London - Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru/Accrufer (ferric maltol), provides an update on its plans to commercialise Accrufer in the USA and its cash position.

US commercialisation

Accrufer was approved in July 2019 by the FDA for the broad indication of treatment of iron deficiency in adults. Since then Shield has conducted an extensive process to identify and appoint a commercialisation partner for the US market and, through this process, the Group and its advisers have engaged with a wide range of interested parties. Since this process began Shield has received numerous indicative proposals from potential commercialisation partners and, whilst some of these reached late stages of negotiation, they did not proceed to completion due to adverse business events specific to the counterparties concerned and unrelated to Accrufer. The Group remains in discussions with a number of potential commercialisation partners for the US marketing rights to Accrufer but it is now clear that a transaction will not be completed before the end of 2020.

The length of time that the process has taken and the late-stage setbacks incurred have been frustrating for both the Board and shareholders but Shield's understanding of the US iron therapy market has developed significantly over the last year, and the market itself has also evolved in that time, in large part due to the COVID pandemic. Discussions with potential commercialisation partners have demonstrated to Shield that it is realistic for companies without large sales and marketing infrastructure to launch a product such as Accrufer in the US. The COVID pandemic has accelerated the trend towards greater reliance on telesales, e-detailing and on-line marketing, reducing the need for very large sales teams. The COVID pandemic has also accentuated some of the advantages that Accrufer, a well-tolerated and effective oral treatment, offers 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. Furthermore, Shield believes that the first US launch of an oral HIF inhibitor(1) for chronic kidney disease (CKD) patients, anticipated in Q1 2021, is likely to increase the need for effective and well tolerated oral iron replacement therapy.

The Board has therefore concluded that, in order to maximise the Group's options, in parallel with continuing ongoing discussions with potential licence partners it should explore the potential launch of Accrufer in the US by Shield, possibly including co-promote and/or sub-licence partners in specific therapeutic areas. To this end, work is being carried out with US-based consultants and other advisers to develop a strategy and plans for a Shield-led launch. A key component of this planning is to establish the investment needed for such a launch. Shield estimates that the amount required for the Group to reach the point at which it generates cash, including the US launch costs, the costs of Shield's current non-US operations and the ongoing paediatric study is in the range of $30 million to $40 million. The Company expects that any financing for a Shield led US launch of Accrufer would include a substantial debt component and Shield is in discussions with several potential lenders and has already received a number of term sheets on acceptable commercial terms.

The Group is continuing to progress both the out-licence and Shield-led launch opportunities and will decide which of the alternatives is likely to deliver greater value to shareholders, taking into consideration the potential financial returns from each alternative, and their respective risks.

Contact:

Tim Watts

Tel: +44 (0)20 7186 8500

Web: www.shieldtherapeutics.com

About Shield Therapeutics plc

Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru/Accrufer, a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. Feraccru/Accrufer has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s. Feraccru is commercialised in the UK and Europe by Norgine B.V. and the Company is currently in the process of selecting a commercialisation partner for the US market. Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of Feraccru/Accrufer in China, Hong Kong, Macau and Taiwan.

(C) 2020 Electronic News Publishing, source ENP Newswire