STOCKHOLM, July 10, 2014 /PRNewswire/ —
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 (http://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).
Pharmalink is a Swedish specialty pharma company developing high value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical development and marketing to identify and progress products that address significant unmet medical needs. With a successful history in pharmaceutical sales and marketing, and highly experienced, dynamic management team, Pharmalink is focused on the development and commercialization of valuable, de-risked projects. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™. Pharmalink is actively seeking opportunities to acquire or in-licence product opportunities in niche and hospital care indications. Visit http://www.pharmalink.se for further information.
About IgA Nephropathy
IgA nephropathy is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage.
IgA nephropathy can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that 20-40% of patients with IgA nephropathy progress to renal failure, often referred to as end-stage renal disease within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets.
Patients suffering renal failure require dialysis or kidney transplantation. IgA nephropathy accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.
About the Nefigan trial
The Nefigan trial is a multicenter, randomized, double-blind, placebo controlled study conducted at more than 60 centers in ten European countries. The objective of the study is to evaluate efficacy and safety of two different doses of Nefecon in the treatment of patients with primary IgA nephropathy at risk of developing end-stage renal disease (ESRD), under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).
Read more at http://clinicaltrials.gov/ct2/show/NCT01738035