Celsion Corporation and Zhejiang Hisun Pharmaceutical Company Sign Memorandum of Understanding for Future Development of

Celsion Corporation and Zhejiang Hisun Pharmaceutical Company Sign Memorandum
  of Understanding for Future Development of ThermoDox® and Other Liposomal
                                 Formulations

Continuation of Technology Development and Commercial Supply Agreements for
ThermoDox® in the Greater China Territory

PR Newswire

LAWRENCEVILLE, N.J. and TAIZHOU CITY, China, July 19, 2013

LAWRENCEVILLE, N.J. and TAIZHOU CITY, China, July 19, 2013 /PRNewswire/ --
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development
company and Zhejiang Hisun Pharmaceutical Company Ltd. (SSE Code: 600267), a
leading Chinese pharmaceutical company, announced today that they have entered
into a Memorandum of Understanding to pursue ongoing collaborations for the
continued clinical development of ThermoDox® as well as the technology
transfer relating to the commercial manufacture of ThermoDox® for the greater
China 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 January 2013, a Technology Development Agreement was signed
whereby Hisun paid Celsion a non-refundable payment of $5 million in exchange
for Celsion providing Hisun with support for its ThermoDox® manufacturing
development program. In addition, the expanded collaboration will focus on
next generation liposomal formulation development with the goal of creating
safer, more efficacious versions of marketed cancer chemotherapeutics.

Among the key provisions of the Celsion-Hisun collaboration are:

  oHisun will provide Celsion with non-dilutive financing and the investment
    necessary to complete the technology transfer of its proprietary
    manufacturing process and the production of registration batches for
    China;
  oHisun will collaborate with Celsion around the clinical and regulatory
    approval activities for ThermoDox® as well as other liposomal formations
    with the China state Food and Drug Administration (SFDA). A local China
    partner affords Celsion access to accelerated SFDA review and potential
    regulatory exclusivity for the approved indication; and
  oHisun will be granted a right of first offer for a commercial license to
    ThermoDox® for the sale and distribution of ThermoDox® in the greater
    China territory.

"We are delighted with our continuing collaboration with Hisun which serves
multiple strategic purposes towards successful ThermoDox® drug development and
eventual product launch in the China market, potentially the largest
opportunity in the world for ThermoDox®," said Michael H. Tardugno, Celsion's
President and Chief Executive Officer. "Hisun represents an ideal strategic
partner due to their regulatory and manufacturing expertise. We will work
very closely with Hisun to accelerate our drug development program in China
for ThermoDox® in primary liver cancer and other indications."

Mr. Hua Bai, CEO and Chairman of Hisun, stated, "We are pleased to announce
our expanded collaboration with Celsion for the continued development of
ThermoDox® to treat HCC to patients in China, the world's largest market.
China is one of the countries with the highest HCC incidence and mortality
and, up until now, there has not been any standard of care for treating
intermediate HCC in China. This joint effort will not only focus on ThermoDox
for HCC and other indications but will also facilitate the local manufacturing
and potential product launch in China, thereby providing physicians with more
options for better care and prolonging the survival of patients."

About ThermoDox®

ThermoDox® is a proprietary heat-activated liposomal encapsulation of
doxorubicin, an approved and frequently used oncology drug for the treatment
of a wide range of cancers. In the HEAT Study, ThermoDox® is administered
intravenously in combination with RFA. Localized mild hyperthermia (39.5 - 42
degrees Celsius) created by the RFA releases the entrapped doxorubicin from
the liposome. This delivery technology enables high concentrations of
doxorubicin to be deposited preferentially in a targeted tumor.

For primary liver cancer, ThermoDox® is being evaluated in a 700 patient
global Phase III study at 79 clinical sites under an FDA Special Protocol
Assessment. The study is designed to evaluate the efficacy of ThermoDox® in
combination with RFA when compared to patients who receive RFA alone as the
control. On January 31, 2013, Celsion announced that ThermoDox® in combination
with RFA did not meet the primary endpoint of the HEAT study in patients with
hepatocellular carcinoma, also known as primary liver cancer. Celsion has
conducted a comprehensive analysis of the data from the Phase III HEAT Study
with key principal investigators, data experts and liver cancer experts.
Emerging data from the HEAT Study post hoc analysis demonstrates that
ThermoDox® markedly improves PFS and overall survival in patients if their
lesions undergo RFA for 45 minutes or more. These findings apply to HCC
lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and
represent a sizable subgroup of approximately 300 patients.

About Celsion Corporation

Celsion is dedicated to the development and commercialization of innovative
cancer drugs, including tumor-targeting treatments using focused heat energy
in combination with heat-activated liposomal drug technology. Celsion has
research, license or commercialization agreements with leading institutions,
including the National Institutes of Health, Duke University Medical Center,
University of Hong Kong, the University of Pisa, the UCLA Department of
Medicine, the Kyungpook National University Hospital, the Beijing Cancer
Hospital and the University of Oxford. For more information on Celsion, visit
our website: http://www.celsion.com.

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. The company'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 Wei
Stock600267@hisunpharm.com









SOURCE Celsion Corporation

Website: http://www.celsion.com
 
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