Publicado 04/03/2019 13:09
- Comunicado -

Important New Trial With Oral FERACCRU Shows Comparable Efficacy to IV Iron (Ferric Carboxymaltose), Offering a Real Al

Shield is a de-risked, commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs. The Company's clear purpose is to help its 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 adults which has exclusive IP rights until the mid-2030s. Feraccru is commercialised in the European Union by Norgine BV and the US Food and Drug Administration (FDA) is currently considering a New Drug Application (NDA), with a PDUFA (Prescription Drug User Fee Act) date of 27th July 2019. For more information please visit www.shieldtherapeutics.com [http://www.shieldtherapeutics.com/].

References

1. Summary of Product Characteristics, Shield Pharmaceuticals March 2018. Available at: https://www.medicines.org.uk/emc/medicin... [https://www.medicines.org.uk/emc/medicin...] Accessed March 2019 2. Gasche C, et al. Inflamm Bowel dis 2015; 21 (3): 579-588 Available at https://www.ncbi.nlm.nih.gov/pubmed/2554... [https://www.ncbi.nlm.nih.gov/pubmed/2554...] Accessed March 2019 3. Schmidt C, et al. Aliment Pharmacol Ther 2016;44 (3): 259-270 Available at https://www.ncbi.nlm.nih.gov/pubmed/2723... [https://www.ncbi.nlm.nih.gov/pubmed/2723...] Accessed March 2019 4. Shield Study ST10-01-304 Headline Results 4th March 2019: "A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous ferric carboxymaltose, for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease" 5. Biancone et al. J Crohn's and Colitis 2008; 2: 63-92. 6. Ferinject SmPC November 2018 https://www.medicines.org.uk/emc/product... [https://www.medicines.org.uk/emc/product...] 7. Lugg et al. 2014 Journal of Crohn's and Colitis 8, 876-880

Date of preparation March 2019

(Logo: https://mma.prnewswire.com/media/597589/... [https://mma.prnewswire.com/media/597589/...] )

CONTACT: For an interview with Dr Alastair Benbow, Chief Medical andDevelopment Officer at Norgine or further information about the trialresults, please contact: Clara Bentham +44 (0)1895 826654 or +44 (0)7734367883, Eleni Fistikaki +44 (0)1895826227 or +44 (0)7825389477,contact@norgine.com

Contenido patrocinado