Norgine and its partner Salix announce the US launch of PLENVU^®

NORGINE AND ITS PARTNER SALIX ANNOUNCE THE US LAUNCH OF PLENVU^®

• In the US PLENVU^® is now available for prescription and offers same-day morning-of-colonoscopy and 2-day split-dosing regimens

• In Europe, PLENVU^®is available through Norgine

AMSTERDAM, The Netherlands, 11September, 13:00 CET.  Norgine and its partner Salix Pharmaceuticals, 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 Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced the US launch and availability of PLENVU^® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), a lower-volume (1L) polyethylene glycol based (PEG) bowel preparation for colonoscopy.

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

Colonoscopy is an effective method for colorectal cancer screening and has been shown to reduce both the incidence and mortality of colorectal cancer when applied in the general population. Inadequate precolonoscopy bowel cleansing reduces the diagnostic accuracy of colonoscopy, particularly for the detection of smaller lesions and sessile polyps. This may result in repeat procedures, thereby increasing costs and potentially delaying the initiation of treatment, and potentially increasing resource requirement.^[4],[5],[6]

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

For further information on PLENVU^® in the EU go to https://www.expertiseincolonoscopy.com/plenvu

GL/PLV/0818/0094

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.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: ijouin@norgine.com

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 References

[1] Bisschops R, et al. Colon cleansing efficacy and safety with 1L NER1006 versus 2L polyethylene glycol + ascorbate: a randomized Phase 3 trial. ENDOSCOPY. https://doi.org/10.1055/a-0638-8125

[2] Schreiber, et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy 2019; 51: 1–16 https://doi.org/10.1055/a-0639-5070

 [3] DeMicco MP, et al.  Gastrointest Endosc. 2018: 87(3):677-687

[4] Bechtold ML, Mir F, Puli SR et al. Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization. Ann Gastroenterol 2016; 29: 137 – 146

[5] Brenner H, Stock C, Hoffmeister M. Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. BMJ 2014; 348: g2467

[6] Baxter NN, Warren JL, Barrett MJ et al. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol 2012; 30: 2664 – 2669