Pharmalink AB, a specialty pharma company focused on orphan and niche products, 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 (www.nefigan.net). 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.
Johan Häggblad, Managing Director of Pharmalink, said:
“Nefecon is a disease-modifying medication and one of the first specifically aimed at addressing the underlying pathology of progressive IgA nephropathy. The issuance of core patents in key global markets reinforces the commercial package we are building around Nefecon.”
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).