Benlysta Shatters Market Expectations and Upholds Cutting Edge Information's Forecast


RESEARCH TRIANGLE PARK, NC--(Marketwire - July 23, 2009) - Benlysta, an experimental treatment for lupus, recently surprised many industry observers with positive clinical news.

On Monday, shares for Human Genome Sciences jumped 277%, and its partner GlaxoSmithKline saw shares rise 4% on the results of a Benlysta Phase 3 study. While positive trial data is newsworthy in itself, one main factor has made Benlysta a surprise: many analysts expected it to fail.

For the first time since systemic lupus erythematosus was identified a century ago, patients are optimistic about treatment. In lupus's history, no drug has been successfully developed to treat the disease, which attacks 5 million people worldwide. In fact, it has been five decades since the FDA has approved any drug for use in patients with lupus. Now Benlysta looks to become the first, regardless of how a second Phase 3 trial turns out.

Benlysta inhibits the biological activity of B-lymphocyte stimulator (BLyS). Elevated BLyS levels contribute to the production of autoantibodies that attack the body's healthy tissues in many B-cell mediated autoimmune diseases, including lupus and rheumatoid arthritis. This science caused pharmaceutical business intelligence firm Cutting Edge Information to disregard other analysts' position and to state in its report "Autoimmune Market Forecast to 2014" that Benlysta had a good chance of overcoming the difficulties most lupus compounds have faced in development.

"After examining the published mechanism of action and researching what leading immunologists had to say, we felt that Benlysta had a strong chance of success," said Shaylyn Pike, research analyst at Cutting Edge Information and lead author of the report. "Despite the fact that the good news surprised some, it's important to remember that Wall Street valuations do not determine the success of a compound. The only thing that matters is its ability to treat targeted conditions."

According to the report, Human Genome Sciences and GlaxoSmithKline remain on track to launch Benlysta at the end of 2010. Already, the compound looks to earn more than $500 million in 2014 sales. Should Benlysta's second Phase 3 trial for systemic lupus erythematosus or its Phase 2 trial in rheumatoid arthritis return positive results, the compound could reap blockbuster sales.

Contact Information: CONTACT: Shaylyn Pike