Amgen Gets FDA’s OK for Arthritis Drug Kineret
The government Wednesday approved Amgen Inc.’s treatment for rheumatoid arthritis, the firm’s first entry in a $6.9-billion market.
Kineret is not expected to be a huge seller, but it marks Amgen’s diversification into a category of drugs that suppress the immune system. The Thousand Oaks-based company is experimenting with at least two other compounds that might be useful against rheumatoid arthritis and other diseases, such as asthma. Amgen, which owes its success to drugs that spur blood cell production, is entering a race for new compounds that is well underway. Immunex Corp. and Johnson & Johnson are testing their strong-selling rheumatoid arthritis drugs for other diseases. J&J;’s Remicade has been approved for Crohn’s disease, which affects the bowel. Abbott Laboratories plans to seek approval for an experimental rheumatoid arthritis drug next year.
The Food and Drug Administration approved Kineret for use in patients whose symptoms aren’t relieved by traditional rheumatoid arthritis treatments, such as methotrexate. But analysts don’t think Kineret will unseat Immunex’s Enbrel or Remicade as preferred second-line choices. Those two medications helped 50% to 60% of patients in clinical studies, whereas Kineret helped just 38%.
“I think Kineret will come in at the back of the arsenal, at least initially,” said Dr. Eric Ruderman, an assistant professor at Northwestern University Medical School in Chicago, who participated in clinical trials of all three drugs.
Amgen is portraying Kineret as an equal option to Enbrel or Remicade. But it has priced Kineret at a discount to the two medications, an unusual step that signals the company is well aware it faces an uphill battle. Kevin Young, the Amgen executive who runs the company’s Kineret business, said the new drug will cost $924 monthly, or about $11,000 annually. Enbrel and Remicade cost about $12,000 annually.
But Immunex said Kineret poses no threat to Enbrel, which is expected to post sales of $750million this year. Dr. Dan Burge, vice president of clinical research, called Kineret “an agent to use on the small percentage of patients who need another alternative.”
Kineret must be taken daily by self-injection--a disadvantage over Enbrel, which is self-injected every third day, and Remicade, administered by infusion every eight weeks. Amgen hopes to make daily dosing easy by giving patients an easy-to-hold injection device that hides the needle from view.
Analysts expect respectable sales from Kineret. Fabria Ghodsian, an analyst with Roth Capital Partners in Los Angeles, said Kineret should generate sales of $113million next year. She expects sales of Immunex’s Enbrel to hit $1.3billion in 2002, up from $750million this year.
Ghodsian said Kineret may benefit from a temporary shortage of manufacturing capacity, which is keeping Immunex from filling orders for the Enbrel. But that opportunity is closing for Amgen; Immunex expects to open a plant in Rhode Island next year.
Kineret is the first drug to block a protein called interleukin-1, which plays a role in the joint inflammation of rheumatoid arthritis. Enbrel and Remicade block another protein that shares responsibility for inflammation in rheumatoid arthritis, the tumor necrosis factor. A so-called TNF blocker is among the drugs under study at Amgen.
Amgen’s shares closed at $57.33 down 66 cents, in Nasdaq trading.
