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Shield Therapeutics updates on commercialisation efforts for Accrufer in the US

Published: 08:04 10 Dec 2020 GMT

Shield Therapeutics PLC - Shield Therapeutics updates on commercialisation efforts for Accrufer in the US

Shield Therapeutics PLC (LON:STX) has updated investors on the status of its efforts to commercialise its Accrufer iron deficiency treatment in the US market.

The AIM-listed firm said that since Accrufer was approved by the Food and Drug Administration (FDA) in July 2019, it has conducted a process to identify and appoint a commercialisation partner for the US market and, through this process, it has engaged with a range of interested parties and received numerous indicative proposals from potential commercialisation partners.

READ: Shield Therapeutics says TEVA has withdrawn patent challenge

Shield said it remains in discussions with a number of potential commercialisation partners, although the company said it is now clear that a transaction will not be completed before the end of 2020.

To maximise its options, Shield said it will explore a self-led launch of Accrufer in the US, possibly including co-promotion and/or sub-licence partners in specific therapeutic areas, as well as continuing ongoing discussions with potential licence partners.

To this end, Shield said work is being carried out with US-based consultants and other advisers to develop a strategy and plans for a Shield-led launch, estimating that the amount required for the group to reach the point at which it generates cash, including US launch costs and the costs of its current non-US operations and an ongoing paediatric study, is in the range of US$30mln to US$40mln.

With a financing for a Shield-led US launch of Accrufer likely to include a “substantial debt component”, discussions with several potential lenders has already led to a number of term sheets being received on acceptable commercial terms.

While the length of time the process has taken being “frustrating”, management pointed out that the coronavirus pandemic has accentuated some of the advantages of Accrufer over intravenous (IV) iron replacement therapy as it avoids the need for patients, usually with underlying health issues, to visit hospitals or clinics to be infused.

The first US launch of an oral hypoxia-inducible factor (HIF) inhibitor for chronic kidney disease (CKD) patients, anticipated in the first quarter of 2021, is likely to “increase the need for effective and well tolerated oral iron replacement therapy” such as Accrufer.

Meanwhile, the group reported a cash balance of £3.8mln and has a cash runway until the second quarter of 2021, while two of the company’s shareholders, board member Christian Schweiger and AOP Orphan International AG, have agreed to lend Shield the equivalent of £4.4mln, extending the cash runway to the end of 2021.

"I am very grateful to AOP and Dr Schweiger for making loan facilities available to the group.

These will give us time to secure the best possible outcome for all shareholders. It is clear from our work over the last year, including market research and discussions with potential partners, that there is an exciting opportunity for Accrufer in the United States,” Shield chief executive Tim Watts said in a statement.

“Patients, prescribers and payers express the need for a well-tolerated and effective oral iron therapy as an alternative to IV iron replacement and older oral iron products. Although we continue to have attractive licence discussions, it is prudent that we also assess other options by which we can drive value for our shareholders and a Shield-led launch of Accrufer is a very credible alternative plan. The board remains very confident that either way we will secure an outcome which will generate substantial value for shareholders", he added.

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on 3/10/23