Positive new data show superiority of PLENVU^® (1 LITRE PEG preparation) compared to MOVIPREP^® (2 LITRE PEG + ASCORBATE)

CORPORATE MEDIA RELEASE

POSITIVE NEW DATA SHOW SUPERIORITY OF PLENVU^®

(1 LITRE PEG PREPARATION) COMPARED TO MOVIPREP^®

(2 LITRE PEG + ASCORBATE)^[1]

• PLENVU^® is the first 1 Litre PEG preparation bowel preparation^[2],[3],[4] to demonstrate higher cleansing efficacy than MOVIPREP^® (2 Litre PEG + Ascorbate)

AMSTERDAM. The Netherlands, 22 February 2018, 16:30 CET. Norgine B.V. today announced positive new PLENVU^® (NER1006) superiority data at the meeting of the Belgian Society for Gastrointestinal Endoscopy (BSGIE). This post hoc analysis of the MORA phase III study, assessed PLENVU^® cleansing efficacy versus MOVIPREP^® in both the overall colon and the right colon, using mean Boston Bowel Preparation Scale (BBPS) Scores.

The analysis included 792 patients . Both PLENVU^® PM/AM and PLENVU^® AM/AM attained higher mean overall BBPS scores than MOVIPREP^® PM/AM (6.7 and 6.6 versus 6.3; P=0.0001 and P=0.0058 respectively). Similarly in the right colon, both PLENVU^®  PM/AM and PLENVU^®  AM/AM attained significantly higher mean segmental BBPS scores versus MOVIPREP^® PM/AM (2.2 and 2.2 versus 2.0; P=0.0003 and P=0.0134).

Prof. Raf Bisschops said: “These new data are important. By demonstrating higher cleansing efficacy of the colon compared to the standard 2 litre PEG + Ascorbate bowel preparation, it is clear that PLENVU^® can help achieve better quality colonoscopy procedure in order to facilitate lesion detection. PLENVU^® provides a new effective option for healthcare professionals and for patients who may find it easier to comply with a low volume bowel preparation.”

Dr Alastair Benbow, Chief Development & Medical Officer at Norgine said: “We believe that PLENVU^® should be offered as the standard bowel cleansing option for all patients undergoing a colonoscopy. Not only do patients want a low-volume preparation which is easy to use, but they want to use a bowel cleanser which is effective to detect adenomas and polyps that can result in colorectal cancer.”

Colonoscopy is a vital screening procedure to detect lesions. Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with over 447,000 new diagnoses every year.[5]

The post hoc data analysis of the MORA study was sponsored by Norgine.

Presentation: Prof. Raf Bisschops on Thursday 22 February 2018, 16:00 – 16:30 at the Belgian Society for Gastrointestinal Endoscopy (BSGIE).¹

PLENVU^® is now approved for use in Australia, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Norway, Portugal, Romania, The Netherlands and in the UK (using the trademark PLEINVUE^™ in Austria and The Netherlands). PLENVU^® is already commercially available via Norgine’s infrastructure in the UK and Belgium.

 Notes to Editors:

PLENVU^® phase III clinical trial programme

The PLENVU^® European approvals were based on data from the phase III clinical trial programme, consisting of three multicentre, randomised, parallel group studies:

• MORA study. A European study that compared PLENVU^® versus MOVIPREP^® using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. The study met both 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 colon ascendens using the Harefield Cleansing Scale (HCS).²
• NOCT study. A US study that compared PLENVU^® versus a trisulfate bowel cleansing solution using a 2-day 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 achieving high quality cleansing of the colon ascendens.³
• DAYB study. A European study that compared PLENVU^® versus a sodium picosulfate and magnesium salt solution using a 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 colon ascendens.⁴

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 was 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.

PLENVU and PLEINVUE are trademarks of the Norgine group of companies.

Media Contacts:

Isabelle Jouin, T: +44 (0)1895 453643

Follow us @norgine

GL/PLV/0218/0051

[1] Bisschops R et al. Higher Mean Boston Bowel preparation scale scores with 1l NER1006 versus 2l PEG + ascorbate: post hoc analysis of a randomised phase 3 clinical trial. Thursday 22 February 2018, 16:00 – 16:30 Belgian Society for Gastrointestinal Endoscopy (BSGIE). “Acta Gastroenterologica Belgica” issue 1, 2018.

[2] 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.

[3] 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

[4] 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

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