) HealthCare unit and
) recently announced that they have received priority review for
their oncology candidate, regorafenib, in the US.
Bayer had filed for Food and Drug Administration (FDA) approval
in April 2012. Bayer is looking to get regorafenib approved for the
treatment of metastatic colorectal cancer (mCRC) in patients whose
disease has progressed despite prior treatment.
Priority review status means that the FDA will review the
marketing application within 6 months instead of the standard 10
months. A response should be out in the fourth quarter of 2012.
Regorafenib's approval would be a major boost for the companies.
Onyx Pharma is entitled to receive a 20% royalty on any future
worldwide net sales of regorafenib in oncology. Bayer and Onyx
Pharma intend to co-promote regorafenib in the US. Bayer is also
seeking regulatory approval for regorafenib in the EU.
We currently have a Neutral recommendation on both Bayer and
Onyx Pharma. While Bayer carries a Zacks #4 Rank (short-term Sell
rating), Onyx Pharma carries a Zacks #3 Rank (short-term Hold
rating). Onyx Pharma has an important event coming up with the FDA
expected to deliver its decision regarding the company's marketing
application for another oncology candidate, Kyprolis
The company received a significant boost recently with the FDA's
Oncologic Drugs Advisory Committee issuing a positive opinion for
Kyprolis. The panel recommended the clearance of the candidate for
the treatment of relapsed and refractory multiple myeloma in
patients who have received at least two prior therapies. A final
decision from the FDA should be out by July 27, 2012.
BAYER A G -ADR (BAYRY): Free Stock Analysis
ONYX PHARMA INC (ONXX): Free Stock Analysis
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