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Shield Therapeutics wins extended approval for Feraccru in Switzerland

The company is encouraged by progress being made with regulatory authorities ahead of an expected decision from US regulators in late July
Switzerland has a much higher level of treatment penetration for iron therapies

Shield Therapeutics PLC’s (LON:STX) shares rose on Wednesday following news Switzerland’s medical authorities have given approval for its Feraccru iron deficiency drug to be given to all adults with iron deficiency.

Following the decision by the Swiss Agency for Therapeutic Products, the company will be able to market the drug to any adult, whether or not they have been diagnosed with anaemia.

READ: Shield Therapeutics' shares rise as it hails results of extended trial of Feraccru

With Feraccru last year granted similar approval across the European Union, Shield chief executive Carl Sterritt was encouraged by the progress being made with regulatory authorities, especially as he expects a big decision from the US drug regulator in late July.

“Switzerland represents an attractive market opportunity as it is both well reimbursed and has a much higher level of treatment penetration compared to other markets, particularly for IV iron therapies,” he said.

The combination of the Swissmedic extension and the recent results of a year-long clinical study that showed pill-form Feraccru to be just as good as the current standard of care treatment in boosting users’ haemoglobin. Sterritt said it will provide “an enhanced commercial opportunity” to Ewo, Shield’s Swiss commercial partner. 

“We look forward to working with them to deliver commercial success for Feraccru in Switzerland at the earliest opportunity."

Positive progress highlighted

In a note to clients, analysts at ‘house’ broker Peel Hunt pointed out: “Today’s announcement follows an equivalent broadening of the marketing authorisation approval for Feraccru in the European Union in 2018 and further increases the commercial opportunity for Feraccru across Europe.”

They added; “This news does not affect our estimates or valuation for Shield, but highlights the positive progress at the company and the growing commercial opportunity for Feracrru.

“As a reminder, the next catalyst for the company will be the FDA’s decision on whether to grant marketing approval for Feraccru in the US, due 27 July 2019.”

 Peel Hunt repeated a  ‘buy’ rating and 88p price target on Shield shares, which in late morning trading were 3.6% higher at 86.50p.

 -- Adds analyst comment, share price --

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