Shares of biopharmaceutical company Human Genome Sciences, Inc. (HGSI) surged nearly 11% on Tuesday after it announced that an advisory panel has recommended to the U.S. Food and Drug Administration for the approval of Benlsyta or belimumab for the treatment of autoantibody-positive patients with active systemic lupus erythematosus.
Benlysta, an investigational human monoclonal antibody drug, is being developed by Human Genome and British drug company GlaxoSmithKline (GSK, GSK.L) under a co-development and commercialization agreement entered into in 2006.The deal called for the two companies to share equally the phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.
Rockville, Maryland-based Human Genome noted that the FDA Arthritis Advisory Committee voted 13 to 2 to recommend that the FDA approve Benlysta. The FDA generally considers the committee's recommendations while approving a drug, but it is not bound by the panels views.
The FDA has assigned Benlysta a Prescription Drug User Fee Act target date of December 9, 2010. If approved on December 9, the drug is reportedly expected to be available in the first quarter of 2011.
Benlysta would be the first Lupus treatment approved since 1958. Lupus is an incurable condition that causes the immune system to attack healthy cells, affecting about 5 million people worldwide.
lupus is a chronic, life-threatening autoimmune disease, with symptoms of extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.
Belimumab, an investigational human monoclonal antibody drug, specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BlyS. Discovered by Human Genome, BlyS is a naturally occurring protein required for the survival and maturation of B-lymphocyte cells into plasma B cells, which produce antibodies, the body's first line of defense against infection.
HGSI closed Tuesday's regular trading session at $25.88, unchanged on a volume of 1.63 million shares, lower than the three-month average volume of 3.22 million shares. However, the stock surged $2.72 or 10.51% to $28.60 in after-hours trading.
GSK closed at $34.54, down $0.69 or 1.76% on a volume of 3.99 million shares, higher than the three-month average volume of 2.03 million shares. However, the stock added $0.91 or 2.36% to $39.45 in after-hours trading.
GSK.L closed on the London Stock Exchange at 1,213.50 pence, down 22.00 pence or 1.78% on a volume of 7.13 million shares.
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