Roche suspends drug development

Swiss-based pharmaceutical giant Roche have confirmed that, along with their partner Biogen Idec, they are to suspend the development of their late-stage rheumatoid arthritis treatment ocrelizumab. The news comes after new data surfaced that points to serious infections that can cause death.

The recommendation to suspend development came following the results of an independent data and safety monitoring board that had been assessing the compound in four RA studies and two lupus trails. Roche reports that the board concluded the safety risk of ocrelizumab "outweighed the benefits observed in these specific patient populations at this time."

Fatalities

According to the Data Safety Monitoring Boards (DSMB) review, "serious and opportunistic infections, some of which were fatal", were detected. "Previously, a FILM study which had evaluated ocrelizumab, a humanise anti-CD20 therapy, in methotrexate-naive RA patients was placed on clinical hold, while the BELONG study in lupus nephritis patients was previously halted due to "serious and opportunistic infection signals," it said.

Suspension of the clinical trials was disclosed in Switzerland by Roche, the global pharmaceutical giant that has the larger stake in the success of the new drug than Biogen Idec. Neither Roche nor Biogen Idec would say how many patients have died from infections related to the experimental drug, or where they lived, but the companies suggested those breakdowns might be disclosed at a medical forum in the future.

Review

Roche added that ocrelizumab is still being evaluated for relapsing multiple sclerosis in an ongoing Phase II study.

The companies' partnership was originally struck in the mid-1990s by California biotechs Genentech Inc. and Idec Pharmaceuticals Corp., which developed Rituxan. Idec was acquired by Biogen in 2003, forming Biogen Idec, while Genentech was purchased by Roche last year.

Biogen Idec and Genentech extended their partnership in 2003 to cover ocrelizumab, a second-generation molecule that targets the same disease pathways as Rituxan. But unlike Rituxan, which is made using mice cells, the new drug is derived from human cells. Both treat rheumatoid arthritis, an autoimmune disease that leads to inflammation of the joints, and lupus, another chronic inflammatory disease. However, now that fatalities have been disclosed, the likelihood of approval has been significantly diminished.

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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