Biogen Idec, Genentech’s Rituxan Fails in Pivotal Study of Lupus of Kidneys

Rituxan, the hit lymphoma drug from Genentech and Biogen Idec, has failed in yet another bid to expand into treating other diseases. The drug fell short of reaching the main goal in a final-stage study of 144 patients with lupus nephritis, an inflammatory disease of the kidneys.

The study, called Lunar, showed that patients who got a combination of immune-suppressing drugs in addition to rituximab (Rituxan) didn’t do significantly better those who got a placebo, Genentech said today in a statement. No new or unexpected safety issues popped up, the company said.

The two life sciences companies first formed a partnership to co-develop, and co-market the drug back in 1995, when rituximab’s developer, San Diego-based Idec Pharmaceuticals, was low on cash and needed help from Genentech to finish clinical trials for non-Hodgkin’s lymphoma. Genentech is based in South San Francisco, CA, and operates a manufacturing facility in Oceanside, CA, about 35 miles north of San Diego. Biogen Idec, based in Cambridge, MA, merged with Idec in 2003 and still retains a presence in the region.

Rituxan, approved in 1997 by the FDA as the world’s first targeted antibody drug for cancer, won an additional approval from U.S. regulators in 2006 for rheumatoid arthritis. The drug is designed to block excess B-cells of the immune system, which are culprits in non-Hodgkin’s lymphoma, as well as autoimmune diseases. After showing positive early signs in clinical trials, the drug failed last year in the final phases of development for multiple sclerosis, lupus that circulates throughout the body, and now lupus of the kidneys. The drug is a major revenue driver for both Genentech and Biogen Idec—it generated $2.6 billion in U.S. sales in 2008.

Genentech and Biogen Idec plan to continue to hunt for treatments of lupus nephritis based on findings from the study. “We plan to analyze the full set of data from this study and share the findings at an upcoming scientific meeting,” said Evan Beckman, Biogen’s senior vice president of immunology R&D, in a statement.

An estimated 1.5 million to 2 million people in the United States have lupus, a disease in which the immune system goes haywire and starts attacking healthy tissue like it would a virus. About one-third are estimated to have the form that attacks the kidneys, Genentech and Biogen said.

The failure of rituximab is just the latest in a string of setbacks for lupus treatments. An experimental drug called Riquent from La Jolla Pharmaceutical failed last month in a study of 730 patients with lupus nephritis.

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