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

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24 October 2017

CORPORATE MEDIA RELEASE

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

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

Amsterdam, The Netherlands, Tuesday 24 October, 09:45 BST, 10:45 CET.  Norgine B.V. today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PLENVU® (NER1006) for bowel cleansing in adults prior to any procedure requiring a clean bowel. The approval was granted under the European Medicines Agency decentralised procedure, with the UK as reference state.

PLENVU® has also been approved by the Lyfjastofnun, Icelandic Medicines Agency.

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, shown to be superior in providing high-quality cleansing in the colon ascendens, an important area for adenoma detection.[2]

Dr Alastair Benbow, Chief Development & Medical Officer, Norgine, said, “We look forward to making PLENVU® available to physicians and patients, to improve the quality of colonoscopy. PLENVU® has the potential to become the gold standard and replace other bowel preparations, and is part of our ongoing commitment to bring innovative products to market in gastroenterology, one of our core areas of expertise.”

The approval was 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 as either dosing regimen, NER1006 was as effective in achieving overall bowel cleansing, and as effective and superior in achieving ‘Excellent plus Good’ cleansing of the colon ascendens compared to 2-litre PEG. Overall tolerability was comparable to MOVIPREP®.[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 a trisulfate solution in achieving overall bowel cleansing success and ‘Excellent plus Good’ cleansing of the colon ascendens using the Harefield Cleansing Scale (HCS). NER1006 was well tolerated.[3]
  • 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 successful bowel cleansing and ‘Excellent plus Good’ cleansing in the colon ascendens. NER1006 was well tolerated.[4]

Colonoscopy is a vital screening procedure to detect colorectal cancer, the second most common cause of cancer-related mortality in Europe, with 412,000 new diagnoses every year.[5] In the UK there were more than 41,000 new cases of colorectal cancer in 2014, and more than 15,000 deaths, making it the second most common cause of cancer death.[6]

Norgine manufactures PLENVU® globally and will commercialise the product through its infrastructure in Europe and Australia and through its commercial partners in the rest of the world.

 

Notes to Editors:

About PLENVU®

PLENVU® (NER1006) is a novel, low-volume (1 litre) polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. PLENVU® offers flexible dosing and different flavours in each 500mL dose to support an enhanced patient experience.[1] PLENVU® achieved high successful overall bowel cleansing efficacy in phase III studies versus standard 2-litre PEG preparations with ascorbate, sodium picosulfate with magnesium salt, and a trisulfate solution.[1,3,4]

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.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

 

GL/COR/1017/0125

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

 [3] 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].

[4] 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

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

[6] http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer (Accessed September 2017)