CORPORATE PRESS RELEASE
NORGINE ENROLS FIRST PATIENTS IN EUROPEAN PHASE III STUDIES TO EVALUATE BOWEL CLEANSING EFFICACY OF NER1006, A NOVEL, LOW VOLUME BOWEL PREPARATIONion
LONDON, UK, Thursday 13 November 2014, 07:00 GMT – Norgine today announced the enrolment of the first patients into two European Phase III studies (MORA and DAYB) for its investigational product NER1006. The MORA study will evaluate the bowel cleansing efficacy* of NER1006 versus MOVIPREP® using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study will also evaluate the efficacy* of NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults. The MORA and DAYB studies will also assess the compliance, safety, patient acceptability and tolerability of NER1006.
NER1006 is a novel, low volume polyethylene glycol 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 (1 L**, of bowel preparation solution with 1 L** 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.
The MORA and DAYB studies are part of Norgine’s NER1006 Phase III clinical trials programme. Both MORA and DAYB are European*** multicentre, randomised, parallel-group clinical trials that are expected to enrol approximately 1,294 patients in total. The Phase III programme also includes a clinical study in the United States, NOCT, which will compare NER1006 versus a trisulfate bowel cleansing solution (SUPREP®) using a 2-day split-dosing regimen in adults. Enrolment for the NOCT trial commenced in September 2014.
Donna McVey, Chief Development Officer, Norgine, commented: “We are pleased that the first patients have now been enrolled into the European studies which aim to demonstrate that NER1006 can improve patient acceptability and compliance. These pivotal trials complement the data already available for this novel preparation, and further strengthen our bowel cleansing portfolio.”
Notes to Editors
* The following primary endpoints will be investigated by the MORA and DAYB studies:
The overall bowel cleansing success rate of NER1006 compared to MOVIPREP® / CITRAFLEET®, as graded by the Harefield Cleansing Scale (HCS), wherein success corresponds to Grades A and B, and failure corresponds to Grades C and D.
The “Excellent plus Good” cleansing rate in the colon ascendens of NER1006 compared to MOVIPREP® / CITRAFLEET® 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.
** 1 litre / approx. 32 US fluid ounce
*** The following EU countries will be included in the MORA and DAYB clinical trials:
MORA: Belgium, France, Germany, Italy, Poland, Spain and UK
DAYB: Germany, Italy, Netherlands, Poland, Spain and UK
About NER1006 phase II clinical programme
The open-label, randomised, two-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). In screening colonoscopy subjects, the new low volume, split-dosing bowel preparation NER1006 achieved high quality bowel cleansing comparable with MOVIPREP®. Stool output was consistently higher with NER1006. For subjects who completed dosing, vomiting rates were 6.7% and 3.3% for all treatments in Parts A and B, respectively, with no significant differences between arms in either part. Safety/tolerability profiles between treatments were comparable. The results of this study were presented at the 79th Annual Scientific Meeting of the American College of Gastroenterology (ACG), Philadelphia, PA, 17-22 October 2014.
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
Follow us @Norgine
 Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations From the US Multi-Society Task Force on Colorectal Cancer. A joint guideline from the American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy. The American Journal of Gastroenterology. 2014
 Halphen M, et al. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013;78:121-31