Celsion Corporation and Zhejiang Hisun Pharmaceutical Company Sign Technology Transfer, Manufacturing and Commercial Supply A...
August 09 2016 - 9:00AM
Celsion Corporation (NASDAQ:CLSN), a leading oncology drug
development company, announced today that it has signed a long-term
Technology Transfer, Manufacturing and Commercial Supply Agreement
(the “Agreement”) with Zhejiang Hisun Pharmaceutical Co. Ltd. (SSE
Code:600267), a leading pharmaceutical company in China, to pursue
an expanded partnership for the technology transfer relating to the
clinical and commercial manufacture and supply of GEN-1, Celsion’s
proprietary gene mediated, IL-12 immunotherapy, for the greater
China territory, with the option to expand into other countries in
the rest of the world after all necessary regulatory approvals are
in effect. GEN-1 is currently being evaluated by Celsion in
first line ovarian cancer patients.
The Agreement will help to support supply for
both ongoing and planned clinical studies in the United States, and
for potential future studies of GEN-1 in China. Hisun is one
of the largest manufacturers of oncology agents globally, including
ThermoDox®, Celsion’s heated activated liposomal dosage form of
doxorubicin, and is also a leading manufacturer for multinational
pharmaceutical companies.
“Hisun has already proven itself to be an
exceptional partner through our existing ThermoDox® collaboration,
and has been the source of high quality, cost-effective
manufacturing. We are delighted to have the opportunity to
expand our relationship, and to further harness their
state-of-the-art manufacturing expertise and facilities through
this newly established GEN-1 Agreement,” said Michael H. Tardugno,
Celsion's Chairman, President and Chief Executive
Officer. “Our partnership with Hisun serves multiple strategic
purposes towards successful GEN-1 approval and eventual product
launch both in China and internationally. Hisun’s expertise
may provide an advantage when seeking China Food and Drug
Administration (CFDA) approval, as well as securing a long-term
supply for one of the largest markets for ThermoDox® in the
world.”
Key provisions of the partnership are as
follows:
- The Agreement has targeted unit costs for clinical supplies of
GEN-1 that are substantially competitive with the Company’s current
suppliers;
- Once approved, the cost structure for GEN-1 will support rapid
market adoption and significant gross margins across global
markets;
- Celsion will provide Hisun a percentage certain of China’s
commercial unit demand, and separately of global commercial unit
demand, subject to regulatory approval;
- Hisun and Celsion will commence technology transfer activities
relating to the manufacture of GEN-1, including all studies
required by CFDA for site approval; and
- Hisun will collaborate with Celsion around the regulatory
approval activities for GEN-1 with the CFDA. A local China
partner affords Celsion access to accelerated CFDA review and
potential regulatory exclusivity for the approved indication.
Mr. Hua Bai, CEO and Chairman of Hisun, stated
“It is a pleasure to continue our relationship with Celsion, and we
are delighted to be their partner of choice as they continue
forward with the development of GEN-1, which may hold the potential
to address a significant public health issue not only in China, but
globally. We look forward to formalizing this long-term commercial
supply agreement, and to continuing our transition from a
traditional generics business to a branded global oncology
franchise. With the wide prevalence of cancers in China,
Hisun is well-positioned to aid in Celsion’s global effort to
develop this important immuno-oncology therapeutic for this vast
territory.”
In June 2012, Celsion and Hisun signed a
long-term commercial supply agreement for the production of
ThermoDox®, Celsion's proprietary heat-activated liposomal
encapsulation of doxorubicin. Hisun is one the largest
manufacturers of chemotherapy agents globally, including
doxorubicin. In July 2013, the ThermoDox® collaboration was
expanded to focus on next generation liposomal formulation
development with the goal of creating safer, more efficacious
versions of marketed cancer chemotherapeutics. During 2015,
Hisun successfully completed the manufacture of three registration
batches for ThermoDox® and has obtained regulatory approvals to
supply ThermoDox® to participating clinical trial sites in all of
the countries of Southeast Asia, Europe and North America, as well
as to the European Union countries allowing for early access to
ThermoDox®. The future manufacturing of clinical and
commercial supplies by Hisun will result in a cost structure
allowing Celsion to profitably access all global markets, including
third world countries, and help accelerate the Company’s product
development program in China for ThermoDox® in primary liver cancer
and other indications.
About GEN-1 Immunotherapy
GEN-1 is a development stage immunotherapeutic.
It is currently being evaluated as a first line treatment in
combination with chemotherapy in a Phase I study of newly diagnosed
ovarian cancer patients. GEN-1 is designed using the
TheraPlas™ platform technology, is an IL-12 DNA plasmid vector
encased in a nanoparticle delivery system which enables cell
transfection followed by persistent, local secretion of the IL-12
protein. IL-12 is one of the most active cytokines for the
induction of potent anti-cancer immunity acting through the
induction of T-lymphocyte and natural killer (NK) cell
proliferation. The Company has previously reported positive
safety and encouraging Phase I results in previous trials of GEN-1
given as monotherapy in patients with peritoneally metastasized
ovarian cancer and in combination with PEGylated doxorubicin in
patients with platinum resistant ovarian cancer. The application of
GEN-1 in ovarian cancer provides for a unique approach using
immunotherapy for this indication.
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 and in Phase II development for the treatment of
recurrent chest wall breast cancer. The pipeline also
includes GEN-1, a DNA-based immunotherapy for the localized
treatment of ovarian and brain cancers. Celsion has two
platform technologies for the development of novel nucleic
acid-based immunotherapies and other anti-cancer DNA or RNA
therapies, including TheraPlas™ and TheraSilence™. For more
information on Celsion, visit our website:
http://www.celsion.com. (TheraPlas/GEN-1, OVATION
Study/Ovarian Cancer)
About Zhejiang Hisun Pharmaceutical
Company Ltd.
Founded in 1956, the mission for Zhejiang Hisun
Pharmaceuticals Co., Ltd. (stock code 600267) hereinafter called
"Hisun" is to be persistent in pharmaceutical innovation for
humans' well-being. Hisun's vision is to become a widely
respected global pharmaceutical provider. It focuses on the
integration of pharmaceutical research and development (R&D)
with production resources in order to provide its global customers
with outstanding products and services. To date, over 40 of
the company's products have passed certification by many regulatory
agencies such as the FDA (U.S.), EDQM (EU), TGA (Australia) , and
KFDA (Korea) and are sold to more than 30 countries worldwide.
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 significant
expense, time, and risk of failure of conducting clinical trials;
HEAT Study data is subject to further verification and review by
the HEAT Study Data Management Committee; the need for Celsion to
evaluate its future development plans; termination of the
Technology Development Contract or collaboration between Celsion
and HISUN at any time; possible acquisitions or licenses of other
technologies, assets or businesses or the possible failure to make
such acquisitions or licenses; possible actions by customers,
suppliers, competitors, regulatory authorities; and other risks
detailed from time to time in the 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 Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
Hisun Investor Contact
Madam Zhang Min
Stock600267@hisunpharm.com
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