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Positive results for new lupus treatment

GSK and Human Genome Sciences have announced that Benlysta (belimumab) reduced systemic lupus erythematosus symptoms

GlaxoSmithKline (GSK) and Human Genome Sciences have announced that a Phase III study evaluating Benlysta (belimumab) in patients with systemic lupus erythematosus reduced symptoms in a year-long study.

The 865-patient study, known as Bliss-52, found Benlysta was more effective at easing pain, hair loss and skin rash than a placebo. Patients received one of two doses of the drug or a placebo.

At the lower dose, 51.7 per cent of patients showed improved symptoms compared with 43.6 per cent who took the placebo. At a higher dose, 57.6 per cent had improved symptoms.

The positive results were unexpected by analysts who cited disappointing data in earlier clinical trials and a history of failures for treatments of lupus, which triggers the immune system to attack healthy cells.

There is no cure for the disease which affects about five million people worldwide.

Analyst Yaron Werber of Citigroup said that "with this kind of data and this kind of indication you have a pretty good leverage on getting premium pricing." He added that the findings may lead to GSK making a bid for Human Genome, which holds rights on two late-stage drugs being tested by GSK: darapladib for coronary artery disease, and Syncria for type 2 diabetes.

The companies are conducting a separate 76-week trial of Benlysta, with data expected in November. If these results are also positive, the companies plan to apply for approval to sell it in the US, Europe and other countries in the first half of 2010.

Human Genome CEO Thomas Watkins expects blockbuster sales for Benlysta if it reaches market. Based on history of rheumatoid arthritis and multiple sclerosis treatments, the drug may fetch $15,000 to $20,000 a year per patient, generating annual revenue up to $2.9bn. 

21st July 2009

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