Bristol-Myers Squibb Company
) recently suffered a pipeline setback when it voluntarily decided
to halt a phase II study of its hepatitis C candidate,
BMS-986094 (formerly known as INX-189) due to a safety issue.
Even though it has not yet been determined whether
Bristol-Myers' hepatitis C candidate was responsible for the safety
issue, the company is assessing the safety of all the patients in
the trial. Following the completion of the safety assessment,
Bristol-Myers intends to take appropriate action.
We remind investors that BMS-986094 was added to Bristol-Myers'
pipeline following its acquisition of Inhibitex Inc. earlier this
We note that the setback concerning BMS-986094 is the second
pipeline-related disappointment at Bristol-Myers over the last
month. In July 2012, Bristol-Myers' brivanib performed
disappointingly in a phase III study (BRISK-FL) in the
hepatocellular carcinoma indication.
Moreover, in June 2012, the company suffered a regulatory
setback when the US Food and Drug Administration (FDA) declined to
) anti-clotting drug Eliquis (apixaban) on the basis of the
submitted data and issued a complete response letter. Bristol-Myers
and Pfizer are looking to get the blood thinner approved in the US
for preventing strokes and systemic embolism in patients suffering
from nonvalvular atrial fibrillation (AF). AF refers to a cardiac
rhythm disorder characterized by an erratic heartbeat.
Such pipeline/regulatory setbacks have the potential to be major
hindrances as Bristol-Myers aims to regroup following the loss of
exclusivity of blockbuster blood-thinner Plavix in the US on May
17, 2012. The genericization of Plavix, co-developed with
), has caused significant revenue losses for Bristol-Myers.
Bristol-Myers is looking to combat the generic threat through
partnering deals and acquisitions. Apart from acquisitions and
partnership deals, Bristol-Myers is looking to introduce new
products to augment its product portfolio to combat the generic
We currently have a Neutral recommendation on Bristol-Myers. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
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