Bristol Drops Hep C Drug After Patient Death

You could see this coming. Last night, Bristol-Myers Squibb abandoned an experimental hepatitis C compound after one patient died of heart failure and nine others were hospitalized during a Phase II study. The move comes less than a month after the drugmaker suspended the trial due to safety issues among patients and that decision, not surprisingly, immediately raised questions about the future of the medication (

The discontinuation is a huge disappointment for Bristol-Myers Squibb, which earlier this year agreed to pay $2.5 billion in cash for Inhibitex and its experimental compound, a nucelotide polymerase inhibitor that was renamed BMS-986094. The wisdom of that deal drew considerable skepticism, though, because the small drugmaker had completed only Phase I testing up to that point.

Although expensive, Bristol-Myers maintained that its rationale was sound, because hepatitis C is increasingly seen by Wall Street as the next huge market for new treatments. And since Bristol-Myers was also developing another compound, the deal would presumably offer a chance to become a big player in a growing field, especially since Gilead Sciences had recently paid a whopping $11 billion for Pharmasset, another small player. Now, Bristol-Myers will take a $1.8 billion charge, according to a filing with the US Securities and Exchange Commission.

"In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis," says Elliott Sigal, a Bristol-Myers exec vp and chief scientific officer, in a statement. The drugmaker noted that two patients remain hospitalized. The causes were not "definitely established," but involve heart and kidney toxicity.

The race to develop hepatitis C treatments is a hot area as several drugmakers seek to gain approval of a new generation of medicines for treating an estimated 170 million patients worldwide. Among others that may benefit from the Bristol-Myers setback are Gilead, Vertex Pharmaceuticals and Achillion Pharmaceuticals. The market is variously estimated at $20 billion for new pills that can work faster, but yield fewer side effects for patients with the liver infection.

As we noted earlier this month, this is only the latest disappointment for Bristol-Myers, by the way. Last month, the FDA again delayed appproval for the Eliquis bloodthinner, which is being jointly developed with Pfizer (read here), and a similar delay is hampering the dapagliflozin diabetes drug that is being developed with AstraZeneca (back story).