Norgine R&D

The Norgine Research & Development (R&D) department was established in 1998, with a key strategic focus in the following therapeutic areas:

Gastroenterology
Hepatology
Incontinence

Although Norgine does not have primary discovery capabilities, we actively seek collaborations with universities and research institutions for early stage candidate identification and development opportunities.

Development projects are managed using our internal expertise in project management, employing cross-functional project teams and utilising our internal strengths in the areas of product development, clinical development and regulatory affairs to take projects from concept through to regulatory approval. Another area of competency is the management of an extensive network of external development partners and experts who we engage in outsourcing activities in support of product development.

A new technical development facility is currently being built at Norgine’s manufacturing site in South Wales. This facility will be dedicated to supporting new product development and will include a development laboratory, a Good Manufacturing Practice manufacturing area, an investigational medicinal product suite, a fully equipped analytical laboratory, bench area, stability cabinets and office space for the technical development scientists. The facility is expected to be fully operational in 1Q2009.

Norgine’s development pipeline includes the following projects:

Phase of Development Indication
Research Inflammatory bowel disease
Exploratory Development Faecal incontinence
Non-alcoholic steatohepatitis
Inflammatory bowel disease
Clinical (Phase I – III) NRL972
NRL001
Anal fissures
Faecal incontinence
Urinary incontinence
Line Extensions Supporting Norgine’s licensed products

NRL972 is a liver staging tool, currently in Phase III clinical development in Europe and under an IND in Phase II clinical development in the US.

NRL001 is in Phase I clinical development as a treatment for faecal incontinence.