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Biogen Idec Shares Slides as MS Drug is Linked to Inflammation

By Pharmaceutical Processing | October 22, 2014

CAMBRIDGE, Mass. (AP) — Shares of Biogen Idec slumped 8 percent Wednesday despite a strong quarter after the company said a patient who took its newest multiple sclerosis drug suffered a brain inflammation and later died.

The company confirmed there was a case of progressive multifocal leukoencephalopathy, or PML, in one patient who took the drug Tecfidera. It said the patient recently died of complications of pneumonia. Biogen said the patient took Tecfidera for four and a half years, and for most of that time experienced a condition that is a known risk factor for PML. The company reported the situation to regulators, and said it believes the overall risks and benefits of Tecfidera haven’t changed.

An older Biogen multiple sclerosis drug, Tysabri, was withdrawn from the market for a time because three patients contracted PML, which is rare and often fatal. The drug was eventually returned to sale under restricted conditions.

Shares of Biogen Idec declined $26.16 to $300.61 in midday trading.

Biogen said the Tecfidera patient who died suffered a severe case of lymphopenia, a reduction in a type of white blood cell. That condition is a known risk factor for PML and it has a variety of causes. The warning label for Tecfidera says the drug’s side effects can include a reduced white blood cell count.

Biogen Idec Inc. reported its third-quarter results on Wednesday and said revenue from Tecfidera rose to $787 million, almost triple the total sales from a year ago. The once-per-day pill was approved in the U.S. in early 2013 and received approval from European Union regulators in February. Still, Citi Investment Research analyst Yaron Werber said sales of the drug were $50 million less than he expected.

The Cambridge, Massachusetts, company said Wednesday that its net income grew to $3.62 per share in the second quarter. Excluding one-time items Biogen said it earned $3.80 per share, and its revenue rose to $2.51 billion.

Analysts expected net income of $3.43 per share and $2.51 billion in revenue according to a survey by Zacks Investment Research.

The company is now forecasting an adjusted profit of $13.45 to $13.55 per share in 2014, up from $12.90 to $13.10 per share. FactSet says analysts expect $13.10 on average.

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