Value-added generic development
Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products. Typically, our clients approach us with a specific development request but occasionally, we are also asked to investigate and propose new product opportunities based on the existing drug portfolio of our clients. Although in general the overall aim of value-added generic development projects is focused on improving the safety, efficacy and/or the ease of administration, we are also specialized in executing development programs where the primary or sole objective is the evasion of existing product patents.
Case study – Reformulation project
Pouchitis is the most frequent complication of ileal pouch-anal anastomosis (IPAA). In Europe and the United States, the condition is estimated to affect the lives of respectively 150.000 and 80.000 patients.
In collaboration with the Department of Gastroenterology of the University of Leuven, Avivia BV has developed a modified release formulation of metronidazole (MRZ) for the treatment of pouchitis. This formulation aims for a lower systemic and higher local exposure to MRZ, with non-inferior efficacy to standard of care MRZ immediate release (IR) yet at a lower dose making for a more effective treatment with decreased treatment burden, increased quality of life for patients and the potential for chronic or repeated treatment episodes.
The socio-economic impact is related to the avoidance of expensive and burdensome additional surgery and treatments (e.g. biologics) as well as a reduced evolution to chronicity.
Orphan drug designation of MRZ for pouchitis has been granted by the FDA and the COMP.