Bloomberg News

GlaxoSmithKline’s Lupus Drug Rejected by U.K. Regulator

September 30, 2011

(Updates with analyst comment in sixth paragraph.)

Sept. 30 (Bloomberg) -- GlaxoSmithKline Plc and Human Genome Sciences Inc.’s Benlysta medicine was rejected by the U.K.’s health-cost agency as a treatment for the auto-immune disease lupus.

Data gathered by the agency failed to convince it that Benlysta was “value for money” compared with standard care, the National Institute for Health and Clinical Excellence said in a statement today announcing the preliminary decision. The agency said it will hold consultations on Benlysta until Oct. 21 and is open to comments.

The drug, an intravenous product also known as belimumab, won the backing of a European Union advisory panel in May as an add-on to standard therapy in adult patients suffering from systemic lupus erythematosus, the most common form of the disorder. It’s the first treatment designed specifically for lupus, a condition that affects about 5 million people.

“The initial decision is very disappointing for patients living with lupus who currently have very limited treatment options,” Simon Jose, general manager for London-based Glaxo in the U.K., said in an e-mailed statement today. “We will do everything we can to change NICE’s mind.”

Stricter on Medicines

Health-cost agencies throughout Europe are getting stricter on what medicines they back for reimbursement as governments rein in spending to reduce debt.

“NICE is one of the toughest health-cost agencies out there and it often rejects new products,” Philippe Lanone, an analyst at Natixis Securities in Paris, said in a telephone interview. “Benlysta had no reimbursement problems in other countries. NICE’s decision won’t have consequences on the product’s sales prospects.”

Lanone, who has a “neutral” recommendation on Glaxo shares, expects Benlysta to garner $2.6 billion in annual sales by 2017 for the U.K. company and Rockville, Maryland-based Human Genome.

Glaxo had previously agreed to a patient access program with the U.K. Department of Health, offering a discount on Benlysta’s list price. The treatment costs 121.50 pounds ($189) to 405 pounds a vial depending on the dose, NICE said.

“The cost per year of improved health is very high,” Carole Longson, a director at NICE, said in today’s statement.

NICE said it took into account opinions of people with lupus and clinical specialists.

About 15,000 people in England and Wales suffer from systemic lupus erythematosus, with about 90 percent of the cases occurring in women, NICE said. Benlysta is already sold in the U.S., Germany, Denmark, Sweden, Austria, Norway, Finland and Canada, according to Glaxo.

--Editors: Thomas Mulier, David Risser

To contact the reporter on this story: Albertina Torsoli in Paris at

To contact the editor responsible for this story: Phil Serafino at

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