Bayer Seeks Regorafenib Approval

The HealthCare unit of Bayer (BAYRY - Analyst Report) recently submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for its cancer candidate regorafenib. Bayer is looking to get regorafenib, an oral multi-kinase inhibitor, approved for treating patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (GIST).

Bayer is seeking approval of the candidate on the basis of encouraging data from a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors. The disease had progressed in the evaluated patients in spite of being previously treated with Novartis’ (NVS - Snapshot Report) Gleevec and Pfizer’s (PFE - Analyst Report) Sutent. The data was presented at the June 2012 annual conference of the American Society of Clinical Oncology (ASCO).

We note that Bayer is also seeking approval of regorafenib for treating patients suffering from metastatic colorectal cancer (mCRC) both in Europe and the US. The marketing applications were based on encouraging data from a phase III study (CORRECT: n=760), which evaluated regorafenib in mCRC patients, whose disease had progressed even after treatment with the standard drugs prescribed for the disease.

The FDA announced in June 2012 that it will review the marketing application, filed in April 2012, for mCRC on a priority basis. Priority review status means that the FDA will review the marketing application within six months instead of the standard ten months. A response is expected in the fourth quarter of 2012.

Once regorafenib is commercialized, Bayer will have to make royalty payments on global sales of the candidate to Onyx Pharmaceuticals, Inc. (ONXX - Analyst Report), per an agreement inked last year.

Our Recommendation

We have a Neutral recommendation on Bayer. The stock carries a Zacks #3 Rank (Hold rating) in the short run.