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.

Regeneron Pharmaceuticals (REGN - Analyst Report) and partner, Bayer’s (BAYRY - Analyst Report) HealthCare unit  recently commenced a new phase III study (VIVID EAST-DME) to evaluate the efficacy and safety of their eye drug Eylea for treating patients suffering from diabetic macular edema (DME). The companies have initiated the study in Russia, China and other Asian countries.

The primary endpoint of the phase III study, which has three treatment arms, is the mean change in visual acuity from baseline to week 52. This will be measured by the early treatment diabetic retinopathy study eye chart.  Bayer/Regeneron intend to evaluate the patients in the study for a maximum period of one year.

We note that while Bayer is conducting the first phase III study (VIVID-DME) of Eylea in the DME indication in Europe and Japan, Regeneron is evaluating the drug in the same indication in another phase III study (VISTA-DME) in the US. Enrollment has been completed in both the studies.

As per the agreement between the companies on Eylea, Bayer is responsible for marketing the drug in ex-US markets on approval. The profit earned from the sales of the drug in those markets will be shared equally by the companies. In Japan, Regeneron is eligible to receive royalties on net sales of the drug. However, Regeneron owns the entire US rights pertaining to the eye drug.

Eylea is also being studied for other indications, such as macular edema following branch retinal vein occlusion and myopic choroidal neovascularization.

We note that Eylea is already available in the US since Nov 2011 for treating patients suffering from the neovascular form of age-related macular degeneration. The drug was cleared in the EU for the same indication late last year. In Sep 2012, the label of the drug was successfully expanded in the US to treat patients suffering from macular edema following central retinal vein occlusion (CRVO).

Regeneron, a biopharmaceutical company, also carries a Zacks Rank #3. Biopharma stocks, which are currently well placed include, Array Biopharma (ARRY - Snapshot Report) and Medivation, Inc. (MDVN - Analyst Report). Both stocks carry a Zacks Rank #2. Bayer also carries a Zacks Rank #2.

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
RAMBUS INC RMBS 12.56 +6.53%
DIXIE GROUP DXYN 15.46 +5.31%
BOFL HOLDING BOFI 85.39 +5.08%
NETFLIX INC NFLX 346.93 +4.68%
E COMMERCE C DANG 12.58 +4.14%