The HealthCare segment of Bayer (BAYRY) recently announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan approved Stivarga for the treatment of patients suffering from gastrointestinal stromal tumor (GIST) who have progressed following prior systemic cancer therapy.
The drug’s approval was based on positive results from Bayer’s phase III GRID (GIST – Regorafenib In Progressive Disease) study. Bayer enrolled 199 patients for the study suffering from metastatic and/or unresectable GIST and whose disease has progressed in spite of being previously treated with Novartis’ (NVS) Gleevec (imatinib mesylate) and Pfizer Inc.’s (PFE) Sutent (sunitinib malate).
Results from the study revealed that patients treated with Stivarga showed a statistically significant improvement in progression-free survival (PFS) in comparison to patients under placebo. Stivarga is also approved in the U.S. for the GIST indication.
We note that this is Stivarga’s second approval in Japan. In Mar 2013, the drug was approved for the treatment of patients suffering from unresectable, advanced/recurrent colorectal cancer (CRC).
Stivarga is already approved in the U.S. for treating patients suffering from metastatic CRC (mCRC), whose disease has progressed even after treatment with standard drugs. Bayer is also seeking EU approval of Stivarga for the treatment of mCRC. In Jul 2013, Bayer received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Stivarga in the mCRC indication.
A final decision from the EU regulatory authorities on the approval of Stivarga is expected by Dec 31, 2013. We note that though the European Commission is not bound to follow the CHMP’s decision, it generally does so. We believe that further market expansion will boost the drug’s sales potential.
Bayer presently carries a Zacks Rank #3 (Hold). However, other pharma stocks, such as Actelion Ltd. (ALIOF), currently look better positioned with a Zacks Rank #1 (Strong Buy).
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