Back to top

Analyst Blog

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.

Medivation, Inc. (MDVN - Analyst Report) and partner, Astellas Pharma, Inc. (ALPMY), recently gained EU approval for their prostate cancer drug, Xtandi. Xtandi, a novel androgen receptor antagonist, was approved for treating metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after docetexal therapy.

Xtandi can also be marketed in Iceland, Liechtenstein and Norway, which come under the European Economic Area (EEA). Xtandi showed positive results from the phase III study, AFFIRM, which led to this approval. EU approval does not come as a surprise as Xtandi had received a positive opinion from the Committee for Medicinal Products for Human Use in Apr 2013.

Medivation has seen growing sales of Xtandi ever since it was launched in the US in Sep 2012. Medivation reported 1Q13 Xtandi net sales of $75.4 million, $18 million above the last quarter of 2012.

The prostate cancer market represents huge commercial potential. According to the American Cancer Society, 242,000 new cases of prostate cancer were diagnosed in the US in 2012, with 238,590 cases expected to be diagnosed this year. 

EU approval is a major positive for Medivation. The company is entitled to receive a $15 million milestone payment from Astellas based on the EU approval of Xtandi. Medivation’s collaboration agreement with Astellas for Xtandi was signed in 2009.

Medivation and Astellas are looking to get Xtandi approved in additional countries like Switzerland, South Korea, Brazil, Japan and Australia.

Moreover, the companies are working on expanding Xtandi’s label. Interim results from the phase III PREVAIL study on pre-chemo patients should be out later this year. The company also intends to start a phase III trial in patients with non-metastatic castration-resistant prostate cancer this year. Xtandi is being evaluated in other studies as well, including a breast cancer study.

Currently approved prostate cancer therapies include Zytiga and Jevtana.

Medivation currently carries a Zacks Rank #3 (Hold). At present, companies like Jazz Pharmaceuticals (JAZZ - Analyst Report) and Santarus, Inc. look well positioned with a Zacks Rank #1 (Strong Buy).

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%