Alongside the financial terms of the licence, the agreement sees ASK Pharm undertaking and paying for all activities to achieve marketing authorisation and then commercialising Feraccru/Accrufer in the Territory.
Shield will receive an upfront payment of
Based in
We look forward to updating the market on progress with ongoing discussions relating to the commercialisation of Feraccru/Accrufer in the US. As previously indicated the priority is to secure a highly motivated partner on attractive commercial terms rather than completing the process to a particular deadline.'
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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 salt and, 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 state that iron deficiency is the most common and widespread nutritional disorder in the world. As well as affecting a large number of children and women 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, so using anaemia as an indirect indicator it can be estimated that most preschool children and pregnant women in non-industrialized countries, and at least 30-40% in industrialized countries, are iron deficient.
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