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.

Merck KGaA (MKGAF) recently announced the withdrawal of the marketing authorization application (MAA) to the European Medicines Agency (EMA) for Erbitux (cetuximab) as the European regulatory authorities had asked the company to furnish additional data.

Merck KGaA was looking to get Erbitux approved for an additional indication. The company was seeking European approval of the drug, combined with standard first-line platinum-based chemotherapy in patients suffering from advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.

We note Erbitux is currently approved and marketed in the US and EU for the treatment of patients with colorectal cancer and squamous cell carcinoma of the head and neck (SCCHN). The withdrawal of the MAA for the additional indication does not undermine the proven efficacy of the drug for the approved indication. 

Earlier, in July 2012, Merck KGaA announced that Erbitux failed to achieve its primary endpoint in the phase III EXPAND trial, conducted in patients with advanced gastric cancer. Results showed that Erbitux plus cisplatin and capecitabine failed to significantly increase progression-free survival (PFS) in patients suffering from advanced gastric cancer.

Erbitux was originally developed by ImClone LLC, which is now a wholly-owned subsidiary of Eli Lilly and Co. (LLY - Analyst Report). Merck KGaA has the right to market Erbitux outside the US and Canada. The drug is jointly developed and marketed by Eli Lilly and Bristol-Myers Squibb Co. (BMY - Analyst Report) in the US, Japan and Canada.

Meanwhile, Merck KGaA provided an update on its oncology candidate, TH-302. The company and partner Threshold Pharmaceuticals, Inc. (THLD) intend to commence a randomized phase III study on the candidate. The study will evaluate TH-302 as a first-line therapy in patients suffering from pancreatic cancer.

We remind investors that in February 2012, Merck KGaA presented encouraging data from an open-label phase IIb study which evaluated TH-302, in combination with Eli Lilly’s Gemzar, for treating patients suffering from advanced pancreatic cancer.

The study met its primary endpoint by achieving a 63% improvement in PFS in patients treated with TH-302 and Gemzar in comparison to Gemzar alone.

Our Recommendation

Merck KGaA currently carries a Zacks #2 Rank (Buy rating) in the short run.

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%