Another round of questions about Amgen’s anemia drugs

The stakes couldn’t be higher for Amgen this week, as it prepares for yet another FDA hearing on Thursday related to anemia drugs Aranesp and Epogen. The two drugs, as well as one sold by Johnson & Johnson subsidiary Ortho Biotech under a license from Amgen, have spent the past year under fire from the scientific and medical communities, and the questioning doesn’t seem likely to stop any time soon.

The drugs are known as erythropoiesis-stimulating agents; they are bioengineered proteins that stimulate red-blood cell production in cancer patients taking chemotherapy or people with chronic kidney disease. (Both classes of patients commonly experience anemia.) And they are blockbuster products, prescribed to some 4 million people since they’ve been on the market and generating a combined $9 billion for Amgen and J&J in 2007.

Problem is, numerous studies published over the last 18 months have questioned the safety of the drugs, especially when used at high doses. Those studies have suggested that Aranesp, Epogen, and Procrit (the Ortho Biotech version of the drug) increase the risk of heart attack, stroke, and death, and even possibly the more rapid growth of tumors in cancer patients. Not good.

Amgen and Ortho Biotech revised the labels on the drugs in 2007 to reflect these risks, but since then, more studies have come out underlining the drugs’ dangers. And so the FDA advisory committee that specializes in cancer drugs has called another meeting to decide their fate, at least in relation to chemotherapy-induced anemia. Several analysts told Bloomberg they expect the FDA to place further restrictions on the drugs, with a slim possibility that they’ll recommend Aranesp and Procrit not be prescribed for cancer patients at all.

Although any bad news coming out of the Thursday meeting will hurt both companies, it would be far more devastating to Amgen, which depends on Aranesp and Epogen for more than $6 billion in sales, about 40% of total revenue. (J&J is obviously far more diversified but still gets about 5% of its revenue from sales of Procrit.)

Amgen has already gone through a round of lay-offs and restructuring in response to lower sales of the drugs, and the company’s stock price has suffered mightily. Both employees and investors will no doubt be paying attention to what happens Thursday. Stay tuned.