Proactive Investors - Run By Investors For Investors

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.

 
Full report is available via Capital Network website
View full STX profile View Profile

Shield Therapeutics PLC Timeline

Related Researches

no_picture_pai.jpg
July 30 2018

Avacta Group Plc (LON:AVACT) has recently finalised a co-development partnership with Boston-based Bach BioSciences, to exploit the potential of the Affimer platform for the development of a novel class of drug conjugates.

no_picture_pai.jpg
April 09 2019

  • Avacta Group PLC (LON:AVCT) reported interim results to January 2019, confirming good progress on key development programmes
  • Lead immune checkpoint inhibitor programmes continue to move towards in-man clinical data in 2020
  • Major development partnership and licence agreement with LG Chem potentially worth more than US$300mln plus royalties, announced in December
  • Post-period end, the additional licensing deal with Moderna provides further validation of Avacta’s Affimer platform
  • Appointment of Jose Saro as the chief medical officer strengthens Avacta’s capabilities for evolving from pre-clinical to clinical
  • The Research and Diagnostic Reagents business reports a record sales pipeline

Avacta (LON:AVACT) reported revenues of £1.0mln, down from £1.5mln the year before, largely due to the absence of research services revenues for FTEs working on the Moderna collaboration now that assets have been transferred into their development pipeline. We expect revenues from the LG Chem deal to offset this during the remainder of 2019.

The company reported a cash outflow from operations of £2.9mln and ended the period with £11.8mln net cash following the £11.6mln fund-raise in August. We believe that Avacta can comfortably fund ongoing development programmes into 2020.

The company will be moving its year-end from July to December, meaning that the current year will be reported on the basis of a

17-month period (see table below).

no_picture_pai.jpg
January 18 2019

Feraccru is a unique, non-salt, formulation oral iron: strong efficacy with “placebo-like” tolerability

Potential to change iron deficiency anaemia (IDA) therapeutic algorithm

Feraccru to become the preferred option for patients not adequately controlled or who are intolerant to generic oral iron supplements (before they switch to intravenous iron).

With an indication in Europe to treat iron deficiency, Feraccru’s use would prevent the occurrence/reoccurrence of iron deficiency anaemia

Feraccru European commercialisation expected to accelerate significantly following the licensing agreement with Norgine announced in September 2018

Key upcoming milestones: results of the head-to-head phase 3 study of Feraccru vs intravenous (i.v.) iron expected in first half (1H) of 2019; Feraccru PDUFA (Prescription Drug User Fee Act) date 27 July 2019

Current market capitalisation of about £40mln is by and large not reflecting Feraccru commercial potential

Copyright © Proactiveinvestors.com, 2019. All Rights Reserved - Proactive Investors North America Inc., Proactive Investors LLC

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use