Human Genome Sciences, Inc. (Nasdaq: HGSI) shares rallied to a 52-week high of $26.21, and added $1 billion to its market value after the company announced favorable results from the second phase of clinical trials for its lupus treatment, Benlysta on Monday.
Rockville, Maryland-based Human Genome said it expects to file its marketing application for Benlysta, early next year, and could have the drug on the market by the end of 2010. If approved, Benlysta will be the first new lupus treatment on the market in more than 50 years.
“The lupus community has waited for decades for one, positive phase III trial of an investigative drug developed for lupus,” said Dr. Joan T. Merrill, a lupus expert at the Oklahoma Medical Research Foundation and an investigator in the trial, in a statement issued by Human Genome Sciences and its development partner, GlaxoSmithKline. “Now we have two.”
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 therapies achieved an improvement in symptoms, with no significant worsening of the disease in individual organs.
Only 33.8 percent of patients receiving the placebo and standard care had noticeable improvement. Serious side effects were reported in 26.8 percent of patients taking Benlysta, compared with 24 percent of patients taking a placebo.
Lupus, which affects approximately 5 million people worldwide, is an autoimmune disorder in which the body’s own defense system against pathogens turns on the body and begins attacking healthy tissues. The symptoms can include, but are not limited to, rashes, arthritis, mouth sores, and kidney damage. Historically, it has been difficult to demonstrate in clinical trials the effectiveness of potential lupus drug candidates as the symptoms vary greatly from one individual to another.
Benlysta, which is known generically as belimumab is given once a month by IV infusion, and works by blocking a protein that stimulates B cells that are produced by the immune system. Human Genome, a trailblazer in studying genomics, first discovered the gene for that protein. The discovery would make Benlysta one of the first drugs to arise from genomics, if the drug is approved.
The company has not yet nailed down a price for the drug, but biologic drugs that treat rheumatoid arthritis and multiple sclerosis, which are also autoimmune disorders, range between $15,000 and $30,000 per patient per year, according to Barry Labinger, Human Genome’s chief commercial officer.
Shares of Human Genome Sciences, which traded at $3.32 the day before the positive first trial data was announced in July, closed the following day at $18.69 per share.
Analysts expect the drug to generate annual sales of at least $1 billion and potentially much more. Human Genome will split profits from the drug with its larger partner, GlaxoSmithKline Plc (NYSE: GSK).