NORGINE LAUNCHES PLENVU^® (NER1006) IN THE UNITED KINGDOM

CORPORATE MEDIA RELEASE

NORGINE LAUNCHES PLENVU^® (NER1006) IN THE UNITED KINGDOM

• First 1 litre PEG-based bowel preparation^[1],[2],[3]
• Superior high-quality bowel cleansing efficacy to MOVIPREP^® and CITRAFLEET^®[4]

Amsterdam, The Netherlands, Tuesday 31 October 2017, 08:00 CET.  Norgine B.V. today announced the availability of PLENVU^® in the United Kingdom. PLENVU^® is a novel 1-litre polyethylene glycol (PEG)-based bowel preparation for cleansing of the colon prior to any procedure requiring a clean bowel.^[5]

Norgine developed PLENVU^® to provide whole bowel cleansing. PLENVU^® provides superior high-quality bowel cleansing efficacy (in at least one segment of the colon)  compared to two widely used alternative bowel preparations: sodium picosulfate and magnesium salt solution (CITRAFLEET^®) and 2-litre PEG with ascorbate (MOVIPREP^®).⁴

PLENVU^® demonstrated an acceptable safety profile in NOCT, MORA, and DAYB phase III studies.^1.2.3

Jonathan Manning, Consultant Gastroenterologist, said: “It is important to have highly effective bowel cleansing for conducting a good colonoscopy, especially in the ascending colon, where adenomas and polyps are often more difficult to see. In addition patients want a low-volume preparation that is easy to use. PLENVU^® provides all these benefits.”

Interim Chief Executive of Beating Bowel Cancer Judith Brodie said: “Colorectal cancer screening can save lives, so it is valuable to seek and provide innovative new products which may improve the patient experience, and their participation in screening. We welcome these developments as early diagnosis of bowel cancer in patients is crucial.”

Andy Crichton, General Manager UK and Ireland, Norgine, said: “We are delighted to offer a new option to patients to improve the quality of cleansing of the bowel. Having a bowel cleanser with a lower volume that cleans the bowel better to improve visibility during a colonoscopy is a major step forward to improve the detection of any anomalies. This means that polyps and small tumours can then be detected and removed to avoid developing life-threatening or terminal conditions such as bowel cancer.”

Colonoscopy is a vital screening procedure to detect lesions. Colorectal cancer is the second most common cause of cancer-related mortality in Europe, with 447,000[6] new diagnoses every year.^[[7]] 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.^[[8]]

Norgine manufactures PLENVU^® and commercialises the product through its infrastructure in Europe and Australia. Norgine commercialises the product through its commercial partners in the rest of the world.

Ends

Notes to Editors:

About PLENVU^®

PLENVU^® (NER1006) is a novel, low-volume (1-litre) PEG-based bowel preparation for cleansing of the colon in preparation of colonoscopy.^1,2,3 Effective bowel preparation is an important factor for a successful colonoscopy and for detecting adenomas and polyps. Visualisation of the ascending colon is important because adenomas and polyps in this area are often more difficult to see than those in other areas of the colon.[9]

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

PLENVU, 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/PLV/1017/0043

[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] DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. 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 Aug 10. pii: S0016-5107(17)32172-7. doi:10.1016/j.gie.2017.07.047.

[3] 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

[4] Hassan C, Manning J, Amlani B, Epstein M. High Quality Colon Cleansing With Novel 1L PEG-Based Bowel Preparation NER1006 versus Current Alternatives: Post hoc Analysis of 1,521 Patients in 3 Randomized Phase 3 Trials. P1041. Presented at World Congress of Gastroenterology at the American College of Gastroenterology (ACG) in Orlando, Florida, USA, 13-16 October, 2017

[5] PLENVU^® Summary of Product Characteristics

[6]  Epidemiology of colorectal cancer in Europe. Source: GLOBOCAN 2012

^[[7]^] Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915

^[[8]] http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer (Accessed October 2017)

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