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Lilly to lose up to $95m on Xigris withdrawal

Eli Lilly & Company will face an impairment charge of between $75m and $95m after withdrawing sepsis treatment Xigris based on a new study demonstrating a lack of efficacy

Eli Lilly & Company will face an impairment charge of between $75m and $95m after withdrawing sepsis treatment Xigris (drotrecogin alfa) based on a new study demonstrating a lack of efficacy.

The impairment charge, to be taken in the fourth quarter of 2011, is a devaluation of the company based on poor estimates regarding Lilly's intangible assets – in this case, investigational Xigris.

The company now expects reported earnings per share to be between $3.84 and $3.89 for 2011, dropping from $4.58 recorded in 2010.

Lilly's withdrawal of Xigris is based on results of the PROWESS-SHOCK study, which showed the drug did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock.

The company said it was working with regulatory agencies on this withdrawal, and was in the process of notifying healthcare professionals and clinical trial investigators.

Dr Timothy Garnett, Lilly's senior vice president and chief medical officer said the results were "quite unexpected" and added that the advances in standards of care for sepsis treatment could potentially explain why Xigris failed to improve patient survival compared to placebo.

The European Medicines Agency (EMA) had asked Lilly to carry out the trial as a condition for continued market authorisation in Europe.

The agency said: 'At this stage physicians should not initiate treatment with Xigris in new patients and should stop ongoing treatment.'

The EMA's Committee for Medicinal Products for Human Use (CHMP) will look at the issue during its plenary meeting in November 2011.

26th October 2011

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