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Inhibitex's Tox

How in vitro tox presaged Bristol-Myers' costly failure with Inhibitex HCV drug

Bristol-Myers Squibb Co. may have looked pastin vitro safety signals in a rush to add Inhibitex Inc.'s nucleoside NS5B polymerase inhibitor to its HCV portfolio. If the pharma was gambling that it could find a therapeutic window for BMS-986094 as it had previously done with blockbuster entecavir in HBV, the bet backfired.

In August, BMS first suspended and then terminated development of BMS-986094 after nine patients in a Phase II trial were hospitalized with heart and kidney toxicities, including one patient who died of heart failure.

Whether and when BMS saw the first signs of a possible problem is unclear.

Publicly disclosed results from earlier clinical trials would have offered BMS no clues about the potential risks. However, at least some researchers say red flags raised by in vitro studies have been in plain sight for years.

The pharma declined to discuss what data it considered in its due diligence prior to acquiring Inhibitex for $2.5 billion in January. BMS-986094 (formerly INX-189) was the primary driver of the acquisition (see BioCentury, Jan. 16).

The $26 per share price was a 163% premium to the biotech's prior close. The news came two months after Gilead Sciences Inc. paid $11 billion - an 89% premium - to acquire Pharmasset Inc. to get the biotech's nucleotide inhibitor, now called GS-7977.

"It is safe to assume that BMS had been

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