30 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Del Mar Pharmaceuticals announced a strategic collaboration with Guangxi Wuzhou Pharmaceutical, a subsidiary of publicly traded Guangxi Wuzhou Zhongheng Group for the development of VAL-083, known as "DAG for Injection" in China.
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 US 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.
Xu Shuqin, chairman of the Zhongheng Group, said that, "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. 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."