Merck KGaA (MKGAF) recently announced the submission of an application to the European Medicines Agency (EMA) for the approval of Erbitux (cetuximab) in combination with standard first-line platinum-based chemotherapy.
The company is seeking approval for the use of the combination therapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.
Merck KGaA’s filing is based on a new biomarker analysis of EGFR expression levels in tumors of patients in the phase III FLEX study. The study data demonstrated that the addition of Erbitux to standard chemotherapy increased the response rate among patients with high EGFR expression to 44.4% from 28.1%.
We note that Erbitux is already marketed worldwide for the treatment of colorectal cancer and squamous cell carcinoma of the head and neck (SCCHN).
Erbitux is originally an ImClone product, which was acquired by Eli Lilly and Co. (LLY) in 2008. Merck KGaA has the right to market Erbitux outside the US and Canada. In Japan, the drug is jointly developed and marketed by Eli Lilly, Merck KGaA and Bristol-Myers Squibb Co. (BMY). Moreover, Eli Lilly sells Erbitux in the US and Canada in collaboration with Bristol-Myers.
Earlier in the week, Merck KGaA entered into an agreement to acquire the microbiology unit of a German company, Biotest AG. The microbiology segment, which recorded sales of about €50 million in 2010, consists of the heipha Dr. Müller GmbH and the Hycon business. Apart from a presence in Germany, Biotest’s microbiology unit has subsidiaries in France, Japan and the United States.
The transaction is expected to close in the second half of 2011, subject to regulatory approval in Germany and Austria.
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