When GlaxoSmithKline’s (NYSE:GSK) lupus drug Benlysta was approved in 2011 the company and some pharmaceutical industry observers expected the drug to achieve blockbuster sales. It hasn’t turned out that way.
GSK now wants to see if pairing Benlysta with another drug can treat patients with a different inflammation condition. The company announced today it has started phase III clinical trials evaluating Benlysta in patients who have inflamed blood vessels, or vasculitis.
Lupus is characterized by inflammation throughout the body as the autoimmune disorder causes the body to attack its own tissues. In vasculitis the body’s immune system attacks blood vessels, causing them to become inflamed. The inflammation disrupts blood flow, which can damage the body’s organs. The clinical trial will evaluate Benlysta in combination with azathioprine, an already approved immunosuppressive drug that is used to treat forms of vasculitis.
Azathioprine used to be a GSK product marketed as Imuran. But after the drug lost patent protection, GSK sold that drug and others to South African firm Aspen Global in 2008. GSK is studying the Benlysta/azathioprine combination in patients who have a particular vasculitic disease called ANCA (Anti-neutrophil Cytoplasmic Antibodies) positive vasculitis.
The high hopes for Benlysta centered around its status as the first new lupus treatment in close to 50 years. The drug was discovered by Human Genome Sciences and developed through a partnership with GSK. GSK last year acquired HGS and its drug portfolio, allowing the British company to keep all the revenue from the partnered products rather than sharing it with a partner.
There hasn’t been much revenue to keep. Benlysta sales have been lackluster as GSK has faced challenges getting doctors to prescribe it and payers to cover it. Benlysta generated just $111 million in 2012 sales worldwide.
GSK maintains its U.S. headquarters in Research Triangle Park.
