NORGINE PRESENTS NEW PLENVU® (NER1006) DATA AT THE WORLD CONGRESS OF GASTROENTEROLOGY ACG 2017

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16 October 2017

CORPORATE PRESS RELEASE


NORGINE PRESENTS NEW PLENVU® (NER1006) DATA AT THE WORLD CONGRESS OF GASTROENTEROLOGY ACG 2017

– Two posters win 2017 Presidential Poster Award

 

Amsterdam, The Netherlands, Monday 16 October 2017, 14.00 pm CET. Norgine B.V. today announced it is presenting six posters at the World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017. Key data will be highlighting the efficacy of PLENVU® (NER1006), a novel 1-litre polyethylene glycol (PEG)-based bowel preparation currently under regulatory review in the US and in the EU.

Two posters won the 2017 Presidential Poster Award:

  • P1040. 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. Monday 16 October 2017, 10:30 am-16:00 pm ET.1
  • P2036. Achieving Successful Bowel Preparation (BBPS Score 2-3 per Segment) With Evening/Morning or Morning-Only Split-Dosing Regimens of NER1006 versus 2L Polyethylene Glycol With Ascorbate: Post hoc Analysis of a Phase 3 Trial. Amlani B, Bisschops R. P2036. Tuesday 17 October 2017, 10:30 am-16:30 pm ET.2

The other posters being presented at the congress are:

  • 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. Monday 16 October 2017, 10:30 am-16:00 pm ET.3
  • Bowel Preparation Quality of NER1006 versus Oral Trisulfate Solution as Assessed by Colonoscopists at Site: A Post hoc Analysis From a Randomized Controlled Trial. Epstein M, Ng Kwet Shing R, Amlani B.  P1789. Tuesday 17 October 2017, 10:30 am-16:30 pm ET.4
  • Novel 1L Polyethylene Glycol (PEG)-Based Bowel Preparation NER1006 Achieves Higher Quality Bowel Cleansing With Low Mandated Total Fluid Volume Intake: A Post hoc Analysis versus Standard 2L PEG + Ascorbate. P1790. Epstein M,  Clayton L, Ng Kwet Shing R. Tuesday 17 October 2017, 10:30 am-16:30 pm ET.5
  • Achieving Successful Bowel Preparation (BBPS Score 2-3 per Segment) With Evening/Morning Split-Dosing Regimens of NER1006 versus Trisulfate: Post hoc Analysis of a Phase 3 Trial. Epstein M, Amlani B, Bekal P. P2033. Tuesday 17 October 2017, 10:30 am-16:30 pm ET.6

PLENVU® is a novel, low-volume (1-litre) PEG-based bowel preparation for cleansing of the colon in preparation of colonoscopy.7,8,9 

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.

The PLENVU® Phase III clinical trial programme includes three multicentre randomised parallel group studies: NOCT, MORA, and DAYB .7,8,9  In August 2016, Norgine entered into a licensing agreement with Valeant Pharmaceuticals for the commericalisation of PLENVU® in the US and Canada.

PLENVU® is not yet approved for use in the US. Norgine anticipates regulatory approval in 2018 in the US. PLENVU®’s licence in the UK, is expected in Q4 2017. Further EU approvals are expected throughout 2018.

Ends

Notes to Editors:

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 Contact:

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

Follow us @norgine

 

References
1 Hassan C et al. High Quality Colon Cleansing Improves Polyp and Adenoma Detection Rates: Post hoc Analysis of 1,749 Patients in 3 Randomized Phase 3 Clinical Trials. American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

2 Amlani B et al. Achieving Successful Bowel Preparation (BBPS Score 2-3 per Segment) With Evening/Morning or Morning-Only Split-Dosing Regimens of NER1006 versus 2L Polyethylene Glycol With Ascorbate: Post hoc Analysis of a Phase 3 Trial. American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

3 Hassan C et al. 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. American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

4 Epstein M et al. Bowel Preparation Quality of NER1006 versus Oral Trisulfate Solution as Assessed by Colonoscopists at Site: A Post hoc Analysis From a Randomized Controlled Trial. American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

5 Epstein M et al. Novel 1L Polyethylene Glycol (PEG)-Based Bowel Preparation NER1006 Achieves Higher Quality Bowel Cleansing With Low Mandated Total Fluid Volume Intake: A Post hoc Analysis versus Standard 2L PEG + Ascorbate. American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

6 Epstein M et al. Achieving Successful Bowel Preparation (BBPS Score 2-3 per Segment) With Evening/Morning Split-Dosing Regimens of NER1006 versus Trisulfate: Post hoc Analysis of a Phase 3 Trial. American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

7 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

8 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

9 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