J&J skin drug could face slow uptake, analysts say

If approved, ustekinumab would be the first in a new class of drugs to block two proteins in the immune system responsible for regulating inflammation. Johnson & Johnson's Centocor unit is seeking approval of the drug for psoriasis, which is characterized by painful red scales on the skin.

An agency decision is expected by early October. The FDA is not required to follow the advice of the panel, though it often does.

Centocor is attempting to differentiate ustekinumab over existing psoriasis drugs by its infrequent dosing schedule of as few as four injections per year. Existing psoriasis drugs include Centocor's own Remicade, Enbrel from Amgen Inc. and Wyeth, and Humira from Abbott Laboratories.

During Tuesday's FDA panel discussion, a majority of members voted that ustekinumab should be administered only by a doctor rather than by the patient at home, and also recommended a mandatory patient registry following approval to monitor for side effects.

Raymond James analyst Jayson Bedford, who rates J&J a "Buy," said those requirements would likely curtail peak sales potential.

Bedford added that ustekinumab could get an additional boost in September when data from a head-to-head trial against Enbrel is released.

Citigroup Investment Research analyst Matthew J. Dodds said panel members' concerns over cancer risks could limit initial use of ustekinumab until long-term data becomes available. He maintained his "Buy" rating.

Earlier this month, the FDA said it was investigating reports of cancer in children who used drugs in the same class as Remicade, Enbrel and Humira.

On Wednesday, the same FDA panel that debated ustekinumab voted to recommend expanding Enbrel's approved uses to treat children with psoriasis.