CORPORATE MEDIA RELEASE
NORGINE ANNOUNCES FDA FILING ACCEPTANCE FOR PLENVU® (NER1006)
-Launch date set for first quarter 2018
Amsterdam, The Netherlands. Wednesday 28 June 2017. 22:00 CET. Norgine B.V. today announced that it has received acceptance from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for PLENVU®* (NER1006). PLENVU® is a novel, low-volume (1L) polyethylene glycol based bowel preparation that has been developed to provide complete bowel cleansing, with an additional focus on the ascending colon.
In August 2016, Norgine out-licensed PLENVU® to Salix in the US and Canada.
Peter Stein, Chief Executive Officer, Norgine, said “We are pleased to receive filing acceptance from the FDA for PLENVU® and we are looking forward to continuing our collaboration with Salix. This partnership will ensure that patients have access to a new and proven low volume bowel preparation, that can improve the quality of colonoscopy. In turn this will ultimately enhance the detection of adenomas and polyps that frequently go undetected and often result in colorectal cancer.”
“Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps”, said Mark McKenna, senior vice president and general manager, Salix Pharmaceuticals. “If approved, PLENVU® may enhance bowel cleansing and the overall bowel prep experience relating to a colonoscopy.”
Norgine will manufacture PLENVU® globally and commercialise the product through its infrastructure in Europe, Australia and New Zealand.
*Provisionally approved name
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.
The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from companies that produce certain human drug and biological products, including when an NDA is submitted. It is usual for the FDA to set a PDUFA goal date when responding to an NDA.
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.
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.
Salix Pharmaceuticals, Ltd., a Valeant Pharmaceuticals International, Inc. company is one of the largest gastrointestinal specialty pharmaceuticals companies in the world. Salix develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases and disorders. For more information on Salix Pharmaceuticals, visit www.salix.com
Norgine Media Contacts:
Isabelle Jouin, T: +44 (0)1895 453643
Charlotte Andrews, T: +44 (0)1895 453607
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 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
 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
 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