Pharmalink AB has announced that it has entered into a contract with Patheon Inc., a leading provider of contract development and manufacturing services to the global pharmaceutical industry for the manufacturing of Nefecon®, Pharmalink’s lead product.
Nefecon is being developed as the first on label medication specifically aimed at addressing the underlying pathology of progressive IgA nephropathy, the most common form of primary glomerulonephritis and a leading cause of end-stage renal disease.
The agreement covers the manufacturing of Nefecon and is an important step in progressing the product towards the market. No commercial terms were disclosed.
Johan Häggblad, Managing Director of Pharmalink, said: “Despite the increasing recognition of IgA nephropathy as a significant cause of morbidity and mortality, no specific medications have been developed and introduced to the market. In that context, our development programme for Nefecon is seen as one of the most significant in IgA nephropathy clinical research. We have already shown positive results in an open-labelled Phase II trial evaluating Nefecon’s safety and efficacy and, with Patheon we will be working with one of the pharmaceutical industry’s best respected manufacturers as Nefecon advances towards pivotal trials.”
Nefecon is an enteric formulation of a locally-acting and potent corticosteroid which down regulates the IgA nephropathy disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response.
The target group for Nefecon is the approximately 40% patients with the more aggressive form of the disease and who are at risk of developing end stage renal disease.
The ultimate aim is to provide an alternative to dialysis and transplantation. Pharmalink has received orphan drug designation by the US Food and Drug Administration (FDA) for Nefecon.
Nefecon was invented at Uppsala University (Sweden) and was acquired by Pharmalink in 2004.
Nefecon® is delivered using the proprietary TARGIT® drug delivery technology which enables the localized delivery of drugs to the lower small intestine or colonic regions of the gastrointestinal tract.
Pharmalink has an exclusive licence to Targit® technology for the development of Nefecon® from Archimedes Pharma.