Good News for Roche - Analyst Blog

By
A A A

The US Food & Drug Administration (FDA) recently approved Roche Holdings Ltd. 's ( RHHBY ) Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME).

Lucentis is the first and only medicine to be approved by the FDA for the treatment of DME in more than 25 years. Before Lucentis' FDA-approval, the standard of care for DME in the US has been laser surgery.

We note that this is the third indication for Lucentis in the US. First, the FDA approved the drug for the treatment of wet age-related macular degeneration (AMD) in 2006. Then, in 2010, Lucentis got FDA approval for macular edema following retinal vein occlusion (RVO). Roche expects to begin shipment for the latest indication of the drug by August 15 this year.

Lucentis is marketed in the US by Genentech, a member of the Roche Group and outside the US by Novartis AG ( NVS ).

We remind investors that Lucentis' FDA-approval for DME was based on Genentech's phase III trials, RIDE and RISE.

Apart from Lucentis' FDA-approval, Roche recently announced that a phase III study of Avastin along with radiation and temozolomide chemotherapy in patients newly diagnosed with glioblastoma met its co-primary endpoint. The study showed a significant improvement in progression-free survival (PFS) in patients with glioblastoma.

Roche is planning to discuss the phase III results with regulatory authorities around the world including the European Medicines Agency (EMA) and the FDA. The company expects final data on overall survival and other co-primary endpoints in 2013.

We note that Avastin is currently approved in more than 30 countries worldwide including the US for the treatment of glioblastoma as a single agent and in combination with irinotecan in some countries. US approval came under the FDA's accelerated approval program.

Roche headquartered in Basel, Switzerland, carries a Zacks #4 Rank (short-term Sell rating).


 
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
 
(RHHBY): ETF Research Reports
 
To read this article on Zacks.com click here.
 
Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: AMD , NVS , PFS , RHHBY

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Quick on Your Feet
Quick on Your Feet                  
Early Entrepreneurship
Early Entrepreneurship              
Trying to Be Goofy
Trying to Be Goofy                  

Stocks

Referenced

Most Active by Volume

48,099,947
  • $16.09 ▲ 0.50%
40,277,806
  • $102.50 ▲ 0.24%
40,236,499
  • $19.57 ▲ 2.35%
31,092,510
  • $49.75 ▲ 0.65%
30,795,218
  • $34.92 ▲ 0.78%
29,910,855
  • $3.63 ▲ 0.83%
24,019,154
  • $13.06 ▼ 0.38%
23,753,906
  • $74.82 ▲ 1.31%
As of 8/29/2014, 04:04 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com