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Shield Therapeutics PLC Heading for a US approval decision

Shield Therapeutics PLC Heading for a US approval decision

Shield Therapeutics (LON:STX) is making excellent progress having reported two sets of new supportive clinical data on its lead product Feraccru, a low dose oral iron capsule. Feraccru is being positioned as an alternative therapy for patients with iron deficiency (ID) and iron deficiency anaemia (IDA) unable to tolerate or unresponsive to first-line oral iron tablets and as an alternative to second line invasive intravenous (IV) iron.


  • New data from AEGIS H2H multi-national phase IIIb randomised, active-controlled trial, announced in March, showed non-inferiority to a market leader Ferinject. The latest head-to-head data is compelling and presents a clear commercial challenge to market incumbents.
  • The value of the iron replacement market is approaching $3bn, while Ferinject achieved FY18 in-market sales of CHF 900m in a global IV iron market worth $1.8bn, according to IQVIA. Sales in some geographies are growing at a double-digit rate. Feraccru’s convenience could lead to better compliance and improved penetration – growing the overall market size.

  • The positive outcomes triggered a €2.5m development milestone receivable from European/Australasia license partner Norgine out of total potential development and sales milestones of up to €54.5m over the life of the deal.

  • Phase III AEGIS CKD (chronic kidney disease) long-term follow-up study results announced in January showed that Feraccru’s long-term efficacy and tolerability was maintained at 52 weeks, having met the original primary endpoint at 16 weeks (announced in 2018). The study provided additional evidence of the maintained benefit with continued Feraccru therapy, a lack of relapse and therefore no requirement for IV iron.

  • We contend that Feraccru can command a high market share as well as premium pricing because of its convenience and supported by further evidence emerging from clinical studies that it provides a long-term treatment for maintaining the body’s iron stores, thereby preventing recurrence of IDA.

  • If the US approval decision is positive, Feraccru has a strong data package to support partnering discussions and facilitate commercial success. A late-stage asset such as Feraccru would likely command attractive royalties as well as upfront and commercial milestone payments.

  • Shield has a cash reach into Q320 on its end-December 2018 net cash position of £9.8m.

 
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Shield Therapeutics PLC Timeline

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