Merck KGaA Withdraws Erbitux MAA - Analyst Blog

By
A A A

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 ). 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 ) 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.


 
BRISTOL-MYERS (BMY): Free Stock Analysis Report
 
LILLY ELI & CO (LLY): Free Stock Analysis Report
 
(MKGAF): ETF Research Reports
 
THRESHOLD PHARM (THLD): Free Stock Analysis Report
 
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: BMY , LLY , MAA , MKGAF , PFS

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

ColonialMills_USETBASITE
ColonialMills_USETBASITE            

Stocks

Referenced

Most Active by Volume

81,768,754
  • $74.11 ▼ 2.31%
77,395,717
  • $9.42 ▼ 5.80%
67,947,205
  • $17.02 ▲ 0.18%
53,864,169
  • $32.58 ▼ 3.95%
44,748,631
  • $11.32 ▲ 0.98%
42,926,278
  • $9.97 ▼ 9.03%
42,401,116
  • $41.80 ▼ 0.67%
39,870,972
  • $106.98 ▼ 0.34%
As of 10/30/2014, 04:15 PM

Find a Credit Card

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