Polaris Pharmaceuticals, Inc. (PPI)
The San Diego-based company was founded in 2008 and is responsible for the clinical development of the ADI-PEG 20.
Polaris Pharmaceuticals has an R&D division that conducts early stage drug discovery, translational research and pre-clinical research for a variety of cancer indications. It also has a clinical division responsible for executing global clinical studies for ADI-PEG 20.
DesigneRx Pharmaceuticals, Inc. (DRX-USA)
Founded in 2002, DRX-USA built a pilot cGMP facility for biologics in Vacaville, California in 2005 and has provided ADI-PEG 20 for all clinical studies for over 10 years.
The company completed a second cGMP production facility for ADI-PEG 20 in 2015 which will provide the initial global supply of ADI-PEG 20 after receiving regulatory approval.
DesigneRx Pharmaceuticals (Chengdu), Inc. (DRX-CD)
Located in Chengdu, China, DRX-CD acquired 68 acres of land in the Chengdu Hi-Tech Industrial Development Zone (CDHT) in 2013 to build a world-class large scale cGMP facility for biologics.
This commercial scale facility is designed to meet the rigorous regulatory requirements in the USA, EU and China. The building structures and major plant utilities were completed in Q1, 2016 and the cGMP manufacturing facility is projected for completion in 2018.
DesigneRx Pharmaceuticals (Shanghai), Inc. (DRX-SH)
Founded in 2007 in Shanghai, China, DRX-SH conducts translational research to identify additional cancer types for treatment with ADI-PEG 20. It is responsible for the clinical development of ADI-PEG 20 in China.
TDW Pharmaceuticals, Inc. (TDW)
The Taiwanese company was founded in 2003. It is responsible for clinical studies in Asia other than China.
TDW completed a multi-center Phase II clinical study in Taiwan for hepatocellular carcinoma in 2008, and is conducting multiple studies for ADI-PEG 20 in Taiwan.