Business and Finance

Human Genome Sciences Inc said on Monday its experimental lupus drug Benlysta was successful in a second large clinical trial, paving the way for approval of the first new treatment for the disease in 50 years.

Results of the late-stage trial showed patients given a high dose of the drug, Benlysta, experienced a statistically significant improvement in symptoms compared with those taking a placebo.

Hopes for Benlysta have been growing since July, when it was shown to work in a first clinical trial to the surprise of many experts who had been skeptical, given the previously poor track record of new lupus treatments.

But to win approval from regulators, Human Genome and its partner GlaxoSmithKline Plc needed to have a second successful study result.

“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 Science’s trial.

“It demonstrates the power of innovative science to drive discovery and achieve solid clinical results in the complex autoimmune disease of lupus.”

Panmure Gordon analyst Savvas Neophytou said the companies had struck gold with the latest results and predicted that registration of the drug would now be “routine,” adding the new blockbuster could be on the market by mid-2010.

Shares in Human Genome jumped 18 percent in early trading in Germany, while Glaxo stock was down 1 easy online payday loans.5 percent.

Glaxo and Human Genome, which will share profits from Benlysta on a 50-50 basis, said they planned to file for approval in the first quarter of next year.

$3 BILLION POTENTIAL

Assuming Benlysta now gets approved, Human Genome and Glaxo will have a drug worth as much as $3 billion a year, according to some analysts — nice for Glaxo, the world’s No. 2 drugmaker, and transformational for Human Genome, a small Rockville, Maryland-based company that has struggled in the shadows for years.

Data from a composite of three measures in the latest trial showed that after 52 weeks, 43.2 percent of patients taking 10 milligrams of Benlysta in combination with standard of care achieved an improvement in symptoms, with no significant worsening of disease in individual organs.

That compared to a figure of 33.8 percent for patients taking Benlysta in combination with a placebo.

The result met the main goal of the clinical trial.

Lupus causes the immune system to attack the body’s own tissue and organs, including the joints, kidneys, heart, lungs, brain, blood and skin. It can cause arthritis, kidney damage, chest pain and skin rash, among other disorders. 

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