Johnson & Johnson
, in consultation with French regulators, said Monday it is altering the prescribing information for its anemia drug Eprex to include a strict warning against subcutaneous use in kidney dialysis patients. Instead, the drug will be administered intravenously.
The Eprex label change comes as European drug regulators are reportedly considering a total ban on the use of Eprex in patients with chronic kidney failure, according to a story in Saturday's
New York Times
Eprex has been linked to about 160 cases of pure red cell aplasia, a serious condition in which the body's immune system attacks its own red blood cells. Nearly all the cases have occurred in European patients taking Eprex via subcutaneous injection, and Johnson & Johnson had already sent letters to doctors urging them to give the drug via IV.
Eprex is not sold in the U.S., nor has it caused problems with pure red cell aplasia in cancer patients undergoing chemotherapy, the drug's other key market.
Shares of Johnson & Johnson were off 3% to $55.20 in Monday trading on fears that a possible Eprex ban would impact the drugmaker's bottom line.
Sales of Eprex were $1.1 billion in 2001 and $300 million in the third quarter, with sales to kidney dialysis patients accounting for half of that total, according to Johnson & Johnson. Trying to allay some fears, the company said that, already, 70% to 80% of kidney patients already have switched to IV administration of Eprex.
Johnson & Johnson said the Eprex label change would not impact current-year earnings. The company reiterated 2003 earnings guidance of $2.61 per share.
shares were up 1.7% to $48.01 Monday on hopes that its rival anemia drugs would gain European market share due to Eprex's problems. Banc of America Securities analyst Mike King, in a Monday report, said Amgen's newest anemia drug, Aranesp, in particular, might benefit from increased use because it can be given via subcutaneous injection without fear of pure red cell aplasia. King rates Amgen buy and his firm doesn't have a current banking relationship with the company.
Last week, Amgen CEO Kevin Sharer told various fund managers at a luncheon that the company has yet to see Aranesp steal significant market share from Eprex over the pure red cell aplasia issue, according to two fund managers in the audience.