NEW JERSEY, March 4, 2002:

On February 11, we published an article about Erbitux, the investigational monoclonal antibody therapy under development for the treatment of cancer. We were hoping -- for the sake of the patients the entire oncology community -- for a quick resolution to the tussle between pharmaceutical giant Bristol-Myers Squibb and biotech baby ImClone Systems.

What has come to light since that day is very surprising.

First of all, the Wall Street Journal shared our perspective about putting patients first. But the Journal went even further, offering sharp criticism of the FDA. The paper questioned whether the FDA had any intention of ever approving the drug. The agency gave Erbitux fast track status last year, so it must have known the endpoints of the proposed studies, claimed the Journal. Moreover, the WSJ also questioned whether additional Erbitux-monotherapy studies, as suggested by the FDA, were really necessary -- since the agent may never be used outside of combination therapy.

Second, last week, federal agents began to question 7 other pharmaceutical firms -- firms which passed on the opportunity to take part in the marketing of Erbitux. What these companies shared and what these federal agencies learned is anyone's guess. But wasn't this another potentially needless delay in a process to bring a potentially life saving therapy to market?

Finally, where was Merck KgaA in all this? When finally Merck KgaA finally agreed to share its EU data with ImClone, this move seemed to appease the FDA and Bristol-Myers Squibb. BMY, which had basically "bet the farm" on Erbitux -- in an attempt to preserve what's left of its oncology "franchise" -- was apparently backing down from its earlier threats to ImClone, thanks to the arrival of the Merck data.

But we wonder: why there was such a delay in the involvement of Merck KgaA? We realize the wheels of progress grind slowly. But when there are patient's lives at stake, there have to be ways to cut through red tape.

In any event, we once again look forward to the day we can report the good news -- about the progress of these revolutionary new agents like Erbitux -- news that will put new hope in the hearts of patients and their families.

Remember how excited we were about Gleevec?

Isn't that what it's all about...

Hope.

And it's why we think these agents mustn't be delayed any further.

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