NEW PLENVU^® (NER1006) DATA AT ACG SHOWING SUPERIOR BOWEL CLEANSING TO COMMONLY USED PREPARATIONS

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NEW PLENVU^® (NER1006) DATA AT ACG SHOWING SUPERIOR BOWEL CLEANSING TO COMMONLY USED PREPARATIONS

Amsterdam, The Netherlands, Monday 16 October 2017, 16:30 pm CET. Norgine B.V. today presented new data demonstrating the superior high-quality bowel cleansing efficacy (in at least one segment of the colon) of PLENVU^® (NER1006) compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEET^®) and 2-litre PEG with ascorbate (MOVIPREP^®)¹. The data were presented at the World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA. PLENVU^® is a novel 1-litre polyethylene glycol (PEG)-based bowel preparation^2,3,4 currently under regulatory review in the US and EU.

The post-hoc analysis of three phase III clinical trials – DAYB, MORA and NOCT – evaluated high-quality cleansing results (one segment with Boston Bowel Preparation Scale score 3 and all other segments scores >2). The results showed that PLENVU^® produced significantly higher rates of high quality cleansing:

• in the DAYB study compared to a sodium picosulfate and magnesium salt solution, using day-before dosing (11.6% vs. 2.9%; p<0.01).¹
• in the MORA study compared to 2-litre PEG with ascorbate using split dosing (PM/AM, 37.3%; AM/AM, 38.1% vs. 24.6%, both p<0.01).¹

PLENVU^® achieved similar high-quality cleansing results as a trisulfate solution in the NOCT study (32.6% vs. 35.1%, p=0.63).[1] Assessment of adequate cleansing (BBPS segmental score >2) in the overall colon and the right colon showed that PLENVU^® produced numerically higher results compared to all three alternative preparations.

A separate post-hoc analysis of the DAYB, MORA and NOCT trials ⁵ found a positive relationship between cleansing grade and improved lesion detection rates, suggesting that high-quality bowel cleansing may improve polyp and adenoma detection rates in the overall colon.

Dr Cesare Hassan of the Nuovo Regina Margherita Hospital, Rome, Italy said, “These results confirm that PLENVU^® achieves consistent excellent bowel cleansing, with lower volume intake, compared to widely used alternative preparations. Combined with the finding that better cleansing may improve polyp and adenoma detection, PLENVU^® has the potential to improve outcomes and save healthcare resources.”

He added, “The very high quality of the PLENVU^® studies emphasise that these results are robust and irreversible.”

In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals to commericalise PLENVU^® in the US and Canada.

PLENVU^® is not yet approved for use in the US or Europe. Norgine anticipates regulatory approval in Europe in 2017 and in 2018 in the US.

Ends

GL/PLV/1017/0039

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.^2,3,4 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.⁶

The PLENVU^® Phase III clinical trial programme consists of three multicentre, randomised, parallel group studies:

• MORA study. A European study that compared NER1006 versus a 2L PEG with ascorbate bowel cleansing solution 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 as either dosing regimen, NER1006 was as effective in achieving overall bowel cleansing, and superior in achieving ‘Excellent plus Good’ cleansing of the colon ascendens compared to 2L PEG plus ascorbate. NER1006 demonstrated an acceptable safety profile.³
• 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 trisulfate in achieving overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS). NER1006 demonstrated an acceptable safety profile.⁴
• DAYB study. A European study that compared NER1006 versus a sodium picosulfate and magnesium salt solution using a day before only 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 successful bowel cleansing and ‘Excellent plus Good’ cleansing in the colon ascendens.²

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.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 Contacts:

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

Charlotte Andrews, T: +44 (0)1895 453607

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References

¹ 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. Hassan C, Manning J, Amlani B, Epstein M. P1041. Presented at World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017.
² 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
³ 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
⁴ DeMicco M, et al. OP375. Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study NOCT. UEG Journal 2016; 4(5S): A415-A416
⁵ High Quality Colon Cleansing Improves Polyp and Adenoma Detection Rates: Post hoc Analysis of 1,749 Patients in 3 Randomized Phase 3 Clinical Trials. Hassan C, Manning J, Amlani B, Epstein M. P1040. Presented at World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017.
⁶ Lasisi F, et al. Expert Rev Gastroenterol Hepatol 2011; 5(6): 745-754.