Norgine’s pipeline is predominantly focused upon our core therapy area of Gastroenterology and associated diseases such as Hepatology. Although Norgine does not have primary discovery capabilities, we actively seek collaborations with research institutions for early stage candidate identification and development opportunities.
Norgine’s development pipeline includes the following projects:
NRL972 is a compound which is being developed to detect liver disease, and to assess the severity of liver damage. Although various liver function tests currently exist, single tests mostly fail to detect early (mild) stages of liver disease, and do not allow the clinician to differentiate between stages of disease severity, or to characterise the progression or regression of disease. NRL972 is intended to be a validated diagnostic tool that specifically identifies early stages of the disease and the associated functional abnormalities.
NRL972 is currently in Phase III development in Europe and Phase II development in the United States.
NRL001 is a compound which is being developed for the treatment of passive faecal incontinence.
Faecal incontinence involves the involuntary loss of solid or liquid stool (faeces) or gas from the anus. Contrary to common belief, the condition is not confined to the disabled elderly; faecal incontinence can affect otherwise healthy individuals of all ages. Some cases are due to anatomical damage to the anal sphincter associated with childbirth or ano-rectal surgery.
However, in many patients there is no distinct structural damage to the anus; in such cases, faecal incontinence appears to be a degenerative disorder affecting the smooth muscle, the internal/external anal sphincters, which control the function of the anal canal.
Present estimates suggest that about 2% of the general population might have difficulty in controlling solid stool and up to 9% in controlling liquid stool, but that only about one in eight affected subjects consults their doctor, even though the condition causes embarrassment, distress and an impaired quality of life. It is believed that NRL001 will provide a new option for the treatment of this debilitating condition.
Having completed a range of healthy volunteer studies with NRL001, the compound is in Phase II development.
Norgine has a licensing agreement with Alpha Wasserman with regard to XIFAXAN. XIFAXAN is rifaximin, a non-absorbed antimicrobial agent belonging to the rifamycin group. Norgine has the rights in a number of European and Middle Eastern markets. Currently, Norgine holds licences to sell XIFAXAN in several countries, where it is indicated for the treatment of adult patients with travellers diarrhoea caused by non-invasive enteric pathogens.
Travellers diarrhoea describes a clinical picture predominantly observed in subjects travelling from developed to developing countries. It is most frequently caused by enterotoxigenic Escherichia coli (ETEC), enteroaggregative E. coli (EAEC) and other non-invasive pathogens. Norgine is also investigating the development of XIFAXAN in a number of other indications.
Norgine has acquired the worldwide rights to CAMETOR (cetilistat). CAMETOR is being developed for the treatment of obesity with our partners Takeda, who are responsible for developing and marketing the product in Japan and are currently conducting Phase III studies there.