Bristol-Myers Squibb Company
) recently suffered a pipeline setback when it announced the
discontinuation of the development of its hepatitis C candidate,
BMS-986094 (formerly known as INX-189) due to a safety issue.
Earlier this month, Bristol-Myers had voluntarily suspended a phase
II study following heart failure of a patient in the trial. The
patient subsequently died.
Following the safety concern and Bristol-Myers' voluntary action,
the US Food and Drug Administration (FDA) put the candidate on
clinical hold. We remind investors that BMS-986094 was added to
Bristol-Myers' pipeline following its acquisition of Inhibitex Inc.
earlier this year.
Bristol-Myers reported that nine patients from the study have been
hospitalized to date (including the patient who died). Two patients
are still in hospital. Even though the causes of these adverse
events have not yet been exactly identified, the pharma major
voluntarily suspended the trial keeping in mind the safety of the
Bristol-Myers is working with the FDA on the issue and further
announced that it will recognize a charge of $1.8 billion in its
third quarter earnings results, as a result of the termination of
the development of BMS-986094.
Bristol-Myers intends to share the data from the phase II study
with other companies developing hepatitis C candidates. We remind
investors that Bristol-Myers is not the only company to have
suffered a hepatitis C related pipeline setback. Earlier this
Idenix Pharmaceuticals, Inc.
) received a verbal notice from the FDA placing a partial clinical
hold on its hepatitis C candidate, IDX184.
We note that Bristol-Myers has encountered quite a few pipeline
setbacks this year. 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 FDA declined to approve Bristol-Myers/
) anti-clotting drug Eliquis (apixaban) on the basis of the
submitted data and issued a complete response letter.
Such pipeline/regulatory setbacks pose major challenges as
Bristol-Myers aims to recoup from 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.
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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