A New Type of Anemia Drug

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A new type of erythropoietin product may be coming soon for patients with chronic and advanced kidney disease in whom anemia may develop.

AstraZeneca, the second largest pharmaceuticals firm in the United Kingdom, had a dwindling drug pipeline and has completed a deal with FibroGen, a biotechnology company in the United States, for an experimental anemia drug, several news outlets reported recently. AstraZeneca paid for rights to a drug that could be worth more than $815 million.

FG-4592 is the name of the new compound, which is delivered in pill form rather than the conventional injection for anemia brought on by chronic kidney (CKD) disease and end stage renal disease (ESRD).

The treatment is the first of a new type of drug for kidney patients that boosts the production of red blood cells by making the body react as if it is at high altitude and needs more cells for oxygen delivery.

Pharmaceutical researchers believe that such drugs could create a new market in treating anemia and other serious conditions, including circulatory problems and wound damage, Reuters reported. The drug may someday be developed for other anemia conditions, AstraZeneca said on its website.

Right now, AstraZeneca will pay $350 million up front, plus development-related milestone payments of up to $465 million, for a total of $815 million for rights to FG-4592 in the United States, China, and selected markets. The Reuters news service said that there could be additional payments “if use of the drug is expanded beyond the initial target of treating anaemia [sic] in patients with chronic kidney disease and end stage renal disease.”

The drug is a small-molecule compound that stops the activity of hypoxia-inducible factor prolyl hydroxylase in anemia patients with CKD. According to AstraZeneca, the drug brings about a natural response to conditions of low oxygen and turns on the process of making red blood cells. FG-4592 has been shown to correct anemia and maintain hemoglobin levels “without the need for supplementation with intravenous iron in CKD patients not yet receiving dialysis and in end stage renal disease patients receiving dialysis,” the company noted.

Thomas B. Neff, chief executive officer of FibroGen, said that FG-4592 could offer anemia patients an easier oral therapy “that provides coordinated erythropoiesis [production of red blood cells], that increases natural erythropoietin within the normal physiological range, and that is effective without intravenous iron supplementation and without an increased risk for hypertension.”

Neff said that AstraZeneca and FibroGen would make China the first-to-launch country for FG-4592 and that the companies want to innovate in the area of anemia therapy to CKD and ESRD patients in the United States, where clinical trials would be fully funded under the terms of the agreement.

Pascal Soriot, AstraZeneca’s chief executive officer, said that the collaboration on FG-4592 is “an important addition to AstraZeneca’s growing late-stage portfolio in cardiovascular and metabolic disease,” one of the company’s core therapy areas. “We know from our research into complications of renal disease that anemia continues to be a challenge for patients with chronic kidney disease, due in part to the inconvenience and complexity of existing injectable and intravenous therapies and the safety concerns associated with them,” Soriot said.