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FDA OKs Enbrel to treat psoriasis; Amgen sees potential for a huge market

By Luke Timmerman
Seattle Times business reporter

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The Food and Drug Administration yesterday approved Enbrel as a treatment for moderate to severe psoriasis, a decision that offers hope to thousands of patients with the painful skin disease and clears the way for the drug to tap another potential billion-dollar market.

It's anyone's guess how many patients will be willing to pay $1,000 a month for the drug to clear up patches of flaky, itchy skin.

But Amgen, the biotech giant that bought Seattle-based Immunex to acquire the drug, is betting that up to 1 million patients would demand Enbrel. Health insurers have begun to pay for it in experimental use in psoriasis.

The FDA approval is the fifth for Enbrel since it was initially approved in November 1998.

The drug racked up $1.3 billion in sales for Amgen last year for more than 100,000 patients with rheumatoid arthritis, ankylosing spondylitis (an inflammatory disease of the spine) and psoriatic arthritis, a combination of rheumatoid arthritis and psoriasis.

Enbrel Maker: Amgen, co-marketed by Wyeth First FDA approved: November 1998 Cost: $1,000 per month, per patient Diseases approved by the FDA to treat: Rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (inflammation of the spine), moderate to severe psoriasis Number of patients taking it: 130,000 Estimated number of patients with moderate to severe psoriasis in U.S.: 1.5 million 2003 sales: $1.3 billion Source: Amgen, National Psoriasis Foundation

The drug can be used to treat all those diseases because they have common biology: They all stem from the body's production of excess inflammatory molecules, which Enbrel soaks up and neutralizes.

Amgen thinks it can reach $1.6 billion to $1.8 billion in Enbrel sales this year, partly because of the new psoriasis patients.

The company has said the new use could drive sales to $3 billion in 2005, making Enbrel one of the best-selling pharmaceuticals ever.

The FDA's long-expected decision was based partly on a clinical trial in more than 650 psoriasis patients that showed half saw at least 75 percent of their skin lesions disappear after three months. After six months, six out of 10 patients saw the same improvement. Side effects were mild and included injection-site reactions, dizziness and sore throat.

That combination of safety and effectiveness is unusual. Traditionally medication for psoriasis has had side effects or discomfort — topical creams, exposure to light, or steroids and other drugs that blunt the immune system.

Enbrel doesn't have the market to itself among the new generation of biotech drugs. Amevive, from Biogen, was approved in January 2003, but its rate of effectiveness is lower than Enbrel. It recorded $13 million in sales in the first quarter this year.

Raptiva, from Xoma and Genentech, was approved in October. It's effective for fewer people and had $6.3 million in sales for the first quarter. Another rival, Humira from Abbott Laboratories, has been effective in clinical trials, but it could be a couple years away from the market in psoriasis.

Laura Hamill, an Amgen vice president, said Enbrel can become the dominant drug in psoriasis. Based largely on presentations of the Enbrel results at dermatology meetings, she said the drug was prescribed before FDA approval by about 3,600 dermatologists.

But with the FDA's blessing, Hamill said Amgen can turn marketers loose on 8,000 dermatologists, and it also plans to buy television ads.

The psoriasis approval will not change the lives of Amgen's 850 employees in Seattle and Bothell, but it will have sentimental value.

"It's always nice to see your baby born," Hamill said.

Art Wassmer, a Bellevue psychologist who has had severe psoriasis for 35 years, said his hands and arms were once so discolored, flaky and scaly, that he avoided parties and has tried to give clerks exact change so he doesn't have to hold out his hands in the open.

After taking Enbrel, his lesions have almost completely vanished.

"It's expensive, and it's worth every penny," Wassmer said. "It really sounds almost religious, and I don't like to say that because I'm not religious, but it really is a blessing."

Luke Timmerman: 206-515-5644 or ltimmerman@seattletimes.com

Copyright © 2004 The Seattle Times Company

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