Glaxo, Human Genome Say Lupus Drug Worked 16 Weeks Into Study
The 865-patient study, known as Bliss-52, found Benlysta was more effective at easing pain, hair loss and skin rash than a placebo, London-based Glaxo and Rockville, Maryland-based Human Genome said in July, when they announced the initial results of the trial.
A full presentation of the data today showed that the improvement was statistically significant and sustained for both the higher dose and lower dose of the drug from week 24 and week 28, respectively, for the duration of the 52-week test. The rate of improvement was “generally consistent” across different groups of patients, according to the data presented today at the Scientific Meeting of the American College of Rheumatology in Philadelphia.
“The main thing were looking for is if the improvement versus placebo was sustained during the year,” Matrix Corporate Capital analyst Navid Malik said in an interview before the announcement. “How fast does this drug kick in?”
The initial findings triggered Human Genome Sciences shares to more than triple on July 20 to their greatest increase since the stock began trading in 1993. The positive overview of the data surprised analysts, who cited disappointing earlier clinical trials and a history of failures for treatments of lupus, which causes the immune system to attack healthy cells.
Peak Sales
Benlysta, known chemically as belimumab, may become the first new drug in 50 years for the autoimmune disease and bring in annual peak sales of $3.5 billion by 2015, according to Panmure Gordon analyst Savvas Neophytou.
Patients in the study received one of two doses of the drug or a placebo. At the lower dose, 51.4 percent of patients showed improved symptoms compared with 43.6 percent who took the placebo, Human Genome said in July. At a higher dose, 57.6 percent had improved symptoms, according to the company.
If Benlysta succeeds in its next trial, Bliss-76, the companies plan to apply for approval to sell it in the U.S., Europe and other countries in the first half of 2010.
The drug may fetch $15,000 to $20,000 a year per patient, based on the history of rheumatoid arthritis and multiple sclerosis treatments, Barry Labinger, Human Genomes chief commercial officer, said on July 20.
Human Genome is conducting Bliss-76, a 76-week trial of Benlysta. Both studies are being conducted under a “special protocol assessment” from the U.S. Food and Drug Administration, which allows a drugmaker to work with the agency to design a late-stage clinical trial with scientific goals that, if met, would be sufficient for marketing approval.
Results of the 76-week trial are expected on Nov. 2.