Good news flowed in at
) when the U.S. Food and Drug Administration (FDA) approved their
drug Nexavar for an additional indication. The drug was approved
for the treatment of patients suffering from locally recurrent or
metastatic, progressive, differentiated thyroid carcinoma
refractory to radioactive iodine therapy.
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In Aug 2013, Nexavar was granted priority review designation in
the U.S. 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.
The U.S. approval of 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 median progression-free survival for patients treated
with Nexavar compared to patients under placebo. Data revealed a
41% reduction in the risk of disease progression or death for
patients receiving Nexavar compared to those in the placebo arm.
Nexavar is already a key oncology product at Bayer and is
approved for liver cancer and advanced kidney cancer in over 100
countries around the globe. In the EU, the drug is approved for
two other indications - for the treatment of hepatocellular
carcinoma and for the treatment of patients suffering from
advanced renal cell carcinoma who have an unsuccessful
interferon-alpha or interleukin-2 based therapy.
Bayer reported Nexavar sales of €204 million in the third quarter
of 2013, up 11.1% year over year on an adjusted basis. We expect
Nexavar sales to be boosted further with the label expansion.
However, the oncology market is extremely competitive given the
presence of companies like
Bayer, a large cap pharma company, presently carries a Zacks Rank
#2 (Buy) and so does Amgen. Another large-cap stock,
Johnson & Johnson
), also holds a comparable rank.