Pharmalink AB has had core patents for its late-stage clinical candidate Nefecon® issued in the key markets United States, Europe, China and Hong Kong. A patent is pending in Japan.
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. Pharmalink recently completed patient enrolment of this study, which 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.
The patents issued in the US (US 8,491,932), Europe (EP 2278958) China (200980127272.5) and Hong Kong (1158510) provide protection around the formulation of Nefecon and its use as a treatment of glomerulonephritis, including IgA nephropathy, the most common form of primary glomerulonephritis and a cause of end-stage renal disease. The formulation technology, TARGIT®, was licenced by Pharmalink for exclusive use with Nefecon under a 2011 agreement with Archimedes Development Ltd (UK). The suite of recently issued patents are the result of a very productive formulation development partnership between the companies.