It took a decade for the Australian biopharmaceutical company Alchemia to get its generic blood-thinning drug fondaparinux onto shelves in the United States, after first having it patented in 2001.
Used predominantly in the treatment of deep vein thrombosis, the drug is a generic version of drug giant GlaxoSmithKline’s Arixtra. Alchemia’s version finally won FDA approval in the United States in July 2011 and illustrates the challenges biotech and medical start-up companies face in getting their products to market.
Although Alchemia reported an overall net loss of $15.8 million for the 2015 financial year, the company’s 2015 annual report shows it received a share of the net profit from the sale of fondaparinux by its marketing partner, Dr Reddy’s Laboratories in the order of US$4.4 million. In 2014, it was US$7.5 million.
Alchemia patented the generic fondaparinux for the "composition of matter and process for synthetic heparin". The patent protects the tricky way fondaparinux is manufactured in large quantities.
Currently, fondaparinux is the biotech company’s only commercially available drug, but others such as HA-Doxorubicin and HA-5-Fluorouracil are in the pipeline.
Alchemia's VAST Drug Discovery Platform uses new ways to discover and develop small molecule drugs. The platform has been tested by the Monash Institute for Pharmaceutical Sciences and the University of Queensland. The company’s website points out that research in this field has attracted the partnership of Astra Zeneca - a global biopharmaceutical company engaged in the research, development, manufacture and supply of medicines.
Additionally, Alchemia's HyACT is a platform technology for improving anti-cancer drugs. Both these projects were supported through grants, and help from the Institute for Molecular Bioscience and the Walter and Eliza Hall Institute.