Sanofi to Stop Fedratinib Development - Analyst Blog


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Sanofi ( SNY ) 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 essential thrombocythemia.

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.

Other Setbacks

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 quarters.

Sanofi carries a Zacks Rank #3 (Hold). Right now, Bayer ( BAYRY ) and Johnson & Johnson ( JNJ ) look well positioned. Both carry a Zacks Rank #2 (Buy). Actelion Ltd. ( ALIOF ) appears to be more attractive with a Zacks Rank #1 (Strong Buy).


BAYER A G -ADR (BAYRY): Free Stock Analysis Report

JOHNSON & JOHNS (JNJ): Free Stock Analysis Report

SANOFI-AVENTIS (SNY): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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