Friday, October 10, 2008

Biogen withdraws arthritis drug after trial failures

By Mass High Tech Staff

Cambridge biotech Biogen Idec has stopped the development of its rheumatoid arthritis drug, baminercept, after it failed to meet both its primary and secondary endpoints in a Phase 2 trial, company officials announced. The drug was intended to treat patients with rheumatoid arthritis who did not respond to treatment with a standard tumor necrosis factor (TNF) inhibitor.

The trial consisted of 380 rheumatoid arthritis-afflicted people participating in a random study using either placebos or the baminercept drug combined with methotrexate.

The primary endpoint showed the trial as having failed to improve at least half of the patients’ swollen joints after 14 weeks. The secondary endpoints were proportions of those with at least 20 percent improvement in patients’ baseline condition and those with at least 70 percent improvement in patients’ baseline condition.

Rheumatoid arthritis affects 1.3 million Americans, according to Biogen officials, and is marked by chronic swelling and breakdown of tendons, bones and cartilage.

In August, Biogen announced that its multiple sclerosis drug Tysabri was linked to two cases of progressive multifocal leukoenphalopathy (PML), a serious brain infection. The news comes after just two years of the drug clearing regulatory ‘re-approval’ following Biogen’s voluntary withdrawal of it in 2005 due to other case of PML. Biogen reported it had no plans to recall the drug again.

A month later, in September, Biogen and Irish drug partner Elan Corp. announced that they hage begun Phase 2/3 trials of the battered MS drug for treating  multiple myeloma.

With 4,300 workers worldwide, Biogen reported 2007 net income of $638.2 million on revenue of $3.2 billion.