Pharmalink AB, a specialty pharma company focused on orphan and niche products, has had an important patent for its late-stage clinical candidate Nefecon® granted in Japan (5608641). Key patents protecting Nefecon have also been granted in the United States, Europe, China and Hong Kong, giving Pharmalink strong patent protection for Nefecon in key pharmaceutical markets around the world.
Nefecon is a potential disease-modifying treatment for patients with primary IgA nephropathy at risk of developing end-stage renal disease. Nefecon has shown positive results in an open-labelled Phase II trial evaluating safety and efficacy and is now being tested in a placebo-controlled randomized Phase IIb study (www.nefigan.net). The study has been designed to enable an optimal dose of Nefecon to be selected for a Phase III registration trial. Headline data is anticipated in Q3 2015.
Nefecon is an enteric formulation of a locally-acting and potent corticosteroid that down-regulates the 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. Early treatment with Nefecon of patients with primary IgA nephropathy at risk of developing end-stage renal disease may slow or halt disease progression and further loss of renal function, and provide an alternative to dialysis and transplantation. Nefecon has received orphan drug designation by the US Food and Drug Administration (FDA).