GCIShield Therapeutics to launch Accrufer® in US on 1 July 2021
(STX ) has confirmed that it will launch Accrufer®, its iron-containing medication for the treatment of adults with low iron stores, in the US on 1 July 2021.
The commercial stage pharmaceutical firm which is focused on treating iron deficiency said launch stocks of Accrufer® are currently being distributed through the wholesaler channels and will be available to doctors and other prescribers in all parts of the US by next week.
The company informed investors that a sales force including 30 sales representatives has been recruited and trained and will be starting to contact key prescribers during next week.
Greg Madison, Chief Executive of Shield Therapeutics, said "We are pleased to make Accrufer® available to physicians and their patients in the US. Iron deficiency and iron deficiency anemia are significant challenges for millions of patients. Accrufer® represents a novel form of oral iron which offers clinical effectiveness while being well tolerated in clinical trials, and has the potential to be a significant advance for those patients in the US."
Looking back on the year ended 31 December 2020, the group said its ‘most significant effort’ in 2020 was finding a route to the US market for Accrufer®. After several discussions with potential partners, the company decided to push forward with a self-launch, a move which it believes can generate greater value for shareholders than with a licence deal.
The Board anticipates that rising sales of Accrufer® in the US should result in the Company’s monthly cash flow turning positive between 15-18 months after the initial launch as well as hold the potential for net sales to reach $100 million in the third year after launch.
‘Instead of receiving a royalty stream, perhaps averaging 15%-20%, on a US partner's sales, we will now benefit from a high margin product whose sales could grow to $300 million to $400m over the next five to six years and which is patent protected until 2035,’ it noted.
View from Vox
Shield previously 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.
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.
Despite shares having more than halved in recent months following the news that STX would not be signing a US marketing deal before the end of 2020, STX’s Directors believe its recent fundraising fulfils the necessary requirements for a Shield-led US launch of Accrufer®, a pathway they view as having the potential to generate significant returns for shareholders.
In addition, last month’s news that the company had acquired an additional listing on OTCQX market is expected to increase STX’s visibility to US investors ahead of Accrufer®’s launch.
Shares in Shield Therapeutics were trading 6.36% higher this morning at 58.5p immediately following the announcement.
Reasons to STX
Shield Therapeutics is 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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