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news.Celsion has signed a long-term Technology Transfer, Manufacturing and Commercial Supply Agreement with Zhejiang Hisun Pharmaceutical to pursue an expanded partnership for the technology transfer relating to the clinical and commercial manufacture and supply of GEN-1, Celsion's 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.
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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.