Sweden-based Pharmalink has signed a manufacturing contract with Patheon for Nefecon that is in development to address the pathology of IgA nephropathy.
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Nefecon, an enteric formulation of a locally-acting and potent corticosteroid, inhibits the gastrointestinal immune system and down regulates the IgA nephropathy disease process.
Commercial terms of the agreement were not revealed.
Pharmalink managing director Johan Haggblad 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.
"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," Haggblad added.
The FDA granted orphan drug designation for Nefecon which is delivered using a Targit drug delivery technology that allows localized delivery to the lower small intestine or colonic regions of the gastrointestinal tract.
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