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CORPORATE MEDIA RELEASE
NORGINE PRESENTS NEW POST-HOC DATA ANALYSES HIGHLIGHTING THE EFFICACY OF PLENVU® FOR BOWEL CLEANSING AT DDW
London, UK. Saturday 6 May 2017. 18:00 BST. Norgine B.V. today presented new post-hoc analyses from the phase III DAYB and MORA studies that demonstrate the high-quality cleansing efficacy of PLENVU®, a low volume, 1 litre PEG and ascorbate bowel preparation when compared to sodium picosulfate with magnesium citrate (CITRAFLEET®) and 2 litre PEG with ascorbate (MOVIPREP®) respectively when using site colonoscopist assessments., In addition, data from the DAYB study show that PLENVU® achieved statistically significant improvements in adequate cleansing rates using the Boston Bowel Preparation Score when compared to sodium picosulfate with magnesium citrate.
High cleansing efficacy:
Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate;
Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented “These phase III data confirm the potential of PLENVU®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources.”
These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago.
The PLENVU® Phase III clinical trial programme includes three multicentre, randomised, parallel group studies: NOCT, MORA, and DAYB.
PLENVU® data being presented at DDW on Saturday 6 May, 12:00 CDT
In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for PLENVU® in the US and Canada.
PLENVU® is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US.
Notes to Editors:
About PLENVU® (NER1006
PLENVU® (NER1006) is a novel, low volume (1L) polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. This low-volume solution is developed not only to support improved patient acceptability and compliance but also to contribute to effectiveness of colonoscopy procedures at detecting colon cancer and for optimised bowel surveillance, through effective bowel cleansing.
About the phase III clinical trial programme
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total revenue was EUR 368 million. 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.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
For more information, please visit www.norgine.com
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.
Isabelle Jouin, T: +44 (0)1895 453643
Charlotte Andrews, T: +44 (0)1895 453607
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 Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017
 Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017
 Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017
 Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 – A219
 DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(Suppl1): A415-A416
 Schreiber, et al. P1266 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus sodium picosulfate + magnesium citrate in day before split dosing administration: results from the phase 3 Study DAYB. UEG Journal 2016; 4(Suppl1): A589-A590
 Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915