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Bristol Drops Hepatitis Drug, Takes Charge
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WSJ Aug 24 2012
By JONATHAN D. ROCKOFF
Bristol-Myers Squibb Co. said Friday it would take a $1.8 billion charge as a result of its decision to stop developing a hepatitis C drug after one patient died during clinical testing and eight others were hospitalized.
The pretax charge, disclosed in a regulatory filing, marks the rapid demise of one of Bristol's most recent and costly acquisitions, a $2.5 billion deal early this year to acquire Inhibitex Inc. and its drug informally called 094. Bristol had hoped the pill would help it join a $5 billion and growing market for treating hepatitis C, a liver disease that is the leading cause of liver transplants in the U.S.
Early this month, Bristol suspended testing of the pill after a patient developed heart failure. Late Thursday, Bristol said it was discontinuing the drug's development altogether, after the death and other hospitalizations, in the "interest of patient safety."
Two remain hospitalized and Bristol didn't provide information about their condition.
Bristol has another compound in development called daclatasvir, but the drug maker will have to find other companies willing to pair the compound with their own drugs in order to overcome the hepatitis C virus's ability to develop resistance to a single treatment.
The company also is exposed to the threat of litigation over the heart and kidney problems that developed during the phase 2 trial of 094. On Friday, a 60-year-old pediatric nurse from Corpus Christi, Texas, filed a product-liability lawsuit in a county court there seeking damages for her hospitalization for heart and kidney failure while participating in the study.
In the lawsuit, the woman, Janet Vella, alleged she was told to keep taking 094 even after showing signs of heart problems and now needs a heart transplant. "She was extremely healthy. She was a jogger. She was prescreened and had no heart problems, and within two weeks, her heart had been shredded by this drug," Robert Hilliard, Ms. Vela's lawyer, said in an interview.
The company doesn't comment on pending litigation and hadn't received the lawsuit, a Bristol spokeswoman said.
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