U.S. sales of Johnson & Johnson's (J&J) erythropoiesis-stimulating agent (ESA) Procrit remained steady during the first quarter of 2007 despite recent drug safety issues associated with the use of ESAs.
J&J announced April 17 that first-quarter sales for Procrit (epoetin alfa) increased 1 percent to $530 million, compared with $527 million in the first quarter of 2006. Worldwide sales for the product increased 4 percent for the quarter, totaling $817 million, with 11 percent sales growth outside the U.S.
"Procrit share was approximately 44 percent in the first quarter of 2007 compared [with] 45 percent share in the first quarter of 2006. Share is up 1 point on a sequential basis from the fourth quarter last year due to positive results in the hospital and retail markets," Louise Mehrota, J&J vice president of investor relations, said.
Although the company noted that the hospital and retail markets for the product were growing and that Procrit benefited from marginally positive pricing, Mehrota said that "there is some downward pressure due to the label change."
"It's really early to speculate on whether the declines will be hefty or not," Dominic Caruso, J&J's chief financial officer, added. "We want to wait and see what the outcome of the [Oncologic Drugs Advisory Committee] meeting in May is."
The FDA scheduled the meeting to discus warning language added to labeling for Procrit and Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa). The meeting is scheduled for May 10.
Following the FDA announcement, the Centers for Medicare & Medicaid Services said it was reevaluating its reimbursement policies for ESAs in both the oncology and renal-failure settings.