Celsion Announces ThermoDox(R) Commercial Supply Agreement With Hisun
LAWRENCEVILLE, NJ -- (Marketwire) -- 05/07/12 -- Celsion Corporation (CLSN), a leading oncology drug development company, announced today that it has signed a long term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (SSE Code: 600267), a leading pharmaceutical company in China, 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, and a leading manufacturer for multinational pharmaceutical companies, through partnerships such as the $295 million Joint Venture with Pfizer, signed in February 2012.
Among the key provisions of the Celsion-Hisun partnership are:
- The Agreement 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;
- The Agreement will initially be limited to China, the largest incidence market for Hepatocellular Carcinoma (HCC), or primary liver cancer, with Hisun retaining an option for global supply after local regulatory approvals in China;
- Hisun will collaborate with Celsion around the regulatory approval activities for ThermoDox® 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
- The manufactured price for ThermoDox® to Celsion under this Agreement will support high gross margins across global territories.
"Our partnership with Hisun serves multiple strategic purposes towards successful ThermoDox® drug approval and eventual product launch both in China and internationally. Hisun's expertise will provide an advantage to seeking China SFDA approval, as well as securing a long term supply for one of the largest markets for ThermoDox® in the world," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "In addition, this partnership brings a timely investment for the expansion of our manufacturing and CMC efforts, accelerating our drug development program. As one of the largest suppliers of doxorubicin, Hisun represents an ideal strategic partner."
Mr. Hua Bai, CEO and Chairman of Hisun, stated, "I can say unequivocally that Hisun is delighted to be a partner of choice for Celsion and to participate in the potential that ThermoDox® represents in addressing a significant public health issue in China. Our team is excited to formalize this long-term commercial supply agreement. We are particularly interested in continuing our transition from a traditional generics business to a branded oncology franchise. With the wide prevalence of liver cancer in China, we look forward to supplying ThermoDox® for this vast territory."
The HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA), has received FDA Fast Track Designation, and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. The European Medicines Agency (EMA) has confirmed the HEAT Study is acceptable as a basis for submission of a marketing authorization application (MAA). ThermoDox® has been granted orphan drug designation in both the U.S. and Europe. In addition to meeting the U.S. FDA and European EMA enrollment objectives, the HEAT Study has also enrolled a sufficient number of patients to support registration filings in China, South Korea and Taiwan, three of the largest markets for ThermoDox® around the world.
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer today is approximately 26,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 750,000 cases per year, 55 percent of which are in China, due to the high prevalence of Hepatitis B and C in developing countries. The World Health Organization estimates that primary liver cancer may become the number one cancer worldwide, surpassing lung cancer, by 2020.
The standard first-line treatment for liver cancer is surgical resection of the tumor; however, 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About ThermoDox® and the Phase III HEAT Study
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. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
About Celsion Corporation
Celsion is a leading oncology company 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, Kyungpook National University Hospital and the Beijing Cancer Hospital. For more information on Celsion, visit our website: http://www.celsion.com.
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Source: Celsion Corporation