Shield Therapeutics (STX ) unveiled that Australia's Therapeutic Goods Administration (TGA) has approved Feraccru® as a treatment for iron deficiency with or without anaemia in adults.
The commercial stage pharmaceutical company focused on addressing iron deficiency with its lead product Feraccru®/Accrufer® (ferric maltol) confirmed to investors that the TGA has registered Feraccru® as a treatment in the Australian Register of Therapeutic Goods.
Australia’s Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government responsible for regulating therapeutic goods from prescription medicines and vaccines to vitamins and medical devices.
Under the deal, Netherlands-based Norgine Pty Ltd, which is a leading European specialist pharmaceutical company, will lead all marketing activities for Feraccru® in Australia.
Shield’s Feraccru® product is already approved across the UK, European Union, Switzerland and United States for the treatment of iron deficiency with or without anaemia in adults.
Shield has stated that the US market opportunity for Accrufer® is ‘substantial and growing’ and in Shield's head-to-head study, Accrufer® was identified to be a credible alternative to IV therapy particularly for maintaining haemoglobin levels over the long term.
Today’s news follows STX’s recent announcement that it had raised £25m at 30p in order to finance the launch of Accrufer® in the US, the largest pharmaceutical market. Specifically, the proceeds will be used to advance the self-commercialisation of its iron deficiency oral therapy treatment, Accrufer®, in the US first outlined in December 2020. This move has the potential to generate significant returns for Shield's shareholders with Potential sales estimates for Accrufer® in the US are forecasted to exceed $100 million from the third year following launch and to reach $300 million-$400 million by years five to six, which would generate a significant upside to the placing price. Following this latest approval from Australia's TGA, Shield continues to expand its market reach for its iron deficiency treatment on a global scale. The stock was trading 4.46% higher this morning at 41p following the announcement.
Reasons to Follow STX
Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru®/Accrufer®, a novel, non-salt based oral therapy for adults with iron deficiency with or without anaemia.
Proven and Approved
The Group’s Feraccru®/Accrufer® product has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s.
Feraccru® is commercialised across the UK and European Union by Norgine B.V. and the Company is currently in the process of evaluating commercialisation options for the US market, including the potential launch of Accrufer® in the US by Shield.
Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical to develop and commercialise Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan.
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