Operational highlights
FDA approved Accrufer with a broad label for treating iron deficiency in adults
Positive long term data from AEGIS-H2H (head-to-head) clinical study comparing Feraccru/Accrufer to IV iron although the study did not meet its primary end point at 12 weeks
The H2H study demonstrated that Feraccru/Accrufer offers a simple, well tolerated and efficacious oral treatment alternative to IV iron therapy, without the need for hospital-based administration
Long term phase of AEGIS-CKD study shows haemoglobin levels increased and maintained across 52 weeks of Feraccru therapy in patients with chronic iron deficiency anaemia (IDA)
Swissmedic approved Feraccru to treat iron deficiency with or without anaemia in adults
Financial highlights
Revenues of
Loss for the year of
Net cash of
Post-period highlights
Exclusive licence agreement with
Deal highlights
Up to
Ongoing tiered double-digit royalties on net sales payable to Shield
ASK Pharm to be responsible for, and cover costs of, all development and regulatory activity
Agreed to repay
Commenting on the preliminary results,
Contact:
Tel: +44 (0)20 7186 8500
Web: www.shieldtherapeutics.com
About
Shield is a de-risked, commercial stage, specialty pharmaceutical company delivering innovative pharmaceuticals to address patients' unmet medical needs. The Company's clear purpose is to develop products that help patients become people again, enabling them to enjoy the things that make a difference in their everyday lives. The Group's lead product, Feraccru/ Accrufer has exclusive IP rights until the mid-2030s and is approved for the treatment of iron deficiency with or without anaemia in adults in the
About Feraccru /Accrufer
Feraccru /Accrufer is a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia that has been shown to be an efficacious and well-tolerated therapy in a range of controlled phase 3 trials, including positive results from the Phase IIIb AEGIS-H2H study in which Feraccru/Accrufer demonstrated it was non-inferior in delivering improvements in haemoglobin levels compared to intravenously-administered (IV) Ferinject/Injectafer (ferric carboxymaltose). Feraccru/Accrufer therefore offers a compelling alternative to IV iron for those patients unable to tolerate salt-based oral iron therapies and wish to avoid the complexities of infusion-based iron therapies.
When salt-based oral iron therapies are ingested they can cause a range of mild-to-severe gastrointestinal tract (GI) adverse events, including nausea, bloating and constipation through the release and subsequent reactivity of free iron in the GI tract, leading to poor tolerability, reduced patient compliance and ultimately treatment failure. Feraccru/Accrufer is not an iron saltand, as a result, it does not routinely cause the same treatment-limiting intolerance issues of salt-based iron therapies, whilst the iron from the ferric maltol molecule can be readily absorbed.
Prior to Feraccru /Accrufer, IV iron therapies were the only realistic alternative treatment option for iron deficient patients with or without anaemia intolerant of or unwilling to be treated salt-based oral iron therapies. However, use of such an invasive, costly, inconvenient and complex to administer treatment option, which is associated with potentially life-threatening and spontaneous hypersensitivity reactions, means there remains a clear unmet medical need for these patients to have access to an effective therapy that is well tolerated, convenient and does not require hospital-based administration. Feraccru/Accrufer meets those requirements.
About Iron Deficiency
The WHO states that iron deficiency is the most common and widespread nutritional disorder in the world. As well as affecting a large number of women and children in non-industrialized countries, it is the only nutrient deficiency which is also significantly prevalent in virtually all industrialised nations. There are no current global figures for iron deficiency but, using anaemia as an indirect indicator, it can be estimated that most preschool children and pregnant women in non-industrialised countries, together with at least 30-40% in industrialized countries, are iron deficient.
Forward-Looking Statements
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. The forward-looking statements made in this press release represent management's expectations as of the date of this press release, and except as required by law, the Group disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.
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