In the late 1990s, Wixom, MI-based Rockwell Medical revolutionized the dialysis industry by being the first to develop, patent, and bring to market a dry acid mixing system for hemodialysis concentrate. It eliminated the need for the bulky 55-gallon drums that were the industry standard at the time. Now, CEO Rob Chioini believes the company is prepared to disrupt the market again with a product that will significantly decrease the need for expensive erythropoietin stimulating agents (ESAs), drugs that treat anemia in kidney dialysis patients.
Currently in Phase 3 trials nearing completion, Rockwell’s drug Soluble Ferric Pyrophosphate (SFP) is an iron salt administered to dialysis patients through dialysate to replace the iron lost during dialysis. Chioini says once in the dialysate, SFP enters the bloodstream and binds to apo-transferrin before being taken to the bone marrow, mimicking the way dietary iron is processed in the human body. Compare that to the current method, where the iron is injected into dialysis lines encased in a carbohydrate shell. That iron must go through the liver, causing a potentially adverse effect if too many carbohydrates build up in the liver.
In February, Rockwell released data from a nine-month study in the United States that randomized 108 patients equally to dialysate containing SFP-iron versus conventional dialysate. The study found that SFP reduced the need for ESAs like Amgen’s epoetin alfa (Epogen) during hemodialysis by 37.1 percent. On May 19, Rockwell will present the results of the study at the prestigious European Renal Association – European Dialysis and Transplant Association Congress in Istanbul.
Rockwell is also preparing to launch Calcitriol, an FDA-approved generic drug to treat secondary hyperparathyroidism in dialysis patients. Calcitriol’s active ingredient is vitamin D, which Chioini says is one of the three main drugs used in dialysis along with epoetin alfa and intravenous iron.
Representing a combined $950 million market, Chioini believes SFP and Calcitriol will be game changers for Rockwell Medical. In 2011, the government changed its reimbursement rules. Before 2011, dialysis centers would receive a payment for the dialysis treatment and then an additional payment reimbursing the clinic for the drugs used. As a result, Chioini says, providers used the most expensive drugs possible to bump up the reimbursement amount. Now, the government gives one lump payment to cover everything. “That’s very beneficial for Rockwell because both of our drugs lower costs,” he adds. “We expect to do really well.”
Chioini is also feeling confident because of a national product supply deal Rockwell announced this week with DaVita, one of the nation’s largest dialysis providers. Covering a five-year period, it will significantly increase the number of DaVita dialysis centers using Rockwell products.
As Rockwell waits for the Phase 3 clinical trials to be completed—one finishes this month, while the other one wraps in August—Chioini says the company is ready for all it has invested in bringing these products to market to pay off. “We’re moving along, ready for the next big event to occur,” he says.
