Evidence from clinical studies shows it provides long-term treatment for maintaining the body’s iron stores. In our view, these factors provide a solid support for negotiating attractive deal terms.
Emma Ulker, Proactive Research
What Shield does
Its lead asset, Feraccru (Accrufer in the States), is an oral treatment for iron deficiency with or without anaemia, which is approved in Europe and the US.
The US opportunity alone could be worth in excess of US$1bn, analysts reckon.
A deal with ASK Pharm (Beijing Aosaikang Pharmaceutical), covers China, Hong Kong, Macau and Taiwan to market Ferracru.
The drug 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
How it is doing
In August, a reanalysis of the AEGIS-H2H study comparing oral Feraccru /Accrufer against intravenous iron therapy confirms Shield's product is a credible alternative to IV therapy for iron deficiency anaemia, and, corrects anaemia and maintains iron levels over the long term.
In July it announced it would take kidney disease treatment forward to phase III study, potentially starting in 2022 subject to finance being available. Hyperphosphatemia is a condition where due to renal failure there is too much phosphorus present in the blood.
Shield said that the study demonstrated that PT20 treatment for 28 days resulted in a statistically significant and dose-dependent reduction in serum phosphate concentration and was generally well tolerated.
What the boss says: Tim Watts, chief executive
"We are very pleased that the reanalysis of the AEGIS-H2H study data demonstrates that Feraccru/Accrufer is a credible alternative to IV therapy and offers economic advantages."
“Having resolved the anomalies seen in the original analysis the study results can now be used with confidence for further health economics analysis and to support pricing and reimbursement applications in Europe."
What the broker says
House broker Peel Hunt said in August the new findings on its Feraccru /Accrufer will be beneficial to sign up of a partner for the US market, while they are also supportive of the existing EU and Chinese commercial partners’ marketing efforts.
“Feraccru’s comparable improvement in haemoglobin in the long-term data against IV, combined with its greater tolerability, significantly more convenient oral administration, and compelling economic benefits, constitutes a very strong marketing package for EU commercialisation partner Norgine to leverage into the market.”
“We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities,” analysts at Edison Group added.
“The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found.”
What the analyst says
"The outcomes of the analysis are strongly supportive of ongoing discussions for the global commercialisation, pricing and reimbursement of Feraccru. This includes supporting STX’s partner Norgine to negotiate on pricing and coverage decisions in the broader European markets as well for ASK Pharm, the company’s partner in China," said Proactive's analyst Emma Ulker.
"A licensing deal in the US for Accrufer can start to unlock the world’s largest iron replacement market which represents c70% of the estimated US$3bn value of the global market."