Rockville-based Human Genome Sciences announced Monday that its experimental lupus drug has completed its final round of testing at a higher dose and will be headed to the Food and Drug Administration for approval.
The latest round of studies on the experimental drug Benlysta showed that a sufficient number of lupus patients given a higher dosage of the drug showed improvement after a year, which enabled the drug to meet its target. A lower dosage of the drug did not meet that target.
The next step is to submit the drug to the FDA. If approved, Benlysta could be on the market in late 2010.
“We believe that likelihood of approval is high and that commercial potential is substantial,” Barclays Capital analyst Jim Birchenough wrote in a note to investors.
Many industry analysts and lupus experts have questioned whether a new medication for treating the disease would ever come; it has been more than 50 years since a lupus drug has been approved.
HGS would share any profit from the drug with pharmaceutical giant GlaxoSmithKline, a partner that contributed to the drug’s development and testing expenses.
“We’ve got a good chance to redefine the standard of care for patients living with lupus,” said H. Thomas Watkins, chief executive of HGS. Lupus, an autoimmune disease, manifests itself differently in every patient, making the development of treatments particularly difficult.
Before July 20, the day HGS revealed that its experimental drug had performed well in a near-final round of testing, the company’s shares had been trading at under $3. Ever since, the company’s stock has been rising. Monday’s announcement sent shares surging again to over $25 in morning trading.
The stock also has risen in recent months as a result of periodic rumors that GlaxoSmithKline will acquire HGS.
Watkins said his company is “no small start-up” and, therefore, doesn’t need to be bought out by a larger firm in order to bring its lupus drug to the market. “HGS has the wherewithal to fully realize this opportunity as an independent company,” he said. “Our business plans call for us to go forward as an independent company.”
Benlysta attempts to control the actions of a protein that becomes overactive in lupus patients. In test results, 43.2 percent of patients responded to the drug at the higher dose and 40.6 percent responded at the lower dose. That compares with a placebo response rate of 33.8 percent.
Analyst Joseph P. Schwartz, of Leerink Swann, reiterated his “outperform” rating on HGS stock, and wrote that the test results “provide us with increased confidence in Benlysta’s approvability and uptake.”
The Lupus Foundation of America estimates that about 1.5 million Americans have some form of the disease, which has typically been treated with chemotherapy and steroids.
“Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease,” Sandra C. Raymond, the organization’s president and chief executive, said in a statement. “We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires.”