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.

Biogen Idec (BIIB - Analyst Report) recently presented full first-year phase III results on its multiple sclerosis candidate, Plegridy (peginterferon beta-1a).  Results from the ADVANCE study, which were initially reported in Jan 2013, showed that Plegridy met the primary endpoint as well as secondary endpoints.

Detailed Results

Plegridy was compared to placebo in the study that was conducted to evaluate the safety and efficacy of the candidate in patients suffering from relapsing-remitting multiple sclerosis (RRMS).

Plegridy (dosed once in two weeks) met the primary endpoint of annualized relapse rate (ARR) at one year.  ARR reduction was 36% compared to placebo.

Secondary endpoints included reduction of the risk of 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (by 38%), reduction in the proportion of patients who relapsed (by 39%) and reduction in the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans (by 67%) compared to placebo. The number of gadolinium-enhancing (Gd+) lesions was reduced by 86% in the Plegridy arm.

These results were presented at the annual meeting of the American Academy of Neurology.  While a once-in-four weeks dosing regimen of Plegridy was also evaluated in the study, the once- every-two weeks dosing arm was more effective.

Meanwhile, with these positive results in hand, the company should be able to go ahead with its plans of filing for US and EU approval this year.

Our Take

We are pleased with Biogen's progress with its multiple sclerosis pipeline. A less frequent dosing schedule and a favorable safety and efficacy profile should work in Plegridy’s favor once it is launched.

Biogen is the market leader in therapies for the treatment of multiple sclerosis. We believe the company will continue to retain a leading position in the multiple sclerosis market. Biogen has an important regulatory event coming up with an FDA decision on its oral multiple sclerosis candidate, Tecfidera, expected in the coming days.  We believe Tecfidera could become a leader in the oral multiple sclerosis market once launched. Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie (ABBV - Analyst Report).

Biogen currently carries a Zacks Rank #2 (Buy). Other stocks that currently look more attractive include companies like Athersys, Inc. (ATHX - Snapshot Report), and Cytokinetics, Inc. (CYTK - Snapshot Report). Both are Zacks Rank #1 (Strong Buy) stocks.
 

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 GROUP DXYN 15.84 +7.90%
BOFL HOLDING 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%