On March 27, the FDA approved Affymax's Omontys® (peginesatide) for use in adult dialysis patients with anemia caused by chronic kidney disease. Anemia is a condition characterized by a decrease in the level of red blood cells in the body. Healthy red blood cells carry oxygen to the body's organs and tissues, and when the level of red blood cells is decreased, the organs are not able to function properly. The kidneys produce the hormone erythropoietin, which directs the bone marrow to produce enough red blood cells to support the body. Diseased kidneys do not produce enough erythropoietin, and as a result, the bone marrow does not produce enough red blood cells, causing anemia. There are currently close to 400,000 patients on dialysis, and almost all of them have anemia.
Amgen has held a monopoly on the anemia market, yielding close to $40 billion since Epogen®'s (epoetin alfa) approval in 1989. Amgen supplies the same drug under the name Procrit® to Johnson and Johnson for use in chemotherapy patients with anemia and for non-dialysis kidney patients. Amgen also produces the drug Aranesp®, a longer-lasting anemia drug used mainly in non-dialysis patients, which has made close to $26 billion in sales since it entered the market.
Omontys® is a synthetic erythropoietin-stimulating agent that assists the body in increasing red blood cell production. Prior to the approval of Omontys®, the only treatment choice for dialysis patients with anemia was Amgen's Epogen®. Epogen® is an injection usually given between one to three times weekly. Omontys®, on the other hand, is an injection given once monthly, which has demonstrated equivalent safety and efficacy to Epogen® treatment.
On June 24, 2011, the FDA released a press announcement modifying the dosing recommendations for erythropoiesis-stimulating agents due to an increase in cardiovascular events. A new warning was added to the package inserts which now state, "Physicians and their patients with chronic kidney disease should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions against the increased risks for serious adverse cardiovascular events. For each patient, individualize dosing and use the lowest dose of ESA sufficient to reduce the need for transfusion." The decrease in dosing frequency of Omontys® is consistent with the FDA's goal in lowering the frequency of cardiovascular events occurring as a result of treatment with erythropoesis-stimulating agents such as Epogen®.
As Medicare pays for most dialysis treatment, even for patients under age 65, the cost of erythropoesis-stimulating agents is very important. Prior to the approval of Omontys®, Amgen was able to adjust its prices as it pleased. In an attempt to prevent Omontys® from entering the market, Amgen has entered into supply agreements with the two largest dialysis chains. Omontys® will still be an option for 3/4 of dialysis patients. Affymax CEO John Orwin says. The price of Omontys® will be close to that of Epogen® on a milligram to milligram basis, however the decreased dosing frequency will lead to a lower cost overall. Affymax entered a marketing agreement with Takeda and all U.S. Omontys® business will be split 50-50 between the two companies. Omontys® is Affymax's first marketed product.