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.

Roche (RHHBY - Analyst Report) recently announced that the company received a positive opinion for rheumatoid arthritis drug RoACTEMRA (tocilizumab) from the Committee for Medicinal Products for Human Use (CHMP).

Roche is seeking approval of the drug for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients (aged two years or more) who have responded inadequately to previous treatment with methotrexate (MTX).

We note that RoActemra is marketed as Actemra in the US. Actemra was approved in 2012 in the US for moderate to severe rheumatoid arthritis in adults who did not response adequately to one or more disease-modifying antirheumatic drugs (DMARD).

The CHMP’S POSITIVE opinion regarding RoActemra’s expanded usage was based on encouraging results from the phase III CHERISH study in children suffering from PJIA. Data revealed that patients treated with RoACTEMRA experienced clinically meaningful improvement in signs and symptoms of PJIA.

The positive opinion by the CHMP will be reviewed by the European Commission, which should issue a final decision in two to three months. The European Commission generally follows the recommendations of the CHMP. 

Concurrent with this news, Roche also announced that the CHMP has recommended conditional approval of oncology drug Erivedge (vismodegib).

Erivedge has been recommended for treating adults with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma who are not suitable for surgery or radiotherapy.

We note that a conditional marketing authorization is generally granted to a pharmaceutical product when the benefit of the same outweighs the inherent risk. Roche will require to submit additional data for full approval. It is generally granted to candidates that fulfill an unmet medical need.

We also note that Roche is developing Erivedge under a collaboration agreement with Curis, Inc (CRIS - Snapshot Report).  It was approved in the US in Jan 2012 for treating patients with advanced basal cell carcinoma. Erivedge generated sales of CHF 13 million in the first quarter of 2013.

We are encouraged with the positive bout of news at Roche.

Roche currently carries a Zacks Rank #4 (Sell). Right now, stocks which look well placed, include UCB SA (UCBJF) and WuXi PharmaTech (Cayman) Inc. (WX - Snapshot Report). Both stocks carry 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%