subject: FDA Approves Sanofi Drug Jevtana [print this page] FDA Approves Sanofi Drug Jevtana FDA Approves Sanofi Drug Jevtana
Sanofi Aventis (SNY - Analyst Report) recently received good news in the form of US Food and Drug Administration (FDA) approval for its oncology drug, Jevtana (cabazitaxel). The FDA granted Sanofi approval for the application 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 of Jevtana, which is a big plus 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 Sanofi approval of Jevtana provides advanced-stage prostate cancer patients with a new treatment option. Being the only FDA approved regimen that radically improves overall survival in formerly treated patients, Jevtana should see considerable uptake on release. Jevtana is presently 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. Sanofi is in the process of building its oncology portfolio and at present 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, Regeneron Pharmaceuticals (REGN - Analyst Report), Exelixis (EXEL - Snapshot Report), Micromet (MITI - Analyst Report) and Merrimack among others.
Zacks Investment Research currently has a Neutral recommendation on Sanofi. The biggest concern for the stock is the high exposure to generic risk on many of its leading franchises, especially Lovenox. However, it is encouraged to see Sanofi's progress with its pipeline.
While different product launches like Jevtana 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 maintain earnings at positive, albeit modest, growth over the next few years.
Sanofi Aventis is also expected to grow revenue through additional partnering deals and acquisitions.
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