PLENVU® (NER1006) the first 1 litre bowel preparation to show superior high-quality segmental cleansing of the colon compared to standard of care

CORPORATE MEDIA RELEASE PLENVU® (NER1006) THE FIRST 1 LITRE BOWEL PREPARATION TO SHOW SUPERIOR HIGH-QUALITY SEGMENTAL CLEANSING OF THE COLON COMPARED TO STANDARD OF CARE[i] AMSTERDAM. The Netherlands. 22 October 2018. 11:30 BST / 12:30 CET. Norgine B.V. today presented new data at the United European Gastroenterology Week which show that for the first time, PLENVU® (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®, SUPREP® and CitraFleet®i. This post hoc analysis compared the level of high-quality segmental cleansing attained by PLENVU® versus its comparators MOVIPREP® (2L PEG + Ascorbate), SUPREP® (Oral Sulfate Solution) and CitraFleet® (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 NER1006 Sodium Picosulfate+ Mg Citrate NER1006 NER1006 2L PEG+ Ascorbate NER1006 Oral Sulfate 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 (%) [P vs comparator] 218/1290 (16.9) [P<0.001] 134/1285 (10.4) 653/1415 (46.1) [P<0.001] 662/1415 (46.8) [P<0.001] 411/1415 (29.0) 621/1550 (40.1) [P=0.013] 563/1555 (36.2) mFAS: patients, N 250 251 275 275 272 276 280 mFAS: High-quality segments, n (%) [P vs comparator] 218/1250 (17.4) [P<0.001] 134/1255 (10.7) 653/1375 (47.5) [P<0.001] 662/1375 (48.1) [P<0.001] 411/1360 (30.2) 621/1380 (45.0) [P=0.005] 563/1400 (40.2) Per-Protocol: Patients, N 172 207 220 218 232 233 239 Per-Protocol: High-quality segments, n (%) [P vs comparator] 158/860 (18.4) [P<0.001] 111/1035 (10.7) 536/1100 (48.7) [P<0.001] 552/1090 (50.6) [P<0.001] 377/1160 (32.5) 568/1165 (48.8) [P=0.011] 526/1195 (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 ≥75% 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® 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® 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.” Previously published data from two independent, validated, cleansing scales*,** show there is a strong correlation between high quality cleansing scores and increased polyp detection rate (PDR) and adenoma detection rate (ADR). [v],[vi] ADR is one of the primary quality measures of colonoscopy and an indicator of the likelihood of subsequent patient colorectal cancer. Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with over 447,000 new diagnoses every year.[vii] Colorectal cancer is largely preventable, with early detection being associated with a 90% cure rate.[viii] PLENVU® 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. *Boston Bowel Preparation Scale (BBPS) is a 10-point scale assessing bowel preparation after all cleansing manoeuvres are completed by the endoscopist. [ix] **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.[x] GL/PLV/1018/0104 Notes to Editors: 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 product 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. 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. PLENVU is a trademark of the Norgine group of companies. Media Contacts: Isabelle Jouin, T: +44 (0)1895 826237 Follow us @norgine [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 [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] 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. OP251. Endosc. 2018;50(Suppl 1): S87-S88 [vi] 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. OP 252. Endosc. 2018;50 (Suppl 1):S88 [vii] Epidemiology of colorectal cancer in Europe. Source: GLOBOCAN 2012 [viii] American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html. Accessed 10 April 2018 [ix] 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 [x] 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. 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