- 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.
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
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
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.”