Skinning the Competition

Head-to-head trials for drugs can be dangerous for drug companies. If they fail to beat the competition, it becomes that much harder to sell the drug. A comparison to placebo is a much safer route. But winning is sweet, and it can be lucrative.

Motley Fool Income Investor pick Johnson & Johnson (NYSE: JNJ  ) didn't have much choice with its ustekinumab treatment for psoriasis. The market is already pretty crowded, what with Abbott Labs' (NYSE: ABT  ) Humira, Amgen (Nasdaq: AMGN  ) and Wyeth's (NYSE: WYE  ) Enbrel, and its own Remicade, which is sold outside the U.S. by Schering-Plough (NYSE: SGP  ) .

Against this lineup, its best hope at grabbing market share was to go head-to-head against the heavyweight, Enbrel -- which holds 75% of the market by one account -- and avoid being called a second-class drug.

Not only did it go head-to-head, but ustekinumab turned Enbrel around and kicked the pants off it.

The number of patients taking ustekinumab who saw a 75% reduction in their psoriasis was significantly higher at both doses than the number of subjects getting the same level of response from Enbrel. Even better, 36% or 45% of patients, respectively, taking ustekinumab at the two doses almost completely eliminated the psoriasis, compared to just 23% of patients taking Enbrel.

Not only did patients get better results, but they had to inject themselves far fewer times as well. The results from ustekinumab required only two injections, while Enbrel required 24 total shots over the same 12 weeks. With similar side effects, results like the above, and fewer injections, ustekinumab should be a winner.

Johnson & Johnson is now waiting for European and Food and Drug Administration approval for ustekinumab. Early indications are that the FDA liked the drug, although it could have some warning labels attached. Outside experts gave it their unanimous stamp of approval in June, so I think approval is probable. What could stop it, though, are the long-term safety concerns raised previously.

From the looks of the data, ustekinumab should be a hot seller once it's approved. Even if it captures just half of Enbrel's psoriasis patients -- Enbrel also treats rheumatoid arthritis -- ustekinumab would still be well on its way to blockbuster status. And that's good for J&J and investors.

All it needs now is a brand name. May I suggest Beatenbrel?