* 43.2 pct of patients respond vs 33.8 pct for placebo * Paves way for approval of first new lupus drug in 50 yrs * Companies plan to file Benlysta in first quarter 2010 * Human Genome shares up 18 percent in Germany * Glaxo shares down 1.5 percent (Adds analyst comment, share prices) By Toni Clarke BOSTON, Nov 2 (Reuters) - Human Genome Sciences Inc <HGSI.O> 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 sceptical, given the previously poor track record of new lupus treatments. But to win approval from regulators, Human Genome and its partner GlaxoSmithKline Plc <GSK.L> 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 <HGSI.F> jumped 18 percent in early trading in Germany, while Glaxo stock was down 1.5 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. Tammy Utset, an associate professor of medicine at the University of Chicago, who was involved with the clinical studies said the results were "spectacular news" and should encourage further interest in drug development for lupus. The trial also measured patients who took a low dose of the drug. The results of that part of the trial were not statistically significant. Serious side effects were reported in 26.8 percent of patients taking Benlysta, compared with 24 percent of patients taking a placebo. The trial, known as BLISS-76, is the second of two required by the U.S. Food and Drug Administration in order for the drug to be considered for approval. The results follow similarly successful data from a trial known as BLISS-52 that were released in July. That trial showed that 57.6 percent of patients taking a high dose of Benlysta in combination with standard of care showed an improvement in symptoms compared with 43.6 percent of patients taking standard of care plus a placebo. Lupus affects about 1.5 million people in the United States and 5 million worldwide, according to the Lupus Foundation of America. (Additional reporting by Ben Hirschler in London; Editing by Hans Peters and Jon Loades-Carter)
Ukraine's Prime Minister Yulia Tymoshenko (R) holds a packet with the antiviral drug Tamiflu, used to treat H1N1 virus, as she talks to journalists at Kiev's Boryspil airport, November 2, 2009. ...
