* Advisory panel recommends Benlysta approval
* FDA usually follows panel recommendations
* Agency decision expected by Dec. 9 but could slip
* Annual global sales forecast at $2.2 billion by 2014
* Shares of partner Glaxo rise afterhours on NYSE (Adds analyst comment, Glaxo share movement)
By Lisa Richwine
ADELPHI, Md., Nov 16 (Reuters) - A highly anticipated lupus treatment from Human Genome Sciences Inc HGSI.O moved closer to the U.S. market on Tuesday with an endorsement from a government advisory panel.
Benlysta could become the first medicine in a half-century to win approval for fighting the debilitating and potentially fatal autoimmune disease. 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. [ID:nN05192427]
A Food and Drug Administration advisory panel voted 13-2 to recommend approval of Benlysta. Supporters said the medicine helped ease symptoms with acceptable risks.
“The efficacy is mild, but I think there is a need for 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 Dec. 9.
“It was a huge victory for the company,” said ISI Group analyst Mark Schoenebaum. “I think the biotech community has another blockbuster drug on its hands.”
Trading in Human Genome shares had been halted while the panel met on Tuesday, but Glaxo’s shares on the New York Stock Exchange rose 3.3 percent to $39.80 in afterhours trade following the advisory panel vote.
(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 approval was highly likely although it may not come by Dec. 9 as the companies will need to negotiate label instructions and post-approval studies.
“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.
Human Genome argued the intravenous drug was an important advance for fighting lupus, a disease that causes the immune system to attack the body’s own tissue and organs. That can lead to arthritis, kidney damage, chest pain, fatigue, skin rash and other problems. Organ damage can be fatal, and current treatments have severe side effects.
FDA reviewers, however, suggested Benlysta might have only a modest effect on lupus symptoms and might raise the risk of death, infection, or psychiatric problems including suicide. Two patients treated with Benlysta during clinical trials killed themselves and there were no suicides with a placebo. (Additional reporting by Bill Berkrot in New York and Karey Wutkowski in Washington; Editing by Maureen Bavdek, Lisa Von Ahn and Tim Dobbyn)