Norgine announces US FDA approval for PLENVU^® (NER1006) – 1 LITRE PEG based bowel cleansing preparation for colonoscopy

CORPORATE MEDIA RELEASE

NORGINE ANNOUNCES US FDA APPROVAL FOR PLENVU^® (NER1006) – 1 LITRE PEG BASED BOWEL CLEANSING PREPARATION FOR COLONOSCOPY 

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

AMSTERDAM. The Netherlands. Monday 7 May 2018, 12:00 PM BST / 13:00 CET. 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.

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.

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

GL/PLV/0418/0062

Notes to Editors:

PLENVU^® Phase III clinical trial programme

• MORA study. A European study that compared PLENVU^® to MOVIPREP^® using a 2-day evening / morning split-dosing regimen and a 1-Day morning only split-dosing regimen in adults. The study met both of its primary endpoints. When administered using either dosing regimen, PLENVU^® was as effective as MOVIPREP^® in achieving overall bowel cleansing success, and superior to MOVIPREP^® in achieving ‘high quality’ cleansing of the right colon using the Harefield Cleansing Scale (HCS).^[1]
• DAYB study. A European study that compared PLENVU^® to a sodium picosulfate and magnesium salt solution using a 1-Day day before split-dosing regimen in adults. The study met both primary endpoints. PLENVU^® was as effective as sodium picosulfate and magnesium salt solution at achieving overall bowel cleansing success and ‘high quality’ cleansing of the right colon.^[2]
• NOCT study. A US study that compared PLENVU^® to a trisulfate bowel cleansing solution using a 2-day evening / morning split-dosing regimen in adults. Both primary endpoints were met. PLENVU^® was as effective as a trisulfate solution in achieving overall bowel cleansing success and ‘high quality’ cleansing of the right colon.^[3]

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.

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.it

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:

Peter Martin, COO : +441895453744

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[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