Australian Intellectual Property Report 2013
What does it take to lead a biotech start-up? Try nerves of steel, the patience of a saint, and a brains trust of PHDs and MBAs.
If anyone doubted the enormous challenges bringing new therapies to market, then consider Alchemia. The biotech patented it's blood thinning drug (generic fondaparinux) on 7 September 2001. It wasn't finally approved for sale in the USA until 11 July 2011.
On 6 February 2012, Alchemia announced weekly sales in excess of US$1.4 million. Its marketing deal with Dr Reddy's Laboratories was paying off. Within weeks the company's shares surged some 50% in value.
Alchemia's CEO, Pete Smith said, "We are very happy with the advances made by Dr Reddy's both in terms of the market share achieved and the increases in yields and production capacity. With this strong performance we believe that we are on track to meet our expectations for fondaparinux in 2012".
Those expectations include making money for the first time.
Alchemia's only drug for sale is a generic version of GlaxoSmithKline's 'Arixtra'. It has patented the "composition of matter and process for synthetic heparin" (generic fondaparinux). This patent protects the tricky way fondaparinux is manufactured in large quantities.
Pete Smith, CEO
Alchemia has dozens of patents in many countries. Foundaparinux is just the first of several products in the pipeline. Others include a drug discovery technology and cancer therapies.
Alchemia's VAST 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. Both these projects are supported through grants, and help from the Institute for Molecular Bioscience and the Walter and Eliza Hall Institute.
There are other developments in the pipeline. Alchemia's HyACT is a platform technology for improving anti cancer drugs. It targets the drug to the tumour, enabling much higher doses of chemotherapy without dangerous side effects. HyACT is a few years off, but it could make a lot more money than generic fondaparinux.
Alchemia's work on cancer therapies may benefit from the research exemptions now in force under The Intellectual Property Laws Amendment (Raising the Bar) Act 2012. These exemptions clarify the rights of researchers to work on improving patented inventions. It's a significant step towards removing some of the uncertainties around our patents system. Even for a success like Alchemia, inventing life-changing new medicines is not easy.
Last Updated: 18/4/2013
