Company: Merck KGaA, Bristol-Myers Squibb ($BMS)
2013 Global Sales: $1.87 billion
Indications: Colon and head and neck cancer

Normally, companies aim to expand their drugs' labels to score sales from multiple indications. Not Merck KGaA. In 2009, the FDA allowed the German pharma to narrow Erbitux's indication for advanced colon cancer, changing the label to recommend the drug for treatment of EGFR-expressing tumors only in patients without a mutation in the KRAS gene.

While the move may have shrunk Erbitux's patient pool, Merck thinks better efficacy data in a narrower group can help marketing teams highlight the med's benefits. Analysts, however, aren't so sure that strategy will result in the sales boost the company's hoping for. Analysts expect the drug's peak sales for Merck to hit $1.25 billion this year before sliding to $1.1 billion by 2018.

And so far, sales expansion hasn't gone so well. Erbitux flopped in 2012 Phase III trials for adjuvant treatment after colon cancer surgery, and for stomach cancer. Merck also pulled its marketing application for a non-small cell lung cancer use in Europe--for the second time. Erbitux was developed by ImClone, which Eli Lilly ($LLY) bought in 2008. It is marketed in the U.S., Canada and Puerto Rico, by Bristol-Myers Squibb ($BMY). 

-- Carly Helfand (email | Twitter)

For more:
Merck KGaA eyes KRAS-gene focus to boost Erbitux sales
Merck yanks European app for Erbitux in lung cancer
BMS, Lilly's targeted drug Erbitux gets new FDA nod


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