Norgine Announces US FDA Approval for PLENVU® (NER1006) - 1 Litre PEG Based Bowel Cleansing Preparation for Colonoscopy

News provided by

07 May, 2018, 11:00 GMT

AMSTERDAM, May 7, 2018 /PRNewswire/ --

US launch date: second half of 2018
In Europe, PLENVU^® is available through Norgine

Norgine B.V. today announced that the US Food and Drug Administration (FDA) has approved PLENVU^® (NER1006), an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. PLENVU^® is the only low volume (1L) polyethylene glycol based (PEG) bowel preparation.

(Logo: http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg )

In the US, PLENVU^® will be made available to patients and healthcare professionals in the second half of 2018 through our partner Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX).

PLENVU^® approvals were based on three phase III clinical trials: NOCT, MORA and DAYB^[1]^,^[2]^,^[3].

Dr Alastair Benbow, Chief Development & Medical Officer at Norgine said: "Colonoscopy is a vital screening procedure to detect and remove adenomas and polyps that could otherwise lead to colorectal cancer. Today's US FDA approval of PLENVU^®, the only 1 litre PEG-based bowel preparation available for colonoscopies is an exciting milestone for our patients and our company. PLENVU^® provides a new effective option for patients who may find it easier to comply with a low volume bowel preparation and, this can help achieve better quality colonoscopy procedure facilitating easier (improved) lesion detection."

Norgine manufactures PLENVU^® globally and commercialises the product through its infrastructure in Europe, Australia and New Zealand.

1. Bisschops R, et al. Tu2084 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. Gastroenterology, Volume 150, Issue 4, Supplement 1, April 2016, Pages s1269-s1270.

2. 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

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. Gastrointest Endosc 2017; 87(3):677-687

For further information on PLENVU^® in the US go to http://www.plenvu.com

GL/PLV/0418/0062

Media Contact:

Peter Martin, COO : +441895453744