Say goodbye to Eli Lilly's ill-fated sepsis drug Xigris. Results of a new study showed that the drug didn't help patients with septic shock live any longer than a placebo did, so Lilly is pulling it. "While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use," Lilly CMO Timothy Garnett said in a statement.
It's a disappointing end for a drug that once seemed so promising. When it was approved 10 years ago, Xigris was hailed as a potential blockbuster, but sales never really took off. The drug's labeling was narrow, so doctors had a hard time determining which patients would be suited for the treatment. Then there was the fact, pointed out in a New England Journal of Medicine article, that efficacy data wasn't strong. Last year, the drug managed just $104 million in sales.
European regulators had approved Xigris under "exceptional circumstances," meaning that an EMA committee had to review the drug's risk-benefit balance every year. In 2007, the Committee for Medicinal Products for Human Use decided that the data supporting Xigris' approval hadn't been borne out in later studies; it asked for a new placebo-controlled trial, Dow Jones reports.
That trial, PROWESS-SHOCK, prompted Lilly's decision to pull the drug. Retiring Xigris will cost Lilly up to $95 million in charges next quarter, or about 5 cents per share, the company said. Lilly will also lose that $100 million or so in sales, which may not seem like much compared with top seller Zyprexa, which had $5 billion in sales last year. But then again, Zyprexa's U.S. patent expired over the weekend. Right now, Lilly needs as many sales as it can get.
- see the statement from Lilly
- read the Dow Jones story
- get more from Bloomberg
- check out the Reuters article
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