Bad News for Bristol-Myers - Analyst Blog
August 27 2012 - 12:42PM
Zacks
Bristol-Myers Squibb Company (BMY) 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
patients.
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
month, Idenix Pharmaceuticals, Inc. (IDIX)
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/Pfizer’s (PFE) 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 Sanofi
(SNY), has caused significant revenue losses for Bristol-Myers.
Our Recommendation
We currently have a Neutral recommendation on Bristol-Myers. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
IDENIX PHARMA (IDIX): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Jun 2024 to Jul 2024
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Jul 2023 to Jul 2024
Real-Time news about (MM) (NASDAQ): 0 recent articles
More Idenix Pharmaceuticals, Inc. (MM) News Articles