Norgine's PLENVU® (NER1006) Receives Belgium and Denmark Approval for Bowel Cleansing in Adults Prior to Any Procedure Requiring a Clean Bowel

- Norgine B.V. today announced that the Federal agency for medicines and health products and the Danish Medicines Agency have granted marketing authorisation for PLENVU® (NER1006) for bowel cleansing in adults prior to any procedure requiring a clean bowel. The approval was granted under the European Medicines Agency decentralised procedure, with the UK as reference state. Norgine anticipates further marketing approvals in Q4 2017 and 2018.      (Logo: http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg ) PLENVU® will be launched in early 2018 in Belgium and Denmark. PLENVU® is already available in the UK. PLENVU® is a novel, low volume (1-litre) polyethylene glycol (PEG) 3350-based bowel preparation that has been developed by Norgine to provide whole bowel cleansing, shown to be superior in providing high-quality cleansing in the colon ascendens, an important area for adenoma detection.[2] The approval was based on data from the Phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies: Norgine manufactures PLENVU® and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world. References [1] Bisschops R, et al. P0179. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus standard 2L PEG with ascorbate in overnight or morning split-dosing administration: results from the phase 3 study MORA. UEG Journal 2016; 4(5S): A218 - A219. [2] Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754. Media Contact:Isabelle Jouin, T: +44(0)1895-453643 Follow us @norgine