Shield Therapeutics PLC (LON:STX) shares shot up 67% after it secured US regulatory sign-off for its iron deficiency treatment.
The Food & Drug Administration has given what’s called broad label approval to Feraccru, which will be marketed as Accrufer in America. It is already on sale in Europe.
Receiving the official green light for its lead product is a “big step towards exploiting the very large commercial opportunity”, Shield said.
The prescription market for iron replacement therapies Stateside is estimated to be worth over US$1bn annually.
The company said it is currently in discussions with potential partners that could help it exploit this significant opportunity.
“With this broad approval and IP protection out to 2035, Feraccru/Accrufer has a real and very attractive long-term market opportunity to exploit in the USA,” said chief executive Carl Sterritt.
“We have been pleased with the levels of interest and engagement shown by third-parties in commercialising Accrufer in the USA and we look forward to finalising these discussions and appointing a commercial partner In the world's most attractive pharmaceutical market, so that more patients with iron deficiency can benefit from treatment with Accrufer at the earliest opportunity."
Simple and effective
Outwardly simple, but with clinically-proven equivalent efficacy to intravenous iron, Feraccru is an oral product absorbed in the gut.
It is also an alternative for those unable to tolerate or unresponsive to first-line salt-based oral iron products.
Such patients have the second-line option of intravenous iron, which is painful and inconvenient.
So, Feraccru presents a much more convenient and potentially lower cost, safer alternative to intravenous iron, which needs to be administered in hospital because it always carries the risk of a severe and potentially fatal allergic reaction.
The company also has a pipeline of assets. The most advanced is PT20, a phase III-ready treatment for the electrolyte disorder, hypophosphatemia, which is extremely common in patients with chronic kidney disease.
Shield shares shot up 69.61p to 173.11p, valuing the business at just over £200mln.