Human Genome Sciences lupus drug met study goal

WASHINGTON - Biotech drugmaker Human Genome Sciences reported positive results Monday for its experimental lupus drug, confounding analyst expectations and potentially clearing the way for the first new treatment against the inflammatory disease in a half century.

The late-stage results come after nearly a decade of research and development by the company aimed at relieving symptoms of lupus, a difficult-to-treat ailment in which the body attacks its own tissue and organs.

Patients who took the injectable drug Benlysta plus a standard treatment for one year had reduced symptoms — including pain, rashes and infections — compared with patients taking standard treatment plus placebo. The study involved more than 860 patients in Asia, South America and Eastern Europe.

The results sent Human Genome Sciences stock surging 277 percent Monday to close at $12.51, more than three times Friday's closing price of $3.32. The stock has ranged from 45 cents to $8 over the past year.

"We're delighted," said Executive Vice President Dr. David Stump, in a preliminary interview Friday. "It's a disease that hasn't had a new approved drug in 50 years, so it's a first in many ways."

The Rockville, Md., company said 51.7 percent of patients taking 1 mg of Benlysta for every kilogram of body weight experienced a significant improvement. Of patients who took a larger dose, 10 mg per kilogram, 57.6 percent had a significant improvement. That compared with 43.6 percent for the placebo patients.

Company executives said they are optimistic a second study conducted in North America will confirm the findings in November, clearing the way for a submission to the Food and Drug Administration in 2010.

Wall Street analysts had repeatedly downplayed the drug's chances for success.

Last month Lazard Capital Markets analyst Terence Flynn downgraded shares to "Sell" from "Hold" and issued a $1 price target.

"We continue to believe that the probability that this drug succeeds is extremely low," Flynn said, citing the design of the study and what he called "unimpressive" effectiveness in prior studies.

On Monday Lazard Capital switched the rating back to "Hold."

"The skepticism is perhaps understandable," said Human Genome Sciences CEO Tom Watkins. "But I hope and expect that Wall Street will share our enthusiasm here, that this is great progress for lupus patients and for the company."

A 2005 study of the company's drug — a synthetic version of a human protein — failed to meet researchers' preset goal. But Human Genome found that the drug helped block the antibodies that cause lupus symptoms in a subset of roughly three-fourths of patients. The company estimates there are 1.5 million patients in the U.S. who could benefit from the drug and 5 million worldwide.

Lupus occurs more frequently in women than men, though it's unclear why. The disease is marked by skin rashes, joint pain and swelling, inflammation of the kidneys and the fibrous tissue surrounding the heart, as well as other problems.

Executives said Benlysta could be available as early as late 2010, assuming it gets an accelerated review from the FDA. The agency gives priority to drugs that present major medical advances.

Britain's GlaxoSmithKline, the world's second largest drugmaker, has agreed to co-market the drug, splitting the profits with Human Genome.

The drug's chemical name is belimumab, and it was previously developed under the name LymphoStat-B.

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AP Business Writer Marley Seaman contributed to this report from New York.

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