Back to top

Analyst Blog

Zacks Equity Research

CHMP for JNJ's Zytiga Label Expansion

MDVN JNJ

 ZacksTrade Now

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Johnson & Johnson’s (JNJ - Analyst 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. (MDVN - Analyst Report). 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).

 

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
DIXIE GRP IN DXYN 15.84 +7.90%
BOFI HLDG IN BOFI 85.30 +4.97%
RAMBUS INC RMBS 12.31 +4.41%
VIPSHOP HOLD VIPS 148.73 +4.35%
NETFLIX INC NFLX 345.74 +4.32%