CORPORATE PRESS RELEASE
NEW POSITIVE PHASE III STUDY FOR NER1006 –
THE FIRST 1 LITRE PEG-BASED BOWEL PREPARATION
· Study met both primary endpoints demonstrating non-inferiority in overall bowel cleansing and superiority in ‘Excellent plus Good’ cleansing of the ascending colon
London, UK. Tuesday 24 May 2016, 17:30 BST. Norgine B.V. today announced new positive data from the phase III MORA study for NER1006 (1 litre PEG and ascorbate bowel preparation) versus standard 2 litre PEG with ascorbate. The study met both primary endpoints showing that when administered as either a 2-day overnight or 1-day morning split-dosing regimen, and compared to 2L PEG, NER1006 was:
· Non-inferior in achieving overall bowel cleansing
· Non-inferior and superior in achieving ‘Excellent plus Good’ cleansing of the ascending colon
In addition, the study showed that as a 2-day overnight or 1-day morning split-dosing regimen, NER1006 was non-inferior in detecting adenomas and polyps in the ascending and overall colon and as a 2-day overnight split-dosing regimen, it demonstrated a superior polyp detection rate in the ascending colon.
The overall tolerability and safety profile of NER1006 was comparable to that of 2L PEG. Treatment related adverse events were mild or moderate in severity and reflected the expected safety profile of the respective treatments.
The threshold for statistical significance in this study was P<0.025 and a 10% margin was used to demonstrate non-inferiority vs. 2L PEG. [1]
Peter Martin, Norgine’s Chief Operating Officer, said: “The new positive phase III MORA results for NER1006 are promising because we know that the quality of a bowel preparation is an important factor for a successful colonoscopy and detecting polyps and tumours. These data reinforce Norgine’s leadership in colonoscopy to provide patients with innovative treatments.”
NER1006 is not yet approved for use. Norgine intends to submit NER1006 for approval in the US and EU.
The data 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 was presented at Digestive Disease Week on 24 May 2016, 09:30-16:30.
Ends
Notes to Editors:
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
This phase 3, randomized, multicenter, colonoscopist-blinded, non-inferiority study assessed the efficacy, safety and tolerability of NER1006, administered either as a 2-day overnight (N2D) or 1-day morning (N1D) split-dosing regimen versus a 2L PEG3350 with ascorbate 2-day overnight split dosing regimen (2LPEG) in patients undergoing a colonoscopy.
Two alternative primary endpoints were evaluated: overall bowel cleansing efficacy and ‘Excellent plus Good’ cleansing rate in the colon ascendens using the Harefield Cleansing Scale (HCS). Secondary endpoints included hierarchical evaluation of lesion detection rates (key), and cleansing assessment using the Boston Bowel Preparation Scale (BBPS; supportive). Patient tolerability, acceptability and compliance were assessed using questionnaires.
Safety was monitored through adverse events and clinical laboratory evaluation.
The threshold for statistical significance in this study was P<0.025 and a 10% margin was used to demonstrate non-inferiority vs. 2LPEG.
About NER1006
NER1006 is a novel, low volume (1L) polyethylene glycol and ascorbate based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. NER1006 has a dual formulation containing an initial majority PEG dose followed by a majority ascorbate dose to maximise the overall effectiveness.
About Norgine
Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 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/0516/0067
May 2016
References
[1] Raf Bisschops, Jonathan Manning, Lucy Clayton, Richard Ng Kwet Shing, Marco A. Alvarez-Gonzalez (2016): 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. Gastroenterology, Vol. 150, Issue 4, S1269-S1270. Abstract Tu2084.