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Human Genome reports additional lupus drug data

Tue Oct 20, 2009 1:00am EDT

 * Company provides more details about BLISS-52 trial
 * Details reinforce top-line data released in July
 * Company expects to announce next trial in November
 By Toni Clarke
 BOSTON, Oct 20 (Reuters) - 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, said
the 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 a
52-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. [ID:nN2083796]
 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 patients
who 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's
executive 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 cost
patients 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.
 (Reporting by Toni Clarke, editing by Matthew Lewis)


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