Press accounts suggest filing in 3Q02
NEW YORK (Reuters) - As Bristol-Myers Squibb Co. and partner ImClone Systems feud following a dramatic U.S. regulatory setback for their cancer drug Erbitux, German drugmaker Merck KGaA remains boldly confident of winning European approval for the same drug next year.
``The fight between Bristol-Myers and ImClone is none of our business. But we have done our own separate clinical trials of Erbitux in Europe and strongly believe the drug will succeed here and other parts of the world,'' Hartmut Vennen, a spokesman for Germany's third-largest drug company, said in an interview.
Merck expects to seek European approval for Erbitux in the third quarter of 2002, based on promising results from late-stage trials in colon cancer, and is hopeful it will be cleared for sale a year later, Vennen said.
Merck in 1998 agreed to pay ImClone $60 million for exclusive rights to sell Erbitux, then an obscure medicine with the code-name C225, in all global markets except North America. Profits are to be split in Japan.
As the initial developer of Erbitux, ImClone kept the right to all profits in Canada and the United States, the world's most lucrative market for pharmaceuticals. Both companies then set out to design and conduct their own separate trials of the drug for colon and head-and-neck cancer, with plans to independently seek approvals in their respective territories.
Promising U.S. data from ImClone's colorectal cancer trials later rolled in, stirring excitement among oncologists and Wall Street investors. Waking up to the commercial possibilities, New York-based Bristol-Meyers agreed in September to pay ImClone up to $2 billion for just 40 percent of future U.S. Erbitux profits.
But Bristol-Myers' infatuation with ImClone soured three months later when the FDA refused to accept ImClone's marketing application because of insufficient clinical data. What's more, ImClone said the FDA might require new trials.
Such new trials could delay the U.S. launch until 2004, two years later than original plans, seriously postponing the return on Bristol-Myers' investment. |
