Chart
From Sep 2023 to Sep 2024