Celsion Corporation, a leading oncology drug development company, and Zhejiang Hisun Pharmaceutical Company Ltd., a leading Chinese pharmaceutical company, have entered into a technology development agreement for ThermoDox® for the greater China territory. Under the terms of the agreement, Hisun will pay $5 million to Celsion immediately, while Celsion will provide Hisun with support for its ThermoDox® manufacturing development program. This payment is non-refundable and comes in advance of Celsion’s expected reporting of results from its pivotal Phase III trial (the HEAT Study) in hepatocellular carcinoma (HCC), also known as 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% 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.
In addition, the companies anticipate signing an agreement in which Celsion provides Hisun an exclusive option to license ThermoDox® for the Greater China market, which includes China, Hong Kong and Macau. This option period will be secured by a second $5 million payment that must be received by Celsion from Hisun within 60 days after execution of the Technology Development Agreement. The key provisions of the anticipated license agreement have been negotiated and agreed to by the parties and provide a basis for a definitive contract.
“Pursuing this arrangement with Hisun allows us to evaluate the fastest path to the China market, potentially the largest opportunity in the world for ThermoDox®. A long-term partnership will provide the greatest synergies with respect to sales, marketing, distribution, and manufacturing, which could ensure significant value to the ThermoDox® asset,” said Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “In addition, this partnership provides Hisun and Celsion with immediate access to an accelerated pathway for SFDA review and approval of ThermoDox®, a business strategy with exceptional potential to serve China’s HCC population, and strong, uncompromised economics for both parties.”
Mr. Hua Bai, CEO and Chairman of Hisun, stated, “We are extremely excited to pursue this arrangement with Celsion. Hisun is well positioned to provide ThermoDox® — potentially one of the most important and innovative drugs 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 HCC in China. This joint effort will most likely facilitate the local manufacturing and commercial launch in China, thereby providing physicians with more options for better care and prolonging the survival of HCC patients. In the meantime, we are also hopeful that this collaboration will enable Hisun to increase its focus on more innovative drugs. Given the fact that we are a leading Chinese pharmaceutical company with international standards of R&D and manufacturing technology, Hisun will seek to manufacture and supply the global markets, along with distribution exclusivity in Greater China. This venture will help spearhead Hisun’s globalization in manufacturing and commercialization capabilities.”
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 potential markets for ThermoDox® around the world.
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