London. Friday 9 October 2015, 07:00 AM BST. Norgine today announced positive top line results for its phase III study, NOCT, a multicentre, randomised, parallel-group clinical trial comparing the bowel cleansing efficacy of a two-day split-dosing regimen of NER1006, versus a split-dosing regimen of a trisulfate bowel cleansing solution (SUPREP®) in adult patients undergoing screening, surveillance or diagnostic colonoscopy. The NOCT study also assessed the compliance, safety, patient acceptability and tolerability of NER1006.
The NOCT study, which enrolled 621 patients, met both of its primary endpoints.
Peter Martin, Norgine’s Chief Operating Officer, said; “These positive top-line results demonstrate the potential of NER1006 as a novel bowel cleansing agent to deliver an effective colonoscopy. These data are encouraging as a major milestone on the development of this novel bowel cleansing agent”.
The NOCT study is part of Norgine’s NER1006 Phase III clinical trials programme. The programme includes two additional multicentre, randomised, parallel-group clinical trials, MORA and DAYB, that are expected to report in 2015.
Full evaluation of the data is ongoing. Complete results from the NOCT study will be submitted to a scientific meeting in 2016. NER1006 is not approved for use.
Notes to Editors:
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.
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.
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Isabelle Jouin, T: +44 (0)1895 453643
Charlotte Andrews, T: +44 (0)1895 453607
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GL/COR/1015/0049. October 2015