By Sten Stovall Of DOW JONES NEWSWIRES LONDON -(Dow Jones)- Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline PLC (GSK, GSK.LN) Friday said European drug regulators backed their lupus drug Benlysta, boosting prospects for the first new medicine for treating the debilitating disease in more than 50 years. The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, recommended marketing authorization for Benlysta, also known as belimumab. The European Union's executive Commission will make the final decision within three months and usually follows recommendations by the panel. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. Benlysta won U.S. approval in March and will be co-marketed by Human Genome Sciences Inc. of Rockville, Md. and Glaxo, Britain's biggest drug maker. The medicine is a milestone in the effort to mine data from the human genome to discover and develop new medicines. Analysts expect the drug to reach blockbuster status, with sales eventually topping $1 billion a year. "A positive recommendation from the CHMP is a major milestone in the clinical development program for Benlysta," Moncef Slaoui, head of research and development at Glaxo, said in a statement. Thomas Watkins, President and Chief Executive Officer of Human Genome Sciences said "we and GSK are committed to making Benlysta available in countries worldwide." Benlysta is a bioengineered antibody that blocks a protein called BLyS, or B-lymphocyte stimulator, which is elevated in lupus and other autoimmune diseases and is believed to contribute to production of cells that attack blood vessels and other healthy tissue. Benlysta is one of the most important new drugs in Glaxo's pipeline, and Human Genome Sciences has no products on the market. The drug's success in two large studies, called Bliss, has also generated speculation that Glaxo, or another large drug maker, will try to acquire Human Genome. At 1111 GMT, Glaxo's shares were trading down 0.7% at 1327 pence, with the FTSE-100 up 0.2%. -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall@dowjones.com
