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Priority Review for Bayer/Onyx' Nexavar

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The U.S. Food and Drug Administration (:FDA) recently granted priority review to Bayer (BAYRY) and Onyx Pharmaceuticals Inc.’s (ONXX) Supplemental New Drug Application (sNDA) for Nexavar. Bayer and Onyx are looking to expand Nexavar’s label for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.

We note that the U.S. regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.

Bayer and Onyx are looking to get Nexavar’s label expanded in both the U.S. and the EU.  The companies’ regulatory filing on Nexavar was based on positive results from the phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial.

Results from the study revealed a significant increase in progression-free survival (PFS) of patients treated with Nexavar compared to placebo (10.8 months versus 5.8 months). Data revealed a 41% reduction in the risk of disease progression or cases of death in patients receiving Nexavar compared to patients under placebo.

We note that Nexavar is already approved for liver cancer and advanced kidney cancer in over 100 countries around the globe. Bayer reported Nexavar sales of €200 million in the second quarter of 2013, up 2.6% year over year. Further label expansion will boost Nexavar’s sales. However, the oncology market is extremely competitive given the presence of companies like Roche (RHHBY).

Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile, other stocks such as Actelion Ltd. (ALIOF) currently look attractive carrying a Zacks Rank #1 (Strong Buy).

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