• 8/30/2005
  • Frankfurt, Germany
  • press release
  • Bloomberg News (bloomberg.com)

Merck KGaA, which owns non-U.S. rights to ImClone Systems Inc.’s Erbitux cancer treatment, submitted to regulators new data on the drug’s ability to treat head-and-neck cancers, aimed at boosting its sales in Europe.

It submitted its application to the European Medicines Agency and the Swiss regulator Swissmedic, the Darmstadt, Germany-based drugmaker said today in an e-mailed statement. ImClone and its marketing partner Bristol-Myers Squibb Co. have applied to the U.S. Food and Drug Administration to extend the drug’s use in the U.S.

Merck KGaA Chief Executive Bernhard Scheuble, who negotiated European rights to the drug from ImClone in 1998 for $60 million, aims to widen its use beyond colon cancer, for which it’s approved in Europe and the U.S. Merck’s sales from Erbitux came to 94 million euros ($115.5 million) during the first half of the year, compared with the 77 million euros it generated in all of 2004, its first year on the market.

Erbitux is approved for patients whose bowel cancer has spread and who aren’t benefiting from other treatments. The drug was approved in Europe and the U.S. on the basis of phase II clinical data that showed its ability to shrink tumors. Three phases of studies are generally required for regulatory approval.

Difficult to Treat

The additional sales potential from head-and-neck cancers, which are notoriously difficult to treat, is lower than for other cancer types, Groschke said in an Aug. 29 telephone interview. “This indication is significantly smaller than colon cancer,” he said.

Head-and-neck cancers are often caused by tobacco and alcohol. They occur in cells lining the mouth, nose and throat, the tongue and other parts of the head including the brain, and account for as much as 5 percent of all cancers in the U.S., according to the National Cancer Institute.

Merck KGaA, which is not affiliated to the U.S. drugmaker Merck & Co., has begun a series of late-stage studies to obtain evidence that the drug can increase chances of survival as well as shrink tumors.

The company said in June that data from a study of 21 patients showed that Erbitux helped to prolong the lives of colon cancer patients by an average 33 months, almost a year longer than patients on chemotherapy alone. It was the first data to demonstrate the drug’s ability to prolong lives.

The medicine belongs to the same class of medicines as Genentech Inc. and OSI Pharmaceutical Inc.’s lung cancer drug Tarceva.