FDA Approves Sanofi Drug - Analyst Blog

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) recently received good news in the form of US Food and Drug Administration (FDA) approval for its oncology drug, Jevtana (cabazitaxel). The FDA granted approval for the use of Jevtana in combination with prednisone for the treatment of metastatic hormone-refractory prostate cancer (mHRPC) patients who were previously treated with a Taxotere (docetaxel)-containing treatment regimen. 

The approval, which is a major positive for Sanofi, came about three months before the September PDUFA date. Phase III results on Jevtana showed that treatment with Jevtana in combination with prednisone resulted in a statistically significant reduction in the risk of death compared to treatment with mitoxantrone and prednisone. 

The approval of Jevtana provides advanced-stage prostate cancer patients with a new treatment option. Being the only FDA approved regimen that significantly improves overall survival in previously treated patients, Jevtana should see significant uptake on launch. Jevtana is currently under regulatory review in other territories, including the European Union. 

Prostate cancer remains the second most common cause of cancer death in the US and it is estimated that about 217,730 new cases of prostate cancer will be detected in the US in 2010. About 32,050 men are expected to die from prostate cancer in 2010. 

Sanofi’s leading oncology products are Taxotere and Eloxatin. The company is working on building its oncology portfolio and currently has a wide range of novel agents in its oncology pipeline including BSI-201, alvocidib, and aflibercept among others. While some of these candidates are being developed by Sanofi itself, others are being developed in collaboration with companies like BiPar Sciences,

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We currently have a Neutral recommendation on Sanofi. Our biggest concern for the stock is the high exposure to generic risk on many of its leading franchises, especially Lovenox. However, we are encouraged to see Sanofi’s progress with its pipeline.

While new product launches should make significant revenue contributions in the early part of the decade, we expect Sanofi to continue look to contain operating costs in order to grow earnings in the face of weakening sales of some of its biggest products. This should help keep earnings at positive, albeit modest, growth over the next few years.

We also expect Sanofi to grow revenue through additional partnering deals and acquisitions.