Human Genome reports additional lupus drug data

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Human Genome reports additional lupus drug data

Tue Oct 20, 2009
Company provides more details about BLISS-52 trial
Details reinforce top-line data released in July  Company expects to announce next trial in November
Human Genome Sciences Inc
(HGSI.O) reported data on Tuesday showing its experimental lupus drug works faster than previously thought and significantly reduced the risk of disease flare-ups. The company, which released its findings at the annual American College of Rheumatology meeting in Philadelphia, saidthe drug, Benlysta, reduced the risk of disease flare-ups by 24 percent, and of severe flares by 43 percent compared with a placebo. Human Genome's shares have soared more than 500 percent since July, when it released unexpectedly positive data from a52-week, 865-patient trial known as BLISS-52. Initial data showed that 57.6 percent of patients taking the higher dose --10 milligrams per kilogram of body weight -- of Benlysta for a year experienced an improvement in symptoms, compared with 43.6 percent who took a placebo.

If approved, Benlysta, known chemically as blimumab, will be the first new drug in 50 years to treat lupus, a complex disorder that causes the immune system to attack the body's own
tissue and organs. Symptoms include achy joints, fever, arthritis, kidney damage, chest pains and skin rash. A detailed analysis of the BLISS-52 trial showed patientswho took the higher of two tested doses of Benlysta, together with current standard of care, went for an average of 119 days before experiencing a flare-up, compared with an average of 84 days for the group that took the placebo plus standard care.

The data also showed that patients had a statistically significant reduction in fatigue four to eight weeks into treatment. "These data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points," said David Stump, Human Genome'sexecutive vice president in charge of research and development, in a statement. Serious infections were reported in 5.9 percent of patients in the placebo group and 6.1 percent of those taking Benlysta, which is administered by infusion, the company said. On Nov. 2, Human Genome expects to announce initial results from a second 52-week trial of Benlysta known as BLISS-76. If results from the second trial mirror those of the first, the company would file for approval of the drug with U.S. regulators in early 2010. Analysts predict it could generate billions of dollars in annual sales. The company has said it expects the drug to costpatients about $20,000 a year. Human Genome is developing the drug together with GlaxoSmithKline Plc (GSK.L) and will split revenue from the drug once it is approved for sale.
SOURCE: PRESS RELEASE