PLENVU® (NER1006) the First 1 Litre Bowel Preparation to Show Superior High-quality Segmental Cleansing of the Colon Compared to Standard of Care

AMSTERDAM, October 22, 2018 /PRNewswire/ --

Norgine B.V. today presented new data at the United European Gastroenterology Week which show that for the first time, PLENVU(R) (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) delivers superior, high quality segmental cleansing efficacy compared to MOVIPREP(R), SUPREP(R) and CitraFleet[(R)i].

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This post hoc analysis compared the level of high-quality segmental cleansing attained by PLENVU(R) versus its comparators MOVIPREP(R) (2L PEG + Ascorbate), SUPREP(R) (Oral Sulfate Solution) and CitraFleet(R) (Sodium Picosulfate + Magnesium Citrate), using data from three Phase 3, multicentre, randomised trials: NOCT, MORA and DAYB.[ii],[iii],[iv]

[Table 1. Colon segments with Harefield Cleansing Scale score 3-4 (high-quality), per treatment, in three central reader-assessed phase 3 trials]


Phase 3 trial DAYB MORA NOCT
Sodium
Picosulfat Oral
e+ Mg 2L PEG+ Sulfate
NER1006 Citrate NER1006 NER1006 Ascorbate NER1006 Solution
Split dosing
regimen PM/PM AM/PM PM/AM AM/AM PM/PM PM/AM PM/AM
FAS: Patients,
N 258 257 283 283 283 310 311
FAS:
High-quality
segments, n 218/1290 653/1415 662/1415 621/1550
(%) [P vs (16.9) 134/1285 (46.1) (46.8) 411/1415 (40.1) 563/1555
comparator] [P<0.001] (10.4) [P<0.001] [P<0.001] (29.0) [P=0.013] (36.2)
mFAS:
patients, N 250 251 275 275 272 276 280
mFAS:
High-quality
segments, n 218/1250 653/1375 662/1375 621/1380
(%) [P vs (17.4) 134/1255 (47.5) (48.1) 411/1360 (45.0) 563/1400
comparator] [P<0.001] (10.7) [P<0.001] [P<0.001] (30.2) [P=0.005] (40.2)
Per-Protocol:
Patients, N 172 207 220 218 232 233 239
Per-Protocol:
High-quality
segments, n 158/860 536/1100 552/1090 568/1165
(%) [P vs (18.4) 111/1035 (48.7) (50.6) 377/1160 (48.8) 526/1195
comparator] [P<0.001] (10.7) [P<0.001] [P<0.001] (32.5) [P=0.011] (44.0)
FAS, Full Analysis Set. mFAS, modified Full Analysis Set (FAS excluding
patients who failed lab screening after randomisation and who also failed to
take their study treatment). Per-Protocol (FAS with fulfilled entry criteria,
who took greater than or equal to75% of both study preparation doses, had data
for at least one of the primary endpoints, and no major protocol deviations).


Prof. Alessandro Repici,. Humanitas Hospital, Milan, Italy said: "These new data are significant because they demonstrate that PLENVU(R) provides superior high-quality colon cleansing efficacy to commonly used alternatives. High quality cleansing is associated with higher lesion detection rates; therefore, patients should use a high quality bowel cleanser to facilitate early detection and removal of abnormalities in order to prevent colorectal cancer."

He added: "By reducing the amount of bowel preparation volume, PLENVU(R) may improve patient experience and adherence to bowel cleansing instructions. Improved adherence to bowel preparation is known to reduce the need for repeat colonoscopy procedures, thereby reducing healthcare costs."

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

PLENVU(R) is available in Austria, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, The Netherlands, Norway, Portugal, Spain and the UK via Norgine and in the US via its partner Salix Pharmaceuticals. Norgine is anticipating further launches in 2018.

i. Repici A., Amlani B., Uebel P., Schreiber S. Superior high-quality colon cleansing with 1L NER1006 versus sodium picosulfate + magnesium citrate, 2L polyethylene glycol + ascorbate, or oral sulfate solution: Post hoc pooled analysis of three randomised phase 3 clinical trials. #P0159. Monday 22 October. 12:30 - 13:30 CET. UEGW 2018

ii. DeMicco MP, 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. 2018: 87(3):677-687

iii. Bisschops R, et al. Colon cleansing efficacy and safety with 1L NER1006 versus 2L polyethylene glycol + ascorbate: a randomized Phase 3 trial. ENDOSCOPY. https://doi.org/10.1055/a-0638-8125 [https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-0638-8125 ]

iv. Schreiber, et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy 2019; 51: 1-16 https://doi.org/10.1055/a-0639-5070

v. Epidemiology of colorectal cancer in Europe. Source: GLOBOCAN 2012

vi.  American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/de tection.html. Accessed 10 April 2018

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Media contact: Isabelle Jouin; +44-189-582-6237



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