Human Genome Sciences, GlaxoSmithKline report positive results in 2nd lupus drug study

Human Genome reports positive data on lupus drug

NEW YORK — Human Genome Sciences and GlaxoSmithKline said Monday their experimental lupus treatment passed another key goal on its path to potentially becoming the first new drug for the disease in decades.

Shares of Human Genome Sciences soared more than 35 percent on the report.

Wall Street and researchers anticipated study data from Bliss-76, hoping it would confirm positive results from a prior late-stage study. Benlysta is aimed at suppressing the immune system’s response to lupus, which is an inflammatory disease prompting the body to attack its own tissue and organs.

The anticipated study data, from a clinical program called Bliss-76, showed a 10-milligram dose of Benlysta, plus therapy with steroids, prompted an improvement in 43 percent of patients, compared with an improvement in only 33 percent of patients on the placebo end of the study.

“The Bliss-76 results confirm our view that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus,” said Human Genome President and CEO H. Thomas Watkins, in a statement. “We take great pride in the innovation and scientific rigor that has made it possible to bring Benlysta to this point.

Human Genome of Rockville, Md., and GlaxoSmithKline, based in the U.K., plan to seek Food and Drug Administration regulatory approval in the first half of 2010.

Bliss-76 involved 865 patients and took place over 52 weeks. It is the second late-stage study on the potential lupus treatment to meet key goals. Last month, the company reported similar positive results from Bliss-52, which involved more than 860 patients in Asia, South America and Eastern Europe.

Lupus is an inflammatory disease in which the body attacks its own tissue and organs.

Leerink Swann Research analyst Joseph P. Schwartz reaffirmed a “Outperform” rating for Human Genome, saying he expects Benlysta to gain regulatory approval and then reach the market by the second half of 2010. He boosted his fair value outlook for the stock to $40 from $30. He expects the company to present full results from Bliss-76 in the spring of 2010 at a medical conference.

Shares of Human Genome Sciences rose $6.59, or 35.3 percent, to $25.28 in Monday trading. Earlier the stock traded at $26.21, its highest level since February 2002.

U.S.-listed shares of Glaxo fell 45 cents to $40.71.