The European Commission (EC) has recently granted marketing
) Provenge. The drug is approved in the EU for the treatment of
asymptomatic or minimally symptomatic metastatic (non-visceral)
castrate resistant prostate cancer in adults. Chemotherapy is not
yet clinically indicated for these patients.
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The EU approval of Provenge does not come as a surprise as, in
Jun 2013, the Committee for Medicinal Products for Human Use of
the European Medicines Agency (EMA) provided a positive opinion
on the approval of the drug. Dendreon also received a favorable
opinion from the EMA's Committee for Advanced Therapy (CAT) on
its marketing application for Provenge.
Provenge's approval in the EU was based on positive results from
the phase III IMPACT (n=737) study in patients suffering from
prostate cancer. Results from the study revealed an improvement
in overall survival in patients treated with Provenge compared to
those in the placebo arm.
Provenge, Dendreon's sole marketed product, has been approved in
the U.S. for treating advanced prostate cancer since May 2010. We
remind investors that the drug performed disappointingly in the
second quarter of 2013 with sales declining 8.4% to $73.3
million. The sharp decline in Provenge sales was primarily due to
the entry of
Johnson & Johnson
) Zytiga in the prostate cancer market in Dec 2012.
Meanwhile, management stated in its second quarter 2013
conference call that Provenge sales will not be able to beat the
2012 sales figure of $325.3 million. Though encouraged by the EU
approval, we remain concerned about the decreasing trend of
Provenge sales. We are also concerned about Dendreon's high
dependence on Provenge for growth.
Dendreon carries a Zacks Rank #3 (Hold). Meanwhile companies such
Biogen Idec Inc.
) look better positioned with a Zacks Rank #1 (Strong Buy).