LONDON, October 9, 2015 /PRNewswire/ --
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.
(Logo:
http://photos.prnewswire.com/prnh/20130829/633895-a )
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:
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 http://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 http://www.norgineventures.com.
NORGINE and the sail logo are trademarks of the Norgine group of
companies.
GL/COR/1015/0049. October 2015
Media Contacts:
Isabelle Jouin, T:
+44(0)1895-453643
Charlotte Andrews, T:
+44(0)1895-453607
Follow us @norgine