Human Genome 2nd lupus trial succeeds

By Toni Clarke and Ben Hirschler

BOSTON/LONDON (Reuters) - Human Genome Sciences Inc said its experimental lupus drug Benlysta eased symptoms in more than 43 percent of patients who took it in a clinical trial, paving the way for approval of the first new treatment for the disease in 50 years.

The news sent Human Genome's shares up 33 percent, adding $1 billion to its market value and turning the once unloved company into the hottest biotech story of the year.

Data from a late-stage clinical trial showed patients who took a high dose of the drug, in combination with standard therapies, experienced a significant improvement in symptoms compared with those taking standard treatments in combination with a placebo.

The results met the main goal of the trial, which was the second of two needed for the drug to be considered for approval by the U.S. Food and Drug Administration.

Rockville, Maryland-based Human Genome said it expects to file its marketing application early next year, and could have the drug on the market by the end of 2010.

Lupus, a disease that affects an estimated 5 million people worldwide, causes the immune system to attack the body's own tissue and organs, leading to arthritis, kidney damage, chest pain, fatigue and skin rash, among other problems.

"This is a pivotal moment in lupus research," said Margaret Dowd, president of the Lupus Research Institute, an organization that funds lupus research but did not fund Human Genome's trial.

Analysts expect the drug to generate annual sales of at least $1 billion and potentially much more. Human Genome will split profits from the drug with its larger partner, GlaxoSmithKline Plc.