On October 29, 2012 Del Mar Pharmaceuticals (BC) Ltd. ("DelMar") reported a strategic collaboration with Guangxi Wuzhou Pharmaceutical Company, a subsidiary of publicly traded Guangxi Wuzhou Zhongheng Group Co., Ltd (SHG 600252) for the development of VAL-083, known as "DAG for Injection" in China (Press release, DelMar Pharmaceuticals, OCT 29, 2012, View Source [SID1234556371]).
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DAG for Injection in China, is approved by the Chinese State Food and Drug Administration (SFDA) as a cancer chemotherapy for the treatment of Chronic Myelogenous Leukemia (CML) and lung cancer. Guangxi Wuzhou Pharmaceuticals is licensed by SFDA to manufacture and sell VAL-083 in China for these indications.
DelMar is conducting clinical studies using the Guangxi Wuzhou Pharmaceutical’s drug product in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
In addition, DelMar is conducting research aimed at demonstrating the utility of DAG for Injection in cancers refractory to current therapies. Recently published data elucidated sub-types of CML and lung cancer that are uniquely prevalent in persons of East Asian decent and highly resistant to treatment by tyrosine kinase inhibitors (TKIs). DelMar’s research demonstrates activity against cancer cell lines resistant to TKI therapy.
The Companies plan to use new data being generated through DelMar’s clinical programs to expand the market in China and to seek regulatory approval for the drug in multiple indications on a global basis.
The collaboration expands the exclusive supply relationship between DelMar and Guangxi Wuzhou Pharmaceuticals to include the Chinese market and all markets outside China. The companies will work together to insure the product specifications meet global standards in order to accelerate international development and regulatory approval. Wuzhou Pharmaceuticals will be the exclusive supplier of DAG for Injection and DelMar will be responsible for development and commercialization.
"This expanded collaboration positions DelMar to unlock the value of our research by benefiting patients in China where our VAL-083 is already approved as a cancer chemotherapy," said Jeffrey Bacha, President & CEO of DelMar.
The expanded collaboration, was announced at a joint press conference and signing ceremony in Wuzhou China on October 24, 2012. During the ceremony, Chen Ming, Vice Chairman of Zhongheng Group, outlined six key areas of focus for the collaboration:
Seek approval from regulatory authorities outside China, including the FDA, EMEA and other international jurisdictions to commercialize DAG for Injection for the treatment of GBM and other indications;
DelMar will support Wuzhou Pharmaceuticals by developing and providing new clinical and non-clinical data for the approved indications in China in order to support marketing and sales of DAG for Injection in China;
Wuzhou Pharmaceutical will assist and provide financial support for DelMar to initiate development work in one or more Clinical Centers in China as part of an international multi-center clinical development strategy;
DelMar will provide clinical and non-clinical data to support Wuzhou Pharmaceuticals to obtain approval of DAG for Injection from SFDA for new indications, including GBM;
DelMar and Wuzhou Pharmaceuticals will work together to enable Wuzhou Pharmaceuticals to obtain FDA certification as a cGMP manufacturer of DAG for Injection; and
Through co-development of DAG for injection, the collaboration will seek to maximize the value of Wuzhou Pharmaceuticals business in China and create a foundation for sales in international markets.
Xu Shuqin, Chairman of Zhongheng Group said, "It is understood that, through this collaboration, we will seek to establish approval of DAG for Injection through international authorities including FDA and EMEA and other international jurisdictions outside China for multiple indications including brain cancer. DelMar will assist Wuzhou Pharmaceuticals within China to support sales and marketing of the product and promote the optimization of production and quality assurance to meet international standards. Wuzhou Pharmaceuticals will assist DelMar by supporting international multi-center clinical trials. We will work together to jointly develop and promote Wuzhou Pharmaceuticals business in China, to maximize the value of products sold in the international market, and to lay the foundation for more extensive collaboration opportunities."