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CHMP for JNJ's Zytiga Label Expansion

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Johnson & Johnson’s (JNJ - Free Report) 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 (abiraterone acetate).

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 arm.

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.

Our Take

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 market is Medivation, Inc. . 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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