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:
- Hisun 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;
- Hisun 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
- Hisun 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.