Rival Psoriasis Drugs Both Come Off Well in a Face-Off

No clear winner emerges in dueling drugs from Biogen and Genentech.
By Adam Feuerstein ,

Genentech

(DNA)

and

Biogen

(BGEN)

came out strongly Thursday in the great psoriasis drug showdown. Each improved its standing, but neither emerged as an obvious choice.

Speaking at the

International Psoriasis Symposium

in San Francisco, Genentech and partner

Xoma

(XOMA) - Get Report

released late-stage test results that showed its drug, Xanelim, was effective in reducing the painful, itchy skin lesions that makes psoriasis such a debilitating disease.

Biogen countered with results for its drug, Amevive, which quelled concerns about potentially dangerous side effects.

Questions Remain for Each

Some questions remain unanswered about both drugs, which could disappoint investors seeking a clear winner. The 7 million psoriasis sufferers worldwide will be much more sanguine, because it appears that a first-of-its-kind crop of truly beneficial drugs is moving much closer to gaining approval from U.S. drug regulators.

Genentech researchers said that in 39% of patients taking Xanelim, psoriasis symptoms were reduced by at least 75%, a level considered to be the "gold standard" by doctors and regulators.

Overall, 61% of patients taking Xanelim found their symptoms reduced by at least 50%. Patients took Xanelim by an injection just under the skin, once a week for 12 weeks, and began showing positive results in as little as two weeks.

The results also seemed to confirm some possible shortcomings of the drug, namely that patients relapse fairly quickly once they stop taking it. Some patients in the study saw their psoriasis symptoms return in two to three months, although the severity of the relapse was not reported. The company is still crunching complete relapse results, but the preliminary findings suggest that patients will have to take Xanelim continuously.

Is Xanelim safe enough for patients to take every week for the rest of their lives? That was one of the important questions left unanswered at Thursday's meeting. Genentech and Xoma discussed only partial results today, which means that additional findings, including important details about safety results, still need to be analyzed before a complete picture of the drug can be reviewed.

Drug Makers Are Addressing Long-Term Safety

Genentech executives say they expect to finish analyzing the Xanelim data in time to file for approval with the

Food and Drug Administration

by the end of the year or the beginning of next year. But at the same time, they concede that the need to prove Xanelim's long-term safety could delay that approval. Some of the answers to that question will come from a current 12-month safety study, which isn't expected to be completed until April at the earliest.

Safety was the topic of the day for Biogen and its drug Amevive. Unlike Xanelim, Amevive works by suppressing, or eliminating certain types of immune system cells, known as T-cells. Observers at the conference were eager to hear whether this "T-cell depletion" could open up patients to increased risk to infection.

The answer appears to be no, according to test results released Thursday. Patients taking Amevive were at no greater risk of infection than patients taking a placebo, and the overall health of the immune system's response was equal in both groups, according to researchers.

Some preliminary results about Amevive's efficacy also were released Thursday, although they will be discussed in greater detail Friday. In a sneak peak, an Amevive researcher said that 33% of patients taking the drug experienced reduced psoriasis symptoms by the gold standard of 75%. Overall, 57% of patients saw a 50% reduction in psoriasis. These patients all took a deep-muscle injection of Amevive once a week for 12 weeks.

That mimics results previously released by Biogen for patients taking Amevive intravenously.

Furthermore, Amevive appears to work a lot longer than rival Xanelim. Patients stayed clear of psoriasis symptoms for an average of 10 months.

Biogen executives have stated previously that they expect to send Amevive to the FDA for approval by the end of the year.

Overall, the findings for both drugs had researchers crowing about the beginning of a new phase in psoriasis treatment.

"The opportunity we have today is for a new class of

drugs that are safe and effective for patients over the long term," says Alice Gottlieb, professor of medicine at the

University of Medicine and Dentistry at New Jersey's Robert Wood Johnson Medical School

and a principal investigator for both drugs. "The current treatments are generally unsafe and are only used intermittently."

Some of Biogen's results were released during Thursday trading, helping push shares up $2.62, or 4%, to $66.80. Genentech and Xoma released results after the market close. Genentech was down 21 cents to $55.57; Xoma was down $1 to $12.24.

Loading ...