Advisers recommend Human Genome lupus drug

The first new lupus treatment in half a century moved closer to U.S. approval on Tuesday as an advisory panel endorsed a potential blockbuster medicine from Human Genome Sciences Inc.

Benlysta could offer a new option for patients with lupus, a debilitating and potentially fatal autoimmune disease that has proved difficult to treat. Annual global sales are forecast at $2.2 billion by 2014, according to Thomson Reuters.

That would transform unprofitable biotech Human Genome into an industry star.

Benlysta profits will be split with British partner GlaxoSmithKline Plc. Shares of both companies rose in after-hours trading following the positive ruling from the Food and Drug Administration advisers.

The FDA panel voted 13-2 to recommend approval of Benlysta. Supporters said the medicine helped ease symptoms with acceptable risks for a disease with limited options.

"The efficacy is mild, but I think there is a need for a drug even with mild efficacy," said panel member Dr. Lenore Buckley, a professor of internal medicine and pediatrics at Virginia Commonwealth University.

The FDA usually follows panel recommendations when deciding whether to approve new medicines. A final FDA ruling is due by December 9.

"It was a huge victory for the company (Human Genome)," said ISI Group analyst Mark Schoenebaum. "I think the biotech community has another blockbuster drug on its hands."

Trading in shares of Rockville, Md.-based Human Genome had been halted while the advisory panel met on Tuesday. When trading resumed after hours, its shares rose 9.7 percent to $28.40 from Monday's $25.88 close. Glaxo's U.S. shares climbed 2.9 percent to $39.65 in extended trading from Tuesday's regular close at $38.54.

INVESTORS ONCE DESPAIRED

Human Genome shares have soared with hopes for Benlysta. Investors had largely written off the drug after mixed data from an earlier trial. Shares fell below 50 cents a share in March 2009 but jumped later that year after the first encouraging Benlysta data was released.

(For a graphic on how prospects for Benlysta have affected Human Genome shares, click on r.reuters.com/sed35q )

Geoffrey Porges, an analyst with Sanford Bernstein, said the drug's approval was highly likely, although it may not come by December 9 as the companies will need to negotiate label instructions and post-approval studies with the FDA.

"You'll be left with a product with some restrictions on who it will be used for. That will be a hook for the payors to impose some restriction," Porges said. He sees the drug reaching the market by the end of the first quarter of 2011 and forecasts U.S. revenue of $2 billion by 2015.

Benlysta, known generically as belimumab, is given once a month by intravenous infusion. Analysts expect the drug will cost a patient between $15,000 and $30,000 annually, a price in line with biotech medicines for other autoimmune diseases.