Patheon to Manufacture Pharmalink’s IgA Nephropathy Product
Swedish specialty pharma firm Pharmalink has contracted Patheon to provide development and manufacturing services for its lead clinical-stage product, Nefecon® (PL-56), which is in development to address the pathology of IgA nephropathy, the most common form of primary glomerulonephritis and a cause of end-stage renal disease. Announcement of the contract comes 24 hours after contract developer and manufacturer Patheon reported a $255 million deal to buy oral dosage specialist Banner Pharmacaps.
Pharmalink’s Nefecon is an enteric formulation of a locally acting corticosteroid, which is designed to downregulate the disease process in the kidney by suppressing the gastrointestinal immune system. Nefecon has successfully completed Phase II open-label safety and efficacy studies, and is in preparation for Phase III trials.
Originally developed by researchers at Uppsala University, Pharmalink’s formulation is delivered using Archimedes Pharma’s Targit® technology for the localized delivery of drugs to the lower small intestine or colonic regions of the gastrointestinal tract. Pharmalink licensed the Targit platform for use with Nefecon in December 2011, following a longstanding co-development program with Archimedes.
Pharmalink is focused on the repurposing and reformulation of established drug molecules to generate new products. The firm’s clinical pipeline is headed by Nefecon, and Busulipo® (MZH-2), which is in development as a conditioning agent for use prior to bone marrow transplantation. Originally developed as a concept by researchers at the Karolinska Institute in Sweden, Busulipo is a liposome/lipid complex formulation designed to improve the safety and stability of busulfan, a chemotherapy agent that is currently the gold standard for use in conditioning prior to HSCT. Busulipo has completed a number of clinical studies, and is being prepared for registrational trials.
At the start of 2012 Pharmalink raised SEK 35 million (about $5.2 million) through a rights issue of new shares, to support further development of Nefecon and Busulipo.