According to industry research, 508,570 end-stage renal disease (ESRD) patients received dialysis treatment in the U.S. in early 2016, and 2.82 million total worldwide, with forecasted 5-7% annual growth to 2020.
During the 4-hr hemodialysis treatment procedure, patients lose an average of 5-7 mg of iron, resulting in a condition called iron-deficiency anemia. Managing anemia in dialysis patients is necessary and can be improved over current IV iron administration. Triferic replaces the 5-7 mg of iron lost during every dialysis treatment and effectively addresses the current challenges in anemia management by:
- Maintaining hemoglobin (Hgb) levels within a safe range using moderate ESA doses
- Improving response to ESA therapy, while avoiding excessively high doses and potential risks
- Preventing iron from being stored in the liver thereby avoiding liver toxicity
- Reducing current drug administration costs
Triferic delivers iron slowly and continuously in a physiologic manner during every hemodialysis session. Triferic is infused directly into the bloodstream in a small, continuous dose three times per week and replaces the 5-7 mg of dialytic iron that is lost during every dialysis treatment. This mode of delivery maintains patient hemoglobin within a target range while reducing ESA utilization. With current IV iron therapy, iron levels are not always adequate when ESA’s are dosed and therefore greater ESA doses are needed; this is believed to contribute to hemoglobin cycling or variability and related adverse patient consequences.
Triferic’s unique properties enable it to not increase iron stores (ferritin) after dosing. Avoiding iron storage in the liver eliminates toxicity, inflammation and infection normally associated with current IV iron delivery. It is believed that over 50 percent of the IV iron that is dosed to a patient stays trapped in the liver and over time may cause adverse consequences. (Source: Coyne DW, Kapoian T, Suki W, et al. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of dialysis patients' response to IV iron with elevated ferritin (DRIVE) study. JASN. 2007;18:975-984.)
In addition to the potential to provide significant patient benefit and improved patient outcome, Triferic reduces related administration costs considerably. Because Triferic is introduced into the bicarbonate in a powder form on-site at the dialysis clinic, which is subsequently mixed into dialysate, required supplies such as needles, syringes, gloves and bio-hazardous waste disposal needed for current IV therapy are avoided, as well as nursing time to deliver and manage IV iron. The Triferic powder packet is similar to the size of a packet of sugar to significantly reduce clinic storage space. It's much smaller and lighter to lower shipping costs and the number of reorders to maintain inventory.
Furthermore, because Triferic continously maintains the patient's iron balance, as opposed to IV iron which is dosed infrequently to replenish iron after hemoglobin has dropped below a certain threshold, ESA dose is expected to be significantly reduced, which should result in considerable savings to the dialysis provider. In 2015, almost $2 billion was spent on ESA in the U.S. dialysis industry alone and $5.5 billion world-wide.
The U.S. Food & Drug Administration approved Triferic on January 24, 2015 and was launched commercially in the U.S on September 9, 2015. The Company's estimated U.S. addressable iron market to treat anemia in ESRD patients is $300-600 million and $1+ billion world-wide, with forecasted growth 5-7% annually to 2020.