Bristol Still Playing Catch-Up to Gilead in Hep C Drug Race

AMSTERDAM ( TheStreet) -- Hepatitis C drug developers dumped a ton of clinical data on investors this morning as a liver disease meeting gets underway in Amsterdam. An experimental triple combination therapy from Bristol-Myers Squibb ( BMY) appears a bit stronger than expected but is still way behind a competing regimen from Gilead Sciences ( GILD).

The Bristol-Myers therapy involves three different oral drugs -- daclatasvir, asunaprevir and BMS-791325 -- which attack the hepatitis C virus in different ways. In a mid-stage study enrolling genotype 1 patients naive to treatment, Bristol's combination therapy dosed for 12 weeks achieved a cure rate of 94 percent.

Two serious adverse events -- a kidney stone and narrowing of blood vessels in the brain -- were reported in the Bristol-Myers study, although investigators said neither was directly attributable to the experimental therapy.

Bristol-Myers plans to move this triple combination therapy into phase III studies later this year, but the company is well behind Gilead and Abbvie ( ABBV) in pursuing all-oral hepatitis C regimens. Gilead and Abbvie are likely to launch their own, competing oral hepatitis C therapies with equal or better efficacy next year.

Gilead's lead hepatitis C drug sofosbuvir has already been filed for approval with FDA and is expected to be approved later this year. Initially, sofosbuvir will be combined with injections of interferon and the pill ribavirin to treat hepatitis C patients, but Gilead is conducting phase III studies now that combine sofosbuvir with another oral drug that eliminate the need for injections.

At the meeting in Amsterdam this week, Gilead will be presenting data from the phase III studies of sofosbuvir which formed the basis for the initial FDA approval filing. For newly treated hepatitis C patients, cure rates range from 67% in genotype 2/3 patients treated with sofosbuvir plus ribavirin to 90% for genoptype 1/4/5/6 patients treated with sofosbuvir, interferon and ribavirin.

Gilead shares were up less than 1% to $54.55 Tuesday but the stock is has been trading at or near all-time highs due to investors' high expectations for its new hepatitis C drug franchise achieving multi-billion dollar peak sales.

Bristol-Myers shares were up 1.5% to $42.56.

The new hepatitis C drug data are being presented at the European Association for the Study of the Liver's (EASL) annual meeting.

-- Reported by Adam Feuerstein in Boston.

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