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Shield Therapeutics PLC

Shield Therapeutics primed for a busy year

Snapshot

Here we take a look under the hood of Shield Therapeutics

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Quick facts: Shield Therapeutics PLC

Price: £1.81

Market: LSE
Market Cap: £212.11 m
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  • Has an approved iron deficiency drug
  • US approval pending 
  • Late-stage treatment for an electrolyte disorder
  • Multiple inflexion points 

What the Company Does

Shield Therapeutics PLC (LON:STX) is a specialty pharmaceutical company focused on the development and commercialisation of late-stage pharmaceuticals. Its lead asset, Feraccru, is an oral treatment for iron deficiency with or without anaemia. Feraccru is approved and marketed in Europe, with a US approval decision pending for July 27. It also has a pipeline of prescription pharmaceutical 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 Therapeutics heading for a US approval decision

Feraccru has a range of features that help differentiate it from the more established iron treatments including:

• Twice-daily dosing without food providing high iron availability

• Raises haemoglobin and iron levels effectively

• Prolonged therapy maintains Hb levels

• Well tolerated

• Non-inferior to IV iron

• Feraccru is a stable, non-salt, oral formulation of ferric iron, which has a unique mechanism of action compared to salt-based oral iron therapies

Inflexion Points

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.

• Further news on commercialisation progress, publication of peer-reviewed Feraccru data from H2H study

• US PDUFA date 27 July (this is the deadline by which regulators must review new drugs)

• Initiation of a paediatric study in infants over one-month, starting in the second half of 2019

• News on next steps with PT20 including outcomes of ongoing reformulation work

• News on partnering in new geographies – notably China in next 12 months

Blue Sky

The market leading IV iron delivered FY18 in-market revenues of US$898mln in a global IV iron market valued at US$1.8bn. Vifor Pharma AG, a Switzerland-based company with a market capitalisation of US$8.5bn commercialises the market leading branded intravenous iron, Ferinject, known as Injectafer in US.

“We contend that Feraccru can command a high market share as well as branded pricing because of its convenience and, supported by emerging evidence from clinical studies, that it provides a long-term treatment for maintaining the body’s iron stores,” said Emma Ulker, analyst at Capital Network. “Its convenience is a very important differentiator as patients can take Feraccru at home, avoiding a hospital admission and the life-threatening risks of IV iron administration. Physicians report that the outcomes seen in clinical studies are reflected in real world use of Feraccru.”

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Watch

Shield Therapeutics 'in a strong position' and confident of a US Feraccru deal

Shield Therapeutics (LON:STX) chief financial officer Tim Watts talks Proactive London's Andrew Scott through their first half update to June 2019. ''If you consider where we've been over the last 12 months we're in a far, far stronger position now and with the US approval of Feraccru we're...

on 8/8/19

3 min read

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