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Serono hit by two late-stage failures

Published on 08/04/05 at 11:21am

Serono has halted development of a late-stage psoriasis drug and stopped another trial for a new skin cancer drug.

Both drugs had reached phase III clinical trials and the news is a serious setback to the biotech company's plans to lessen its reliance on top-selling multiple sclerosis treatment Rebif

Clinical trials for Onercept, a treatment for moderate-to-severe psoriasis, were stopped on the recommendation of a Data and Safety Monitoring Board after two patients in clinical trials were diagnosed with sepsis, one of whom died.

Serono said that although sepsis is a recognised potential risk factor with anti-tumour necrosis factor (TNF) therapies such as Onercept, the safety board decided its risk-benefit profile was not good enough for it to continue in clinical development.

The company has also stopped developing Canvaxin as a treatment for stage IV melanoma on the recommendation of a separate drug safety board after data from a phase III clinical showed it was unlikely to be better than placebo.

Franck Latrille, head of global product development at Serono said: "We support the recommendation of the two Data and Safety Monitoring Boards and will continue to develop Canvaxin in stage III melanoma."

A further analysis of Canvaxin trial data for stage III melanoma is due in the third quarter of this year with a final analysis expected in mid-2006. The drug cost Serono $37 million in December last year as part of a collaboration for its development and commercialisation with Californian biotech company CancerVax.

The skin cancer treatment was intended to establish a presence for Serono in oncology, boosted by the company's work on dermatology treatments such as Raptiva.

Psoriasis treatment Raptiva was launched in Europe in November and made $4.9 million in sales last year. But Serono's star performer continued to be Rebif, which last year accounted for just over half of Serono's entire product sales.

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