Sepsis Treatment Xigris No Longer Effective, Withdrawn From Markets

INDIANAPOLIS -- Drugmaker Eli Lilly and Co. is withdrawing the severe sepsis treatment Xigris from all markets because a recently concluded study showed that it is no longer effective.

Severe sepsis is blood poisoning caused by an aggressive bacterial infection that can cause major organ failure. It can develop as a complication from pneumonia or bacterial infections.

The Indianapolis company said Tuesday there is no safety issue with the drug, but a study started in 2008 found it failed to reduce mortality in patients with septic shock. Lilly said patients should stop taking Xigris, which U.S. regulators approved in 2001.

Analysts initially thought the drug could become a breakthrough treatment that reached $1 billion in annual sales. But regulators approved Xigris for a narrower patient population than many expected, and it never approached that mark. Xigris generated about $100 million in sales last year.

Lilly Chief Medical Officer Dr. Timothy Garnett said in a statement Tuesday that the results of the latest study were "quite unexpected." He noted that the standard of care for patients with severe sepsis has improved since Xigris was launched, and that may have played a role in the study results.

Lilly spokeswoman Tina Gaines said Tuesday that the drugmaker had given sales and marketing rights for Xigris in the United States and Puerto Rico to a privately held company, but it still had those rights in other countries.

The Xigris announcement came the same day two generic drugmakers said they launched generic versions of Lilly's top-selling drug, the antipsychotic Zyprexa. U.S. patent protection expired Sunday for the drug, which brought in more than $5 billion in worldwide sales last year. Lilly has said it expects rapid sales erosion of the drug once the patent expires and cheaper generic drugs hit the market.

Lilly also loses U.S. patent protection for its second-best seller, the antidepressant Cymbalta, in 2013. The company plans to counter these revenue losses this by relying on its pipeline of drugs under development, its animal health business, emerging markets like China, and sales growth in Japan.

Lilly said Tuesday it will take a fourth-quarter, after-tax charge of about 5 cents per share for Xigris. But it still expects adjusted earnings of between $4.30 and $4.35 per share for 2011, which would result in a drop of between 8 percent and 9 percent compared with last year's results.

Company shares fell 39 cents, or 1 percent, to $37.80 in late morning trading, while the Dow Jones industrial average dropped about 1 percent.

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Source: http://www.huffingtonpost.com/2011/10/25/xigris-sepsis-treatment-not-effective_n_1030597.html

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