PHARMACEUTICALS ImClone will again seek approval for cancer-fighting drug Erbitux

Some cancer specialists questioned the value of a new study.
CHICAGO (AP) -- The fortunes of Erbitux, the experimental medicine that brought down the head of ImClone and ensnarled Martha Stewart in a Wall Street scandal, got a boost Sunday from a new study that concluded it helps terminally ill victims of colon cancer.
The new research, conducted in Europe, found that nearly a quarter of patients improved temporarily when they got Erbitux along with standard chemotherapy. The result mirrors the finding of an earlier study sponsored by Imclone Systems.
Because of shortcomings in that earlier study, the Food and Drug Administration refused to accept ImClone's application for approval of the drug. That decision in December 2001 triggered an insider trading scandal.
"For those who were skeptical about Erbitux, perhaps influenced by all the financial shenanigans, this clearly shows that the drug is active," said Dr. Robert Mayer, head of gastrointestinal cancer at Boston's Dana-Farber Cancer Institute, who was not involved in the study.
Some other cancer specialists, however, said they found the latest study confusing and questioned whether it truly shows the drug's worth.
Whether ImClone now has enough scientific ammunition to push Erbitux onto the market remains to be seen, but spokesman Davit Pitts said they will ask the FDA's opinion on the latest data.
European approval
The sponsor of the new study, the German pharmaceutical firm Merck KGaA, said it will soon seek European approval to sell the drug and could have it on the market there by the end of the year. The company, which owns rights to Erbitux outside North America, is unrelated to the larger U.S.-based Merck & amp; Co.
The new study was directed by Dr. David Cunningham of Royal Marsden Hospital in England, who presented the findings Sunday at a meeting in Chicago of the American Society of Clinical Oncology.