For quite some time, anemia drugs developed by Amgen (AMGN) and Johnson and Johnson (JNJ) have been under the US Food and Drug Administration (FDA) scanner. Recently, the agency announced a new safety plan for both the companies related to the use of these drugs, also known as erythropoiesis–stimulating agents (ESAs), on cancer patients. ESAs are approved for the treatment of anemia that might arise out of kidney failure from certain kinds of chemotherapy.
As part of the Risk Evaluation and Mitigation Strategy (REMS), healthcare professionals should provide their patients a Medication Guide explaining the risks related to these drugs. In addition, under the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program, to be launched on March 24, health care professionals are required to undergo specific training and obtain necessary certification.
While Johnson and Johnson has one ESA, Procrit, Amgen has two ESAs in its product portfolio, Aranesp and Epogen. Further review of these drugs became necessary as studies conducted over the past few years have shown that high doses could lead to heart complications or death in some cases. Accordingly, the FDA ordered strong warnings on product labels, which further reduced their sales.
During the fourth quarter, Amgen’s ESA franchise contributed 35% to total revenues. Aranesp sales declined 8% year over year to $648 million (US – $288 million, down 20%; ex-US – $360 million, up 4%), mainly due to a decline in demand reflecting the negative impact, primarily in the supportive cancer care setting, of additional product label changes, which were introduced in August 2008. Epogen sales increased 9% to $703 million reflecting an increase in demand, which was supported by patient growth and an increase in average net sales price.
Meanwhile, Procrit recorded an 8.7% drop in sales ($2,245 million) during 2009 primarily due to the declining markets for ESAs in the U.S. Although sales from Aranesp and Epogen are quite crucial for Amgen, Johnson and Johnson is less dependent on Procrit, which contributed about 10% and 3.6% to pharmaceutical business revenue and total revenues, respectively during the full year.
The inclusion of a safety-related boxed warning on the labels of Amgen’s Aranesp and Epogen and Johnson and Johnson’s Procrit has had an adverse impact on the sales of these products. The introduction of the REMS is likely to restrict sales further.
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