New data show that high quality cleansing improves lesion detection during colonoscopy compared to adequate cleansing

CORPORATE MEDIA RELEASE

NEW DATA SHOW THAT HIGH QUALITY CLEANSING IMPROVES LESION DETECTION DURING COLONOSCOPY COMPARED TO ADEQUATE CLEANSING[i]

AMSTERDAM. The Netherlands, Saturday 21 April 2018. 11:00 AM BST/12:00 CET. Norgine B.V. today announced new data showing that there is a strong correlation between higher cleansing scores and increased polyp detection rate (PDR) and adenoma detection rate (ADR).

The adenoma detection rate (ADR) is one of the primary quality measures of colonoscopy and an indicator of the likelihood of subsequent patient colorectal cancer.

The data were presented at the European Society for Gastrointestinal Endoscopy (ESGE) 2018, oral presentation, OP251, 21 April 2018, 11:36 to 11:48 am.

This post hoc analysis determined the relationship between BBPS* scores and adenoma and polyp detection rates in patients who had identical scores in each of the three colon segments, using pooled data from three similarly designed Phase 3, multicentre, randomised trials: NOCT, MORA and DAYB.

Overall colon lesion detection rates	High-Quality (N=166)	Adequate (N=950)	Low-Quality (N=54)	Odds ratio High-Quality : Adequate (95% CI) [P-value]	Odds ratio Adequate : Low-Quality (95% CI) [P-value]
PDR, n (%)	91 (54.8)	396 (41.7)	22 (40.7)	1.60 (1.14-2.24) [0.0067]	0.90 (0.50-1.60) [0.7104]
ADR, n (%)	71 (42.8)	247 (26.0)	15 (27.8)	1.97 (1.39-2.80) [0.0001]	0.75 (0.39-1.43) [0.3829]
LR Analysis of Association between Uniform BBPS Score Group and PDR, P-value	0.0239
LR Analysis of Association between Uniform BBPS Score Group and ADR, P-value	0.0006

Table 1. PDR and ADR by uniform BBPS score

Similar results were shown with the use of the Harefield Cleansing Scale** – Higher Harefield Cleansing Scale Scores are associated with improved lesion detection: post hoc analysis of three randomised and central reader-assessed phase 3 clinical trials, oral presentation, OP249, 21 April 2018, 11:12-11:24 am.[ii]

Dr Cesare Hassan, Gastroenterology and Endoscopic Unit, Nuovo Regina Margherita Hospital, Roma RM, Italy said: “For the first time, the use of two independent, validated, cleansing scales demonstrate that higher segmental cleansing quality is associated with higher lesion detection rates. As a result, patients should use a high quality bowel cleanser to facilitate early detection and removal of abnormalities in order to prevent colorectal cancer.”

Colonoscopy is a vital screening procedure to detect and remove adenomas and polyps that could otherwise lead to colorectal cancer.

Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with over 447,000 new diagnoses every year.[iii] Colorectal cancer is largely preventable, with early detection being associated with a 90% cure rate.[iv]

*Boston Bowel Preparation Scale (BBPS) is a 10-point scale assessing bowel preparation after all cleansing manoeuvres are completed by the endoscopist.[v]

**Harefield Cleansing Scale is a robust, reliable, and consistent tool that has the potential to improve the effective standardization of bowel preparation assessment in both clinical and research practice.[vi]

Notes to Editors:

About MORA, NOCT AND DAYB PHASE III TRIALS

MORA study. A European study that compared PLENVU^®to MOVIPREP^® using a 2-day evening / morning split-dosing regimen and a 1-day morning only split-dosing regimen in adults. The study met both of its primary endpoints. When administered using either dosing regimen, PLENVU^® was as effective as MOVIPREP^®in achieving overall bowel cleansing success, and superior to MOVIPREP^® in achieving ‘high quality’ cleansing of the right colon using the Harefield Cleansing Scale (HCS).[vii]
NOCT study. A US study that compared PLENVU^® to a trisulfate bowel cleansing solution using a 2-day evening / morning split-dosing regimen in adults. Both primary endpoints were met. PLENVU^® was as effective as a trisulfate solution in achieving overall bowel cleansing success and ‘high quality’ cleansing of the right colon.[viii]
DAYB study. A European study that compared PLENVU^®to a sodium picosulfate and magnesium salt solution using a 1-Day day before split-dosing regimen in adults. The study met both primary endpoints. PLENVU^® was as effective as sodium picosulfate and magnesium salt solution at achieving overall bowel cleansing success and ‘high quality’ cleansing of the right colon.[ix]

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.

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.

Media Contact:

Isabelle Jouin, T: +44 (0)1895 826237

GL/PLV/0418/0059

References:

[i] Hassan C. et al. High-quality cleansing improves lesion detection during colonoscopy compared to adequate cleansing: post hoc analysis of 1170 central-reader assessed patients in three randomised phase 3 trials. Oral Presentation. ESGE 2018

[ii] Manning J. et al. Higher Harefield cleansing scale scores are associated with improved lesion detection: post hoc analysis of three randomised and central reader-assessed phase 3 clinical trials. Oral presentation. ESGE 2018

[iii] Epidemiology of colorectal cancer in Europe. Source: GLOBOCAN 2012

[iv] American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html. Accessed 10 April 2018

[v]Edwin J. Lai et al. The Boston Bowel Preparation Scale: A valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar; 69(3 Pt 2): 620–625

[vi] Halphen M.^.Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013 Jul;78(1):121-31. doi: 10.1016/j.gie.2013.02.009. Epub 2013 Mar 24

[vii] Bisschops R, et al. P0179. 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. UEG Journal 2016; 4(5S): A218 – A219.

[viii] DeMicco MP, Clayton LB, Pilot J et al. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc 2017; 87(3):677-687

[ix] Schreiber, et al. P1266. Efficacy and safety of the novel 1L 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(5S): A589-A590