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Bayer ( BAYRY - Analyst Report) and partner Onyx Pharmaceuticals, Inc. recently submitted applications for the approval of Nexavar in the US and the EU for the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine (RAI).
Bayer and Onyx’ regulatory submissions were 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 showed that Nexavar improved progression-free survival significantly in comparison to placebo in RAI patients.
We note that Nexavar is already approved for the treatment of liver cancer and advanced kidney cancer in several countries around the world. The drug is also approved for the treatment of advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) in the EU.
Bayer was also in the news recently when the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on the approval of the company’s oncology drug Stivarga (regorafenib).
Bayer is looking to get Stivarga approved in the EU for the treatment of adults suffering from metastatic colorectal cancer (CRC) who were earlier treated with, or are not considered candidates for, available therapies like fluoropyrimidine based chemotherapy.
A final decision from the EU regulatory authorities on the approval of Stivarga is expected by Sep 30, 2013. We note that though the European Commission is not bound to follow the CHMP’s decision, it generally does so.
We note that Stivarga is already available in the US for treating patients suffering from mCRC, whose disease progressed even after treatment with standard drugs. Stivarga is approved for the same indication in Japan as well. Apart from the mCRC indication, Stivarga is also approved for the treatment of patients suffering from locally advanced, metastatic gastrointestinal stromal tumor (GIST) in the US. Bayer is also looking to get Stivarga approved for the GIST indication in Japan. Bayer also intends to expand the Stivarga label to include the hepatocellular carcinoma indication.
Meanwhile, Bayer recently suffered a setback along with partner Johnson & Johnson ( JNJ - Analyst Report) for their blood-thinner Xarelto. The US Food and Drug Administration (FDA) recently issued a complete response letter (CRL) to the supplemental New Drug Application (sNDA) of Xarelto for the reduction of risk of stent thrombosis in patients suffering from acute coronary syndrome (ACS).
Bayer, a large-cap pharma company, presently carries a Zacks Rank #4 (Sell). Meanwhile, large-cap stocks such as Novo Nordisk ( NVO - Analyst Report) currently look more attractive with a Zacks Rank #2 (Buy).