Shield Therapeutics PLC (LON:STX) said Australia's Therapeutics Goods Administration has approved its drug Feraccru to treat iron deficiency with or without anaemia in adults.
The product already has the regulatory green light in the UK, European Union, Switzerland and the United States (where it is called Accrufer).
A firm called Norgine will lead the marketing activities for Feraccru in Australia, Shield said.
The update comes just 10 days after the Shield announced it had raised £25mln to launch the breakthrough treatment in the US, the world’s largest pharmaceutical market.
Estimates generated by management consultants and other third parties support the potential for sales to exceed US$100mln from the third year following launch, it said, and to reach US$300mln-US$400mln by years five to six.
Allowing for launch costs, breakeven on a monthly basis will be within 15-18 months after launch and Shield believes funding of around US$30mln to US$40mln would be enough to reach breakeven.