Norgine’s PLENVU^® (NER1006) receives approval in Germany for bowel cleansing in adults prior to any procedure requiring a clean bowel

CORPORATE MEDIA RELEASE

NORGINE’S PLENVU^® (NER1006) RECEIVES APPROVAL IN GERMANY FOR BOWEL CLEANSING IN ADULTS PRIOR TO ANY PROCEDURE REQUIRING A CLEAN BOWEL

• PLENVU^® is the first 1-litre PEG bowel preparation^[1],[2],[3]
• PLENVU^® is superior to MOVIPREP^® in providing high-quality cleansing in the colon ascendens^[1] – an important area for adenoma detection^[4]

Amsterdam, The Netherlands, Thursday 8 February 2018, 13:00 CET. Norgine B.V. today announced that the marketing authorisation for PLENVU^® for bowel cleansing in adults prior to any procedure requiring a clean bowel, has been granted by the German regulatory authority. The approval was granted under the European decentralised procedure, with the UK as reference state. Norgine anticipates launch of PLENVU^® in Germany later this year.

PLENVU^® is now approved for use in Australia, Austria, Belgium, Croatia, Denmark, Finland, France, 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 in the UK and Belgium.

PLENVU^® is a novel, low volume (1-litre) polyethylene glycol (PEG) 3350-based bowel preparation that has been developed by Norgine to provide whole bowel cleansing.

PLENVU^® provides superior high-quality bowel cleansing efficacy (in at least one segment of the colon) compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEET^®) and 2-litre PEG with ascorbate (MOVIPREP^®).^[5]

The 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 NER1006 versus a 2 litre PEG with ascorbate bowel cleansing solution (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, NER1006 was as effective as MOVIPREP^® in achieving overall bowel cleansing success, and superior to MOVIPREP^® in achieving ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS).^[1]
• NOCT study. A US study that compared NER1006 versus a trisulfate bowel cleansing solution using a 2-day split-dosing regimen in adults. Both primary endpoints were met: NER1006 was as effective as a trisulfate solution in achieving overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens.^[2]
• DAYB study. A European study that compared NER1006 versus a sodium picosulfate and magnesium salt solution using a day before split-dosing regimen in adults. The study met both primary endpoints: NER1006 was as effective as sodium picosulfate and magnesium salt solution at achieving overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens.^[3]

PLENVU^® (NER1006) demonstrated an acceptable safety profile in the NOCT, MORA, and DAYB phase III studies.^[1][2][3]

Colonoscopy is a vital screening procedure to detect lesions. Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with 447,000 new diagnoses every year.^[6]

Norgine manufactures PLENVU^® and commercialises the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.

GL/PLV/1117/0047a(1)

Notes to Editors:

About PLENVU^®

PLENVU^® (NER1006) is a novel, low-volume (1-litre) PEG-based bowel preparation for cleansing of the colon in preparation of colonoscopy.^[1][2][3] Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps. Visualisation of the ascending colon is important because adenomas and polyps in this area are often more difficult to see than those in other areas of the colon.^[4]

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total revenue was EUR 368 million. 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.it

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.

PLENVU, PLEINVUE, NORGINE and the sail logo are trademarks of the Norgine group of companies.

Media Contact:

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

Follow us @norgine

References

[1] 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.

[2] 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. Gastroentest Endosc 2017; Aug 10. pii: S0016-5107(17)32172-7. doi: 10.1016/j.gie.2017.07.047. [Epub ahead of print].

[3] 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

[4] Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754.

[5] Hassan C, Manning J, Amlani B, Epstein M. High Quality Colon Cleansing With Novel 1L PEG-Based Bowel Preparation NER1006 versus Current Alternatives: Post hoc Analysis of 1,521 Patients in 3 Randomized Phase 3 Trials. P1041. Presented at World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

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