FDA Advisors Support OK of Psoriasis Drug

A medical advisory panel Tuesday recommended Food and Drug Administration approval of Raptiva, bringing Genentech Inc. closer to entering the coveted market for psoriasis drugs.

The expert committee voted 11 to 0 to recommend Raptiva for moderate to severe psoriasis, a chronic skin disease that affects as many as 4 million people in the U.S. The FDA isn’t required to follow its panel’s advice, but it usually does.

The committee acted after the markets closed. Genentech, based in South San Francisco, saw its shares hit a 52-week high Tuesday of $84.73 before closing at $84.55, up $1.03, on the New York Stock Exchange.

Raptiva would be the second biotechnology drug approved for psoriasis -- a market analysts believe will reach $1 billion by 2006. Biogen Inc.’s intravenous medication Amevive entered the market this year.

However, Raptiva’s chief competitor is likely to be Amgen Inc.’s Enbrel, an injectable rheumatoid arthritis drug that currently enjoys significant off-label use by psoriasis patients. Friedman, Billings, Ramsey & Co. estimated that 10% of Enbrel’s sales, which totaled $304 million in the second quarter, are for psoriasis patients.

Amevive, meanwhile, posted sales of $7 million in the second quarter. Analysts said health insurers have required “prior authorization” of prescriptions and that is hurting sales of the Biogen medication.

Friedman Billings analysts Jim Reddoch and David Amsellem in a research note said that Raptiva, a once-weekly injectable, could face a similar insurance hurdle. But they expect Raptiva sales to hit $65 million in 2004, and $364 million by 2007.

Analysts expect Genentech’s drug to be competitive with Enbrel, which costs $13,000 annually.

Data presented by Genentech on Tuesday showed that about 20% of patients significantly improved on Raptiva, and that troubled some panelists.

During the advisory meeting, Maine dermatologist Eileen Rigel worried about the effect of Raptiva on the health-care system and state-funded programs like Medicaid.

“Let’s say one in five patients has success. So we’re talking $75,000 to get one patient clear of psoriasis,” she said. “I have to wonder how many children’s immunizations you can buy for that.”

After the meeting, Hal Barron, Genentech’s vice president of medical affairs, said the quality of life of many patients greatly improved from Raptiva. “There are various degrees of benefit,” he said.

Panelists also were concerned that 19 patients who discontinued Raptiva developed worse cases of psoriasis than they started with. But such incidents were rare; more than 2,500 patients participated in Genentech’s clinical trials.

Genentech is developing Raptiva with Xoma Ltd., a small biotechnology company.