) has decided to discontinue its oncology candidate fedratinib.
The company was developing the candidate for three main forms of
myeloproliferative neoplasms: primary myelofibrosis, including
those previously treated with ruxolitinib; polycythemia vera; and
Sanofi has decided to halt all trials and terminate plans for
regulatory filings related to fedratinib. Sanofi took this
decision following a risk-benefit analysis. As per discussion
with the U.S. Food and Drug Administration (FDA), study
investigators, neurologists and neuro-radiologists, it was found
that fedratinib's safety issues outweighed the efficacy benefits.
The FDA had requested Sanofi to suspend all fedratinib studies,
while Sanofi conducted a thorough safety analysis after reports
of some patients participating in a fedratinib study suffering
from Wernicke's encephalopathy arose.
Over the last few months Sanofi has suffered quite a few
late-stage pipeline setbacks. We remind investors that in Jun
2013, Sanofi discontinued the development of oncology candidate,
iniparib and anticoagulant, otamixaban. The company took this
decision as both the pipeline candidates did not meet the primary
endpoint in phase III studies.
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. Sanofi is looking to combat headwinds by
containing operating costs. Additionally, new product launches
should make significant revenue contributions in the upcoming
Sanofi carries a Zacks Rank #3 (Hold). Right now,
Johnson & Johnson
) look well positioned. Both carry a Zacks Rank #2 (Buy).
) appears to be more attractive with a Zacks Rank #1 (Strong
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