NORGINE PRESENTS NEW POST-HOC DATA ANALYSES HIGHLIGHTING THE EFFICACY OF PLENVU^® FOR BOWEL CLEANSING AT DDW

CORPORATE MEDIA RELEASE

NORGINE PRESENTS NEW POST-HOC DATA ANALYSES HIGHLIGHTING THE EFFICACY OF PLENVU^® FOR BOWEL CLEANSING AT DDW

London, UK. Saturday 6 May 2017. 18:00 BST. Norgine B.V. today presented new post-hoc analyses from the phase III DAYB and MORA studies that demonstrate the high-quality cleansing efficacy of PLENVU^®, a low volume, 1 litre PEG and ascorbate bowel preparation when compared to sodium picosulfate with magnesium citrate (CITRAFLEET^®) and 2 litre PEG with ascorbate (MOVIPREP^®) respectively when using site colonoscopist assessments.^[1],[2] In addition, data from the DAYB study show that PLENVU^® achieved statistically significant improvements in adequate cleansing rates using the Boston Bowel Preparation Score when compared to sodium picosulfate with magnesium citrate.^[3]

High cleansing efficacy:

• In the DAYB study, when compared to sodium picosulfate with magnesium citrate (CITRAFLEET^®) using a day before dosing, PLENVU^® achieved significantly better cleansing success
  • in the overall colon (73.3% vs 60.9%, P=0.003)¹
  • and a high-quality cleansing of the ascending colon (36.3% vs 15.4%, P<0.001)¹
• In the MORA study, when compared to standard 2 litre PEG with ascorbate (MOVIPREP^®), PLENVU^® achieved a significantly improved rate of;
  • cleansing in the overall colon when administered as an evening/morning split-dose (97.0% vs 90.9%, P=0.003)²
  • high-quality cleansing in the ascending colon when administered as an overnight split-dose (74.8% vs 60.9%, P<0.001) or morning-only dose (75.8% vs 60.9%, P<0.001)²

Improved cleansing (Boston Bowel Preparation Scale) in evening only dosing when compared to sodium picosulfate with magnesium citrate;

• PLENVU^® achieved a statistically significantly increased proportion of adequate level cleansing of the overall (61.9% vs 47.3%, P=0.001) and ascending colon (66.9% vs 50.2%, P<0.001) in patients with Boston Bowel Preparation Scale scores³

PLENVU^® has been shown to be well tolerated in studies versus standard 2 litre PEG with ascorbate, sodium picosulfate with magnesium citrate and trisulfate solution.^[4],[5],[6]

Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented “These phase III data confirm the potential of PLENVU^®, a low volume bowel preparation to replace standard bowel preparations. As colonoscopy is considered one of the most effective colorectal screening procedures, use of a highly efficacious bowel preparation such as PLENVU^® is important to enable better detection of adenomas and polyps which ultimately will improve patients outcomes and save healthcare systems resources.”

These data were presented at Digestive Diseases Week, 6-9 May 2017, Chicago.

The PLENVU^® Phase III clinical trial programme includes three multicentre, randomised, parallel group studies: NOCT, MORA, and DAYB.

Colorectal cancer is the second most common cause of cancer-related mortality in Europe and the US, with 412,000 new diagnoses of colorectal cancer every year in Europe and 136,115 in the US.^[7],[8]

PLENVU^® data being presented at DDW on Saturday 6 May, 12:00 CDT

• Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. Poster Sa1096
• Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post-hoc analysis from a randomized controlled trial. Poster Sa1109
• Achieving adequate level bowel preparation with evening only dosing of novel NER1006 versus sodium picosulfate + magnesium citrate: post-hoc analysis from a randomized controlled trial. Poster Sa1120
• High cleansing efficacy of NER1006 also in the elderly; subgroup analysis of randomized phase 3 trials. Poster Sa1110

In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for 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/COR/0417/0105
May 2017

Notes to Editors:

About PLENVU^® (NER1006

PLENVU^® (NER1006) is a novel, low volume (1L) polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. This low-volume solution is developed not only to support improved patient acceptability and compliance but also to contribute to effectiveness of colonoscopy procedures at detecting colon cancer and for optimised bowel surveillance, through effective bowel cleansing.

About the phase III clinical trial programme

• NOCT study. A U.S. study that compares PLENVU^® versus a trisulfate bowel cleansing solution (SUPREP^®) using a 2-day split-dosing regimen in adults. Both primary endpoints were met, achieving non-inferior overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS). PLENVU^® demonstrated an acceptable safety profile.⁵
• MORA study. A European study that compares PLENVU^® versus a 2L PEG (MOVIPREP^®) 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 showing that when administered as either a 2-day overnight or 1-day morning split-dosing regimen, and compared to 2L PEG, PLENVU^® was non-inferior in achieving overall bowel cleansing, and non-inferior and superior in achieving ‘Excellent plus Good’ cleansing of the colon ascendens. PLENVU^® demonstrated an acceptable safety profile.⁴
• DAYB study. A European study that compares PLENVU^® versus a sodium picosulfate and magnesium salt solution (CITRAFLEET^®) using a day before only split-dosing regimen in adults. Although the study met both primary endpoints, demonstrating non inferiority, the data will contribute to safety evaluation only. The study used a dosing schedule for the comparator that is not relevant to current medical practice in U.S. PLENVU^® demonstrated an acceptable safety profile.⁶

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] Lewis S. et al. Bowel preparation quality of NER1006 versus sodium picosulfate + magnesium citrate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1109. Digestive Diseases Week, 6-9 May 2017

[2] Manning, J. et al. Bowel preparation quality of NER1006 versus standard 2L PEG with ascorbate as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial. Sa1096. Digestive Diseases Week, 6-9 May 2017

[3] Hassan, C. et al. Achieving adequate level bowel preparation with day before dosing regimens of NER1006 versus sodium picosulfate + magnesium citrate: post hoc analysis of a Phase 3 trial. Sa1120. Digestive Diseases Week, 6-9 May 2017

[4] Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration: results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218 – A219

[5] 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(Suppl1): A415-A416

[6] Schreiber, et al. P1266 Efficacy and safety of the novel 1 L 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(Suppl1): A589-A590

[7] Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915

[8] Colorectal Cancer Statistics 2013. Centers for Disease and Control and Prevention. https://www.cdc.gov/cancer/colorectal/statistics/ [Accessed 25 April 2017]