Amgen Seeks to Market Drug for Psoriasis
Amgen Inc. said Tuesday that it has asked U.S. regulators to approve the sale of its rheumatoid arthritis drug, Enbrel, to treat the skin disorder psoriasis.
Amgen, based in Thousand Oaks, said it has applied to the Food and Drug Administration to market Enbrel for moderate to severe plaque psoriasis. The inflammatory condition, marked by red, scaly patches of skin, affects about 7 million people in the United States, including about 1.5 million with more severe forms of the disease.
The injected drug has been sold for several years, in partnership with Wyeth, as a treatment for the painful joint disorder rheumatoid arthritis and psoriatic arthritis. Enbrel sales were $802 million last year, and Amgen has projected 2003 sales of $1.2 billion to $1.4 billion.
Mike King, a Banc of America Securities analyst, said the psoriasis indication is “a several-hundred-million-dollar market opportunity” for Enbrel. He said about 8% of prescriptions for the drug are being written by dermatologists.
Pivotal-stage trial results showed that three months of treatment with high doses of the drug, which blocks a protein called tumor necrosis factor, improved symptoms by at least 75% in 49% of patients. A lower dose improved symptoms by 75% in 34% of patients.
King said Enbrel is unlikely to be used to a great extent at the higher dose, largely because of the cost issue. Enbrel is approved for rheumatoid arthritis at the lower dose used in the psoriasis trial, a regimen that costs $10,000 to $12,000 a year.
An Amgen spokeswoman said the company would comment further after it reports quarterly results July 22.
Drug companies are eager to crack the psoriasis market, which analysts estimate could be worth $5 billion. Regulators have approved Amevive, a new drug from Biogen Inc., and other drugs are being developed by Genentech Inc. and its partner Xoma Ltd.; Johnson & Johnson; and Abbott Laboratories Inc.
Until recently, the only systemic treatments for the skin disorder were immunosuppressant drugs such as methotrexate, but they can damage organs such as the heart or liver.
Amevive is designed to work by suppressing an immunity-boosting cell that plays a central role in psoriasis, while Enbrel works by blocking a protein that causes inflammation.
Amgen said Enbrel was generally well-tolerated in the psoriasis studies, citing injection-site reactions as the most frequent adverse side effect.
Amgen rose $1.08 to $69.99 on Nasdaq, a 52-week high. Wyeth fell 29 cents to $46.08 on the New York Stock Exchange.
