Shares in a Tyneside pharmaceutical firm have soared after it received approval for the use of its drug in the US and said it would be targetting a market worth more than $1bn.
Shield Therapeutics, which is based in Gateshead, has announced that its Ferracru drug, which can be used for the treatment of iron deficiency in adults and will be marketed as Accrufer in the US, has been approved by the US Food and Drug Administration (FDA).
The news is a huge boost for the firm which saw its shares rise by more than 70% at lunchtime on Friday.
Shield had to significantly reduce its workforce and saw its share price plunge last February when Ferracru failed to reach initial trial targets needed to get onto the US market.
Since then Shield has signed a significant licencing deal to sell the drug in mainland Europe, and the news of the FDA approval saw shares jump to 178p, having fallen to lower than 30p at one point last year.
Carl Sterritt, CEO of Shield Therapeutics, said: “We are delighted that the FDA has approved the new drug application for our lead asset. This is a further major milestone for the company which we have worked tirelessly to achieve, and I am very proud to lead the team within Shield that has made this happen.
“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.
“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.”
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Last September, Shield received an £11m up-front licence payment from European pharma firm Norgine in exchange for the rights to sell its iron deficiency drug Feraccru in mainland Europe.
Now it is in talks with a number of potential commercial partners in America, where it said there were between 8m and 9m patients with iron deficiency anaemia, and potentially two to three times as many people who need treatment for iron deficiency.
Jackie Mitchell, Shield’s vice president for regulatory affairs, said: “The broad label that the FDA has granted provides a very strong signal as to the tolerability and efficacy profile of Feraccru/Accrufer and provides a novel and convenient treatment alternative to the millions of US patients who routinely suffer with iron deficiency.
“We believe that this broad approval, together with the recent clinical trial data on Feraccru that showed it to be non-inferior in treatment effect to Ferinject/Injectafer, the leading IV iron therapy, can lead to a change in the current paradigm for the treatment iron deficiency anaemia.”