POSITIVE RESULTS FROM PHASE II DATA SHOW NER1006 ACHIEVES HIGH QUALITY BOWEL CLEANSING EFFICACY

LONDON, UK, Monday 20 October 2014, 13:00 BST – Norgine B.V. today announced that the Phase II study of its novel, low volume bowel preparation, NER1006, presented at the 79^th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA has met its primary efficacy end point of stool weight and co-primary endpoint of cleansing success. The study demonstrated high quality bowel cleansing efficacy with NER1006 vs. MOVIPREP^® in screening colonoscopy patients.[1]

The Phase II open-label, randomised study (OPT, n=240) investigated the pharmacodynamics (stool weight), clinical efficacy and tolerability of dose and taste-optimised low-volume PEG-based formulations (NER1006), after split dosing, compared with MOVIPREP^®.¹ Results demonstrate that NER1006 achieved high quality bowel cleansing in screening colonoscopy patients, comparable with MOVIPREP^®. Cleansing success rates were 90-100%.¹ Stool output was consistently higher with NER1006, and safety and tolerability profiles between treatments were comparable.¹ In addition, most subjects in the NER1006 arms reached clear effluent.¹

“Effective bowel cleansing is vital to delivering a successful colonoscopy procedure. This Phase II study confirms that NER1006, a low volume preparation is preferential for some patients and improves tolerability. We are hoping that the Phase III programme will further show the efficacy and tolerability of NER1006,” commented Donna McVey, Chief Development Officer, Norgine.

Norgine has now enrolled the first patient into the first study of its Phase III programme, NOCT, a US study. The Phase III programme consists of three clinical trials: NOCT is a multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms, MORA and DAYB are European studies to further investigate the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006.

Two additional Norgine abstracts were presented at ACG 2014 supporting the strength of Norgine’s bowel cleansing franchise.

• The Norgine-developed Harefield Cleansing Scale (HCS) was compared to the Boston Bowel Preparation Scale (BBPS) in one abstract, and awarded the ACG Presidential Poster Award 2014.[2]
• Results of a multicentre, randomised, investigator-blinded study (MODEC) to assess polyp and adenoma detection rate of Norgine’s MOVIPREP^® versus Sodium Picosulfate/Magnesium Citrate was the subject of a further abstract at ACG 2014.[3]

Ends

Notes to Editors

* 32 US fluid ounce / approx. 1 litre

** The following primary endpoints will be investigated by the NOCT study:

1. The overall bowel cleansing success rate of NER1006 compared to SUPREP^®, as graded by the Harefield Cleansing Scale (HCS),[4] wherein success corresponds to Grades A and B, and failure corresponds to Grades C and D.
2. The “Excellent plus Good” cleansing rate in the colon ascendens of NER1006 compared to SUPREP^® using the segmental cleansing scoring system of the HCS, wherein the ordinal score of 4 corresponds to “Excellent” and the score of 3 corresponds to “Good” cleansing.

About NER1006

NER1006 is a novel, low volume polyethylene glycol (PEG) 3350-based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. The dosing regimen of NER1006 (32 fl oz*, of bowel preparation solution with 32 fl oz* of extra water or clear fluid) aims to deliver a high level of efficacy. 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.
^[5]

Phase II clinical programme

The open-label, randomised, 2-part (Part A: healthy subjects; Part B: screening colonoscopy subjects), Phase II study investigated the pharmacodynamics (stool weight), tolerability, and clinical efficacy of dose- and taste-optimised low-volume PEG-based formulations (NER1006) after split dosing compared with MOVIPREP^®. The primary endpoint in Parts A and B was 24h stool weight (desired target ≥2750g). Cleansing success rate (Harefield Cleansing Scale) was a co-primary endpoint in Part B. Secondary endpoints included time and volume of study drug to reach clear effluent, safety and tolerability (including vomiting rate). 120 subjects were included in each part (n=30/arm). For subjects who completed dosing, vomiting rates were <7.0& and <3.5% for all treatments in Parts A and B, respectively, with no significant differences between arms in either part. In healthy and screening colonoscopy subjects, the new low volume, split-dose bowel preparation NER1006 achieved high quality bowel cleansing comparable with MOVIPREP^®. Stool output was consistently higher with NER1006 treatments. Safety/tolerability profiles between treatments were comparable.
 

Phase III clinical programme

The Phase III programme will investigate the bowel cleansing efficacy, compliance, safety, patient acceptability and tolerability of NER1006. The NOCT study is a US multicentre, randomised, parallel-group clinical trial that is expected to enrol 540 patients across two arms. The MORA study in Europe will compare NER1006 versus MOVIPREP^® using a 2-day split-doing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study also in Europe will compare NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET^®) using a day before only dosing regimen in adults. Enrolment for trials MORA and DAYB are planned to start in late 2014.
 

About MOVIPREP^®

MOVIPREP^® (2L polyethylene glycol + ascorbate) is an effective bowel cleanser which is indicated for bowel cleansing prior to any clinical procedures requiring a clean bowel, e.g. bowel endoscopy or radiology.[6] MOVIPREP^® is a registered trademark of the Norgine group of companies.
 

About Norgine

Norgine is a European specialist pharmaceutical company that has been established for over 100 years.In 2013, Norgine’s total revenue was €274 million and the company employs over 1,000 people.

Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.

Norgine is headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns an R&D site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in 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.
 

For further information, please contact:
Charlotte Andrews: Tel: +44 (0)1895 453669, Mob: +44 (0)7714 061485
Peter Martin: Tel: +44 (0)1895 453744, Mob: +44 (0)7799 078744
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