CORPORATE MEDIA RELEASE
FERACCRU® (FERRIC MALTOL), A NOVEL, EFFECTIVE AND WELL TOLERATED TREATMENT FOR IRON DEFICIENCY LAUNCHED IN THE UK BY NORGINE
London, UK, 5 December 2018. 09:00 BST / 10:00 CET. Feraccru®, a novel, effective and well tolerated treatment for iron deficiency (ID) with or without anaemia including treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD), is today launched in the UK by Norgine.2-3
Ferric maltol is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of absorption compared to salt-based oral iron therapies.1 Ferric maltol has been shown in clinical trials to be well-tolerated by patients, even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.2-3
Andy Crichton, General Manager Norgine UK & Ireland, said: “We believe that Feraccru® is an important treatment advance for those patients who have iron deficiency, including those suffering from inflammatory bowel disease, and we look forward to helping patients in need in the UK.”
Ferric maltol is indicated in the UK for adults for the treatment of ID, with or without anaemia. Ferric maltol should not be used in patients with IBD flare or in IBD-patients with haemoglobin (Hb) <9.5 g/dl.1
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Notes to Editors:
Feraccru® is available as capsules (30 mg). The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach. Treatment duration depends on the severity of the iron deficiency (ID), but generally at least 12 weeks of treatment are required. Feraccru® normalises and maintains Hb levels, limiting the need for intravenous (IV) iron treatment to patients with Hb levels <9.5g/dl. 1
Iron deficiency anaemia (IDA) is frequently seen in inflammatory bowel disease (IBD). Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. Feraccru® is not an iron salt, and iron can be absorbed from the ferric maltol molecule. As a result, it does not routinely cause the same treatment-limiting intolerance issues.2
In the randomised phase-3 AEGIS IBD clinical trial programme, the efficacy and tolerability of Feraccru® was assessed in the treatment of IDA in patients with IBD who had previously failed to respond, or had been intolerant to previous oral ferrous products (OFP) therapy. Feraccru® was shown to be effective and well-tolerated at both 12 and 64 weeks.2
On 19 September 2018, Norgine entered into an exclusive licence agreement with Shield Therapeutics plc for the commercialisation of Feraccru® in Europe, Australia and New Zealand.
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. Norgine specialises in gastroenterology, hepatology, cancer and supportive care. In 2017, Norgine’s total net product sales were EUR 345 million, up 17 per cent.
Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
About Shield Therapeutics plc
Shield is a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs. Shield’s clear purpose is to help patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives. The Group has a marketed product, Feraccru®, for the treatment of iron deficiency in adult patients with or without anaemia. Feraccru® has exclusive IP rights until the mid-2030s.
For more information please visit www.shieldtherapeutics.com.
1. Summary of Product Characteristics, Shield Pharmaceuticals March 2018. Available at: https://www.medicines.org.uk/emc/medicine/31722. Accessed November 2018.
2. Gasche C, et al. Inflamm Bowel Dis 2015;21(3):579–588.Gasche C, et al. Inflamm Bowel Dis 2015;21(3):579–588.Gasche C, et al. Inflamm Bowel dis 2015; 21 (3): 579-588 Available at https://www.ncbi.nlm.nih.gov/pubmed/25545376 Accessed November 2018
3. Schmidt C, et al. Aliment Pharmacol The 2016;44 (3): 259-270 Available at https://www.ncbi.nlm.nih.gov/pubmed/27237709 Accessed November 2018