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.
On July 26 the Food & Drug Administration (FDA) awarded the treatment a broad label to treat iron deficiency in adults, addressing a population many times wider than the iron-deficiency anaemia indications included in the submission data.
There are around three times as many patients with iron deficiency than with iron deficiency anaemia. That means the total addressable population could reach up to 40mln in the US, according to Proactive Research’s Emma Ulker.
It is also now positioned to directly challenge the market-leading intravenous (IV) iron therapy following a study that showed Feraccru was at least as efficacious as the standard treatment.
“Shield is therefore clearly on a very strong footing to advance its discussions with commercial partners for Accrufer based on this broad approval as well as a very sound data package,” said Ulker in a recent research note.
The US opportunity alone could be worth in excess of US$1bn, analysts reckon.
In January, Shield signed an exclusive agreement worth up to US$63mln for Feraccru to be sold in China.
The deal with ASK Pharm (Beijing Aosaikang Pharmaceutical), covers China, Hong Kong, Macau and Taiwan and will involve an upfront payment of US$11.4mln and up to US$51.4mln in milestone and royalties.
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's doing
In May, Shield said talks to find a partner for the product in the US (where it is known as Accrufer) are ongoing with significant interest from a range of companies.
Sales of Feraccru in Germany and the UK rose during the first quarter of 2020, according to the firm's European partner Norgine, though Shield noted this was before the full impact of the pandemic became clear.
Revenues in 2019 are expected to be £0.7mln.
The group's cash balance at March 31 was £11.3mln with the company’s runway extending currently into the first quarter of 2021.
What the boss says: Tim Watts, chief executive
"I am reassured that despite the current challenges presented by the global pandemic we continue to operate effectively and there has been little disruption to our commercialisation plans.
"We are encouraged by the continued interest from potential US partners during uncertain times, confident of the pressing need for our product as an effective alternative treatment for iron deficiency, and remain committed to advancing commercial discussions to secure the best deal for shareholders."
What the analyst says
Proactive Research's Emma Ulker on the prospects for a US deal said; "Accrufer is positioned to command a high market share because of its convenience, favourable clinical evidence and side effect profile. STX is progressing towards an agreement that can unlock this key market, and is in the process of scaling-up production of Accrufer ahead of this event."