Keryx Biopharmaceuticals (KERX) located in NYC, develops products for the treatment of renal disease. A lead product is Zerenex, (ferric citrate), an oral ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes.
Significant is that the company has a Phase 3 clinical program for Zerenex for the treatment of hyperphosphatemia, elevated phosphate levels, in patients with end-stage renal disease. This is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. The company is waiting for top-line results. Management expects U.S. NDA and European MAA filings to follow result disclosures. Notably, the company is also conducting a Phase 2 trial for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease.
A third positive is that the company's partner in Japan, Japan Tobacco Inc. (JAPAF.PK) and Torii Pharmaceutical Co., Ltd., (TRXPF.PK) has just filed its New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease.
The NDA filing is supported by efficacy and safety data from several successfully completed Phase 3 studies in CKD patients with hyperphosphatemia in Japan. Under the license agreement with JT and its subsidiary Torii Pharmaceutical Co., Ltd. (Torii), within 30 days, Keryx will receive a non-refundable payment of $7 million for the achievement of the NDA filing milestone.
Renal Disease Information
Data about Renal disease includes that there are roughly 485,000 patients with end-stage renal disease (ESRD). Projections by experts for growth of the disease include a rise of 60% to approximately 785,000 by the year 2020. Most ESRD patients require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and the progression of renal failure. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels.
Keryx's past deals and current progressive moves and agreements will impact the company in a very positive manner. Back in 2007, when the company sub-licensed to JT and Torii the exclusive rights for Zerenex, the licensing arrangement called for JT and Torii to pay to Keryx up to $100 million in up-front license fees and payments upon the achievement of specified milestones, of which $35 million has been received by Keryx to date (including the 7 million milestone of recent). One third of the way into those specified payments, they are moving towards commercialization. JT and Torii will make royalty payments to Keryx on net sales of the drug in Japan and are responsible for all development and commercialization costs. These factors and pending commercializations should provide a steady revenue stream and uptick opportunities for the NY-based firm.
Keryx has a 52 - week range of $1.28 to $5.19 and is currently trading at $2.92 and a Market Cap of $210 Million.