Page 12 - norgine-annual-report-2016

®
Norgine launched MUGARD in the UK and Spain and under the name of MUCOGARD in
®
Australia. Further launches are anticipated in Norgine’s territories in 2017.
MUGARD is a mucoadhesive oral rinse proven to prevent and manage the lesions and symptoms
®
of oral mucositis by adhering to the mucosal surface of the mouth and forming a soothing, protective
layer. Approximately 20-40% of patients receiving conventional chemotherapy and nearly all patients PLENVU (NER1006) is a novel, low volume polyethylene glycol (PEG)
®
receiving head and neck radiation therapy suffer from oral mucositis. With limited effective treatment 3350-based bowel preparation that has been developed by Norgine to provide
options available, MUGARD has been created for patients to take prior to and during cancer whole bowel cleansing, with a focus on the ascending colon.
®
treatment to relieve the signs and symptoms of oral mucositis.
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.

In 2016, Norgine reported three positive studies from its phase II programme:

Further to the acquisition of additional distribution rights for ZIVEREL • NOCT study. A U.S. study that compares PLENVU versus a trisulfate bowel
®
®
in April 2016, Norgine prepared for the launch of the product in all cleansing solution (SUPREP ) using a 2-day split-dosing regimen in adults.
®
of its territories. Both primary endpoints were met, achieving non-inferior overall bowel cleansing
success and ‘Excellent plus Good’ cleansing of the colon ascendens using
ZIVEREL is a medical device (class III) used to maintain the integrity
®
the Harefield Cleansing Scale (HCS). PLENVU demonstrated an acceptable
®
of the oesophageal mucosa to avoid the irritation of the oesophagus
safety profile.
9
caused by stomach acid among other causes.
• MORA study. A European study that compares PLENVU versus a 2L PEG
®
Gastroesophageal reflux disease is prevalent worldwide, and the
(MOVIPREP ) with ascorbate bowel cleansing solution using a 2-day split-
®
burden of the disease may be increasing. It affects up to 20% of the
dosing regimen and a 1-day morning split-dosing regimen in adults. The study
Western population and is associated with a range of risk factors. 8
met both primary endpoints showing that when administered as either a 2-day
overnight or 1-day morning split-dosing regimen, and compared to 2L PEG,
8. J Dent et al. Gut 2005;54:710-717 doi:10.1136/gut.2004.051821. http://gut.bmj.com/content/54/5/710.full
PLENVU was non-inferior in achieving overall bowel cleansing, and non-
®
inferior and superior in achieving ‘Excellent plus Good’ cleansing of the colon
ascendens. PLENVU demonstrated an acceptable safety profile. 10
®
• DAYB study. A European study that compares PLENVU versus a sodium
®
picosulfate and magnesium salt solution (CITRAFLEET ) using a day before
®
Priority 2: only split-dosing regimen in adults. Although the study met both primary
endpoints, demonstrating non inferiority, the data will contribute to safety
Strengthen the late stage pipeline evaluation only. The study used a dosing schedule for the comparator that is
not relevant to current medical practice in U.S. PLENVU demonstrated an
®
Acquiring and developing new transformative acceptable safety profile. 11
products that will change medical care and
add value to patients and payers is a priority
for Norgine. In 2016, Norgine continued to
9. DeMicco M, et al. OP375 Efficacy and safety of the novel 1L PEG and ascorbate bowel preparation
make progress in the development of its NER1006 versus trisulfate solution in overnight split-dosing administration: results from the phase 3 study
NOCT. UEG Journal 2016; 4(Suppl1): A415-A416.
®
pipeline, in particular for PLENVU and 10. Bisschops R, et al. P0179 Efficacy and safety of the novel 1 L PEG and ascorbate bowel preparation
NER1006 versus standard 2 L PEG with ascorbate in overnight or morning split-dosing administration:
results from The phase 3 study MORA. UEG Journal 2016; 4(Suppl1): A218-A219.
LYMPHOSEEK . 11. Schreiber, et al. P1266 Efficacy and safety of the novel 1 L 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(Suppl1): A589-A590.
11 12