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UPDATE 1-US FDA staff question Human Genome lupus drug data

WASHINGTON, Nov 12 (Reuters) - U.S. drug reviewers questioned the effectiveness of a long-awaited Human Genome Sciences Inc drug for lupus and will ask outside experts about safety issues including suicide. The company's shares slipped 4.1 percent to $25.40 in heavy premarket trading. Food and Drug Administration staff, in documents released on Friday, said they would ask an advisory panel that meets Tuesday if company findings provide strong enough evidence of benefit to justify risks of the drug, Benlysta.

Industry analysts view the drug as a potential blockbuster if approved. "The robustness and the clinical meaning of the efficacy findings warrant discussion," FDA staff wrote in a summary prepared for the panel. Safety issues requiring input include cancers, infections and suicide, the FDA reviewers said. They noted lupus patients are known to have a higher risk of suicides but also said cases were higher with Benlysta than a placebo in clinical studies. Mark Schoenebaum, an analyst with ISI Group, said he still expected the advisory panel to recommend approval of Benlysta. He said there was "nothing surprising" in the FDA review other than the suicide issue. Human Genome will split Benlysta profits with partner GlaxoSmithKline. (Reporting by Lisa Richwine, Editing by Phil Berlowitz) ((lisa.richwine@thomsonreuters.com +1 202 310-5691; Reuters Messaging: lisa.richwine.reuters.com@reuters.net)) Keywords: HUMANGENOME LUPUS/ * FDA reviewers seek panel input on effectiveness, suicide * Consensus sales forecast of $2.2 bln in 2014 * Advisory panel to provide input on Tuesday * Human Genome shrs drop 4 pct; Glaxo shrs down 0.6 pct (Adds analyst comment; updates shares) By Lisa Richwine WASHINGTON, Nov 12 (Reuters) - U.S. drug reviewers questioned if the benefits of a long-awaited Human Genome Sciences Inc lupus drug outweighed concerns about suicides and other possible risks, but analysts said they still expect approval. The company's shares slipped 4 percent in early Nasdaq trading on Friday after the Food and Drug Administration released a preliminary review of the drug, Benlysta, on Friday. If approved, Benlysta would become the first medicine cleared for fighting the autoimmune disease in a half-century, and blockbuster sales are expected. Human Genome will split Benlysta profits with partner GlaxoSmithKline. Consensus forecasts from Thomson Reuters predict annual sales of $2.2 billion globally in 2014. FDA staff said they would ask an advisory panel, which is scheduled to meet on Tuesday, if company findings provide strong enough evidence of benefit to justify potential risks. "The robustness and the clinical meaning of the efficacy findings warrant discussion," FDA staff wrote in a summary prepared for the panel. Safety issues to be discussed include cancers, infections and suicide, the FDA reviewers said. They noted lupus patients are known to have a higher risk of suicides but also said cases were higher with Benlysta than a placebo in clinical studies. Mark Schoenebaum, an analyst with ISI Group, said he still expects the advisory panel to recommend approval of Benlysta. He said there was "nothing surprising" in the FDA review other than the suicide issue. Lupus causes the immune system to attack the body's own tissue and organs, leading to arthritis, kidney damage, chest pain, fatigue, skin rash and other problems. Collins Stewart analyst Salveen Richter said the FDA documents show the agency recognized the need for new lupus treatments. "However, given the marginal efficacy of the drug, they're weighing the safety profile of the product," Richter said. "We still think, given the unmet need, that there's a high likelihood it gets approved," Richter said, noting the stock did not trade down very sharply.

Richter predicts the drug will eventually garner peak global sales of at least $4 billion. Human Genome shares were down 4 percent, or $1.06, at $25.42 in early Nasdaq trading, while GlaxoSmithKline shares slipped 0.6 percent in London. (Additional reporting by Lewis Krauskopf; Editing by Phil Berlowitz, Derek Caney) Keywords: HUMANGENOME LUPUS/ (lisa.richwine@thomsonreuters.com +1 202 310-5691; Reuters Messaging: lisa.richwine.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved.

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