London. Tuesday 27 October 2015, 11:30 GMT. Norgine B.V. today presented at United European Gastroenterology Week 2015, three ongoing multicentre randomised parallel group phase III studies in 1914 patients undergoing colonoscopy investigating NER1006. The studies are NOCT, MORA and DAYB.[1]
The NOCT study compares NER1006 versus a trisulfate bowel cleansing solution (SUPREP®) using a 2-day split-dosing regimen in adults. The MORA study compares NER1006 versus MOVIPREP® using a 2-day split-doing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study compares NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults.
The findings from these pivotal phase III studies may provide a better understanding of what is required in an optimal bowel preparation, as the quality of bowel preparation is an important factor for a successful colonoscopy.
Peter Martin, Norgine’s Chief Operating Officer, said; “Norgine is pleased to be presenting the NER1006 phase III study programme at UEG Week 2015. The development of NER1006 further demonstrates Norgine’s commitment to improving outcomes for patients with colon cancer.”
Topline results for NOCT were recently announced, complete results from the study will be submitted to a scientific meeting in 2016. MORA and DAYB are expected to report in 2015. NER1006 is not approved for use.
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Notes to Editors:
About NER1006
NER1006 is a novel, low volume 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 Norgine
Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2014, Norgine’s total revenue was €296 million and the company employs over 1,000 people.
Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.
Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales, and one in 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.
Media Contacts:
Isabelle Jouin, T: +44 (0)1895 453643
Charlotte Andrews, T: +44 (0)1895 453607
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Job code: GL/COR/1015/0053
October 2015
References
[1] New Low-Volume Bowel Cleansing Solution (NER1006) vs Trisulphate, Polyethylene Glycol 3350+Ascorbate or Sodium Picosulphate/Magnesium Salt: Three Ongoing Multicentre Randomised Parallel Group Phase III Studies in 1914 Patients Undergoing Colonoscopy. Abstract: 15-ABS-3387