) announced negative top-line phase III data on oncology
candidate, iniparib and anticoagulant, otamixaban. Both phase III
studies did not meet the primary endpoint. Following the dismal
results, the company has decided to discontinue development of
both iniparib and otamixaban.
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A randomized phase III study (ECLIPSE, n = 780) evaluated the
efficacy and safety of iniparib in treatment naïve squamous
non-small cell lung cancer patients. The study compared iniparib
as an adjunct to Gemzar (gemcitabine)/Paraplatin (carboplatin)
versus a Gemzar/Paraplatin regimen. It was found that the
addition of iniparib to Gemzar and Paraplatin did not improve the
overall survival rate. Additionally, both arms of the study
showed similar results in terms of safety.
Moreover, iniparib was also being developed for
platinum-resistant ovarian cancer. However, top-line data from a
phase II study did not support further progress of the candidate
in this indication.
Based on these results, Sanofi has decided to stop development of
Meanwhile, a multi-center, randomized, double-blind
active-controlled phase III study (TAO, n >13,000) evaluated
the use of otamixaban versus heparin plus Integrilin in patients
with non-ST elevation acute coronary syndrome (NSTE-ACS) with
early invasive strategy planned. In the study, otamixaban
demonstrated lower-than-expected efficacy and did not exhibit
better risk-benefit than the comparator arm.
We are disappointed with the pipeline setbacks at Sanofi. We
remain concerned about the generic erosion confronting most of
Sanofi's key drugs including Plavix, Avapro, Lovenox, Taxotere,
Eloxatin and Xatral. The genericization of Avapro and Plavix is
expected to negatively impact Sanofi's business net income by
around €800 million in the first half of 2013.
Sanofi is looking to combat headwinds by containing operating
costs. Additionally, new product launches should make significant
revenue contributions in the upcoming quarters.
Sanofi carries a Zacks Rank #3 (Hold). Companies that currently
look attractive include
). All three carry a Zacks Rank #1 (Strong Buy).