Johnson & Johnson's
) Janssen-Cilag International NV recently received a positive
opinion from the Committee for Medical Products for Human Use
(CHMP) of the European Medicines Agency (EMA) for its label
expansion efforts for prostate cancer therapy, Zytiga
Johnson & Johnson is looking to get Zytiga's label
expanded for use in chemotherapy-naïve metastatic
castration-resistant prostate cancer (mCRPC) patients who are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy. The company is also seeking approval in the
US for this indication.
The regulatory applications for the label expansion were filed
soon after Johnson & Johnson presented promising results from
pre-specified interim analyses of an international phase III,
randomized, double-blind, placebo-controlled COU-AA-302 study.
The study was conducted to evaluate the efficacy and safety of
Zytiga plus prednisone versus placebo plus prednisone. The
co-primary endpoints of the study were radiographic
progression-free survival (rPFS) and overall survival (OS).
Results indicated a statistically significant improvement in
rPFS and all secondary endpoints in the Zytiga arm. A trend for
increased median overall survival was also observed in the Zytiga
Zytiga, an oral, once-daily medication, is currently approved
for use in combination with prednisone for the treatment of mCRPC
in treatment-experienced patients whose chemotherapy contained
docetaxel. While US approval came in April 2011, EU approval was
granted in September 2011.
Zytiga is one of the most important and successful new product
launches at Johnson & Johnson. Approval for the
chemotherapy-naïve patient population would increase Zytiga's
sales potential significantly. If approved for the
chemotherapy-naive indication, Zytiga will be used in patients at
an earlier stage of their disease. We believe Zytiga, which
posted sales of $265 million in the third quarter of 2012 (up
14.2% on a sequential basis), has blockbuster potential. A
response regarding the label expansion in the US and the EU
should be out by year end and early 2013, respectively.
Another company that recently entered the prostate cancer
). Medivation and partner, Astellas Pharma Inc., gained FDA
approval for Xtandi for use in castration-resistant prostate
cancer patients who have received docetaxel therapy.
We currently have a Neutral recommendation on both Johnson
& Johnson and Medivation. While Johnson & Johnson carries
a Zacks #2 Rank (short term 'Buy' rating), Medivation carries a
Zacks #3 Rank (short term 'Hold' rating).
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