The Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) recently provided a positive
) marketing authorization application for Provenge.
Dendreon is looking to get Provenge 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 those patients.
Previously, Dendreon also received a positive opinion from the
EMA's Committee for Advanced Therapy (CAT) for its marketing
application for Provenge.
We note that the CAT evaluates the quality, safety and
effectiveness of advanced-therapy medicinal products.
Furthermore, the committee is also responsible for following
scientific developments in the relevant area.
A final decision from the EU regulatory authorities on the
approval of Provenge is expected by the end of this year. We note
that though the European Commission is not bound to follow the
CHMP's decision, it generally does so.
Provenge, Dendreon's sole marketed product, is already approved
in the US for treating advanced prostate cancer since May 2010.
We remind investors that the drug performed disappointingly in
the first quarter of 2013 with sales declining roughly 17.6% year
over year to $67.6 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.
Management, however, stated in its first quarter 2013 conference
call that Provenge sales will rebound in the coming quarters. The
company expects its second quarter Provenge sales in the mid-$70
million range. The company also believes that 2013 Provenge sales
are expected to surpass the 2012 sales figure of $325 million.
We are encouraged with the positive CHMP opinion on Provenge's
regulatory approval in the EU. However, we remain concerned about
Dendreon's high dependence on Provenge for long-term growth.
Dendreon, a biotechnology company, presently carries a Zacks Rank
#3 (Hold). Meanwhile, other biotech companies such as
WuXi PharmaTech Inc.
) currently look better positioned. Both WuXi Pharma and Elan
carry a Zacks Rank #2 (Buy).
DENDREON CORP (DNDN): Free Stock Analysis
ELAN CP PLC ADR (ELN): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
WUXI PHARMATECH (WX): Free Stock Analysis
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