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Bristol Seeks Merck Data on Cancer Drug

By Ransdell Pierson

NEW YORK (Reuters) - Bristol-Myers Squibb Co. said it has asked German drug maker Merck KGaA to share its clinical data on experimental cancer drug Erbitux, but declined to say whether it aims to use the European data to bolster Bristol's own uncertain chances of winning U.S. approval for the medicine.

Erbitux is being developed in the United States by tiny New York biotech firm ImClone Systems Inc. (NasdaqNM:IMCL - news) and its partner Bristol-Myers (NYSE:BMY - news), whose relationship has soured since U.S. regulators in December refused to accept ImClone's marketing application for the promising medicine.

Bristol-Myers recently demanded it be given primary responsibility to negotiate the marketing application with the FDA, following ImClone's failure. ImClone rejected the demand.

``We have reached out to Merck and have told them we are interested in getting access to their data on the trials they are doing. It's very useful data to have,' Bristol-Myers spokesman Wilson Grabill told Reuters.

ImClone said Bristol-Myers had not informed the company about its request for the Merck data, nor how Bristol-Myers intends to use it. Bristol-Myers declined to elaborate on their action.

``I wouldn't want to speculate how we would use the (Merck) data,' said Grabill, whose firm is entitled to 40 percent of U.S. profits from Erbitux if it is approved by the FDA. ImClone would keep the remaining 60 percent under their $2 billion co-marketing deal announced last September.

An ImClone spokesman dismissed speculation by one industry analyst that Merck would likely demand royalties from ImClone and Bristol-Myers if they were to use Merck's clinical data for their U.S. marketing application for Erbitux.

ImClone said a provision in its contract requires both ImClone and Merck to provide their respective clinical data to each other for regulatory submission without charge.

``ImClone has all this already, and as ImClone's partner, so has Bristol-Myers,' he said. ``There's no reason for them to get it separately.'

Richard Evans, a Sanford Bernstein drug analyst, said earlier that Merck would no doubt want to be paid handsomely for sharing its data with Bristol-Myers and ImClone, possibly to the tune of hundreds of millions of dollars.

``Merck would definitely want royalties on U.S. Erbitux sales. They'd want to be paid either a sizable fixed fee or a smaller fee plus a percentage of Erbitux revenues,' Evans said.

Merck (quote from Yahoo! UK & Ireland: MRCG.F), which is not related to U.S. drug giant Merck & Co. (NYSE:MRK - news), agreed in 1998 to pay ImClone $60 million for the exclusive rights to sell Erbitux in all global markets, except North America. Profits are to be split in Japan.

ImClone and Merck then designed and conducted their own separate trials of the drug for colon and head-and-neck cancer.

But while ImClone's colon cancer trial was scorned by the FDA, Merck said its own studies have gone so well it expects to win European approval of Erbitux next year.

A source familiar with the U.S. clinical trials said Bristol-Myers apparently hopes it and ImClone can submit Merck's European data to the FDA to get Erbitux approved in the United States if the FDA continues to reject ImClone's own U.S. data.

``The Merck data is Bristol-Myers' backup plan. Their main plan is to see if the FDA will go ahead and accept ImClone's data. But if that fails, they could present the Merck data to the FDA and ask if it meets the FDA's standards for approval,' the source said.

Officials from the FDA and Merck could not immediately be reached for comment.

The FDA usually requires two well-controlled clinical trials before it will approve new medicines, but is typically willing to accept only one such trial for cancer drugs.

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