NEW POSITIVE EU PHASE III DATA SHOW EFFICACY OF PLENVU^™ (NER1006), A LOW VOLUME, PEG BASED BOWEL CLEANSING SOLUTION

-Non-inferiority in overall bowel cleansing success
-Achieved an ‘Excellent plus Good’ cleansing rate in the ascending colon

London, UK. Wednesday 19 October 2016, 08:00 BST. Norgine B.V. today announced that the European DAYB study that compares PLENVU^™ (NER1006) to a magnesium salt solution (CITRAFLEET^®) using a day before only dosing regimen met both primary endpoints and all secondary endpoints. In the study, PLENVU^™ demonstrated non-inferiority in overall bowel cleansing success and achieved an ‘Excellent plus Good’ cleansing rate in the ascending colon. These data were presented at United European Gastroenterology Week (UEGW) 2016.

The study met all of its secondary endpoints demonstrating non-inferior adenoma and polyp detection rates in both the overall colon and ascending colon. ¹

PLENVU^™ has been developed to provide overall bowel cleansing in adults, with an additional focus on the ascending colon. 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. ²

PLENVU^™ demonstrated an acceptable safety profile in day-before split-dosing administration.

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, with 412,000 new diagnoses of colorectal cancer diagnosed every year. ³

Dr Alastair Benbow, Chief Development & Medical Officer, Norgine said, “These data are important because they demonstrate that PLENVU^™ is an effective bowel cleanser and enables better detection of adenomas and polyps. PLENVU^™ offers patients a new colorectal screening alternative that could improve their health outcomes and ultimately reduce the cost of healthcare systems.”
PLENVU^™ is not yet approved for use.

Other data presented at UEGW included:

• Efficacy and safety of the novel 1L PEG and ascorbate bowel prearation PLENVU^™ versus standard 2L PEG with ascorbate in overnight or morning split-dosing administration: Results from the phase III study MORA. P0179, 17 October 2016 from 10:30 - 17:00.
• Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation PLENVU^™ versus trisulfate solution in overnight split-dosing administration: Results from the phase 3 study NOCT. OP375, 19 October 2016, 10:30 - 12:00.

Ends

GL/COR/1016/0082
October 2016

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.

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 III study DAYB

This phase 3, randomised, multicentre, colonoscopist-blinded, non-inferiority study assessed the efficacy, safety and tolerability of a day before split-dosing regimen of either NER1006 (evening time) or sodium picosulfate + magnesium citrate (SPM: regimen per label) in patients undergoing colonoscopy. Two alternative primary endpoints were evaluated: overall bowel cleansing success and ‘Excellent plus Good’ cleansing rate in the ascending colon including the caecum using the Harefield Cleansing Scale (HCS). Secondary endpoints included hierarchical evaluation of adenoma/polyp detection rates, and cleansing assessment using the Boston Bowel Preparation Scale (BBPS). Patient tolerability, acceptability and compliance were assessed using a questionnaire. Safety was monitored through adverse events reporting and clinical laboratory evaluation. The threshold for statistical significance in this study was P<0.025. The confidence interval for the difference between the groups used a 10% margin to demonstrate non-inferiority vs. SPM.

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.
• 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.
  
• 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.

About Norgine

Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people.

Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients.  Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.

Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in 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.

Norgine Media Contacts
Isabelle Jouin, T: +44 (0)1895 453643
Charlotte Andrews, T: +44 (0)1895 453607
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¹ 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. Abstract 1243. UEGW 2016

² Brenner H et al. Protection From Right- and Left-Sided Colorectal Neoplasms After Colonoscopy: Population-Based Study. J Natl Cancer Inst 2010;102:89-95

³ Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915