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HGS to Test Lupus Drug as MS Treatment

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By Kendra Marr
Washington Post Staff Writer
Thursday, May 29, 2008

Human Genome Sciences told analysts yesterday that it was moving forward on several biotechnology drugs and that it planned to begin testing its experimental lupus drug as a treatment for multiple sclerosis.

"One of the knocks on this company is that they have not had anything make it past the goal line," said Christopher J. Raymond, a biotechnology analyst with R.W. Baird. "But they are very close with a number of exciting products."

Meeting in New York, the Rockville firm said its lupus treatment, LymphoStat-B, could be effective in treating multiple sclerosis because it inhibits a protein found in high levels in the disease's lesions. As the disease progresses, the levels of these targeted proteins also rise, contributing to the production of cells that turn against the body and attack healthy tissue.

Multiple sclerosis is the first of four autoimmune diseases that HGS and its partner GlaxoSmithKline, a British drugmaker, want to treat using LymphoStat-B. The companies are still working on the details of the trial, said HGS spokesman Jerry Parrott.

In the meantime, the partners plan to continue late-stage trials using LymphoStat-B to help lupus patients. HGS is racing to develop the first new lupus drug in four decades, and executives said they expected to finalize data from the trials by fall 2009 in preparation for seeking Food and Drug Administration approval in early 2010.

"When you talk to patients about their lupus experience, the side effects of treatments are as bad or worse than the disease itself," Barry Labinger, HGS's executive vice president and chief commercial officer, told analysts. "Clearly there is a need for treatment to help patients lead a better quality of life."

HGS shares rose 10 cents yesterday, to $5.91. The stock has not rebounded from the hit it took in January, when news that high doses of its hepatitis C drug called Albuferon caused lung-related side effects prompted the stock price to plunge more than 40 percent.

Since then, HGS has followed the suggestion of an independent drug-monitoring committee and lowered its dosage of Albuferon.

"The data-monitoring committee has remained just as vigilant in the months since they made that decision, and you haven't heard any more news," Parrott said.

Albuferon, which is being developed jointly with Swiss drugmaker Novartis, requires half as many as injections as the hepatitis drug Pegasys, which is on the market and is made by Roche.

HGS is expecting all late-stage data for Albuferon by spring 2009 for filing several marketing applications in different countries by fall 2009.

The company also updated analysts on the status of its anthrax treatment.


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