Back to top

Analyst Blog

Roche (RHHBY - Analyst Report) recently received encouraging news with its skin cancer drug Erivedge gaining conditional approval from the European Commission for the treatment of symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC in adults who are not suitable for surgery or radiotherapy.

We remind investors that EU conditional approval was expected as the Committee for Medicinal Products for Human Use (CHMP) had recommended for the same in Apr 2013.

We note that conditional marketing authorization is generally granted to a pharmaceutical product when the benefit of the same outweighs its inherent risk. It is usually granted to candidates that fulfill an unmet medical need.

Roche is, however, required to submit additional data.

The conditional approval was based on positive results from a phase II study, ERIVANCE, wherein it was observed that Erivedge substantially shrank lesions in approximately 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC.

We also note that Roche is developing Erivedge under a collaboration agreement with Curis, Inc. (CRIS - Snapshot Report). Roche is currently assessing the safety profile of Erivedge in an open label study, STEVIE.

Erivedge was approved in the US in Jan 2012 for treating patients with advanced BCC and initial uptake of the drug has been encouraging. Erivedge is approved in Switzerland, Australia, Israel, South Korea, Mexico and Ecuador.

Erivedge generated sales of CHF 13 million in the first quarter of 2013. The conditional approval in Europe and subsequent full approval will boost sales further.

Roche was in the news recently when it was rumored that it is eyeing Alexion Pharmaceuticals (ALXN - Analyst Report) in a bid to diversify its product portfolio.

Alexion Pharma’s sole marketed drug Soliris is approved for the treatment of paroxysmal nocturnal hemoglobinuria, a rare genetic disorder.

We expect investor focus to remain on further updates on Roche’s portfolio expansion plans.

Roche currently carries a Zacks Rank #4 (Sell). Right now, Jazz Pharmaceuticals (JAZZ - Analyst Report) looks attractive 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

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
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%