US commercialisation
Accrufer was approved in
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
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:
Tel: +44 (0)20 7186 8500
Web: www.shieldtherapeutics.com
About
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
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