WSJ
Drug Brings ImClone in From Cold
By RON WINSLOW
May 31, 2008
The big annual cancer confab known as ASCO is under way through Monday in Chicago, and it features a return to respectability of sorts for ImClone Systems Inc. after the company's long residency in the biotech doghouse.
ImClone's flagship drug, Erbitux, is the subject of two of the four papers selected for presentation at the American Society of Clinical Oncology's Sunday plenary session -- the showcase slots reserved for the meeting's most important new science.
That amounts to the most attention devoted to the drug at the meeting since 2001, when positive data from a colon-cancer study set Erbitux on a presumed fast track to helping launch the targeted-drug era now transforming cancer treatment.
But the Food and Drug Administration wasn't convinced, and the failure of ImClone founder Sam Waksal to forthrightly disclose the agency's misgivings resulted in an insider-trading scandal that landed both him and style-and-taste doyenne Martha Stewart in jail. Erbitux finally reached the market in 2004.
With the two plenary papers topping a list of some 80 scientific presentations about Erbitux and new drugs in ImClone's pipeline, "this is a breakthrough meeting for us," says John H. Johnson, who became ImClone's chief executive in August. It matters as well to Bristol-Myers Squibb Co., Imclone's North American marketing partner for Erbitux, and Merck KGaA of Germany, which sells the drug in Europe and which sponsored the two featured studies. Combined, the companies reported nearly $1.4 billion of Erbitux sales in 2007.
Analysts are divided about whether the high-profile science is good news for ImClone, with skeptics holding sway in advance of the meeting: its shares are off more than 11% since late April.
It is already known that in one of the featured studies, called Flex, adding Erbitux to chemotherapy improved survival as a first-line treatment for patients with advanced lung cancer. Sunday's presentation will reveal by how much. Some analysts doubt the benefit is enough for the drug to match up well against such rivals as Genentech Inc.'s Avastin. ImClone says whatever the results, half of lung-cancer patients can't take Avastin due to side effects, leaving a sizable new market for Erbitux.
The other study has broader implications. It looks at whether a genetic test will help predict which colon-cancer patients might benefit from Erbitux -- and which wouldn't. Previous smaller studies suggest that 40% of colon-cancer patients carry a mutation or biomarker that makes it unlikely they will respond to the drug. That, some analysts say, could shrink the colon-cancer market for Erbitux.
ImClone argues that therapy guided by biomarkers is the future of cancer treatment. "If you can use a biomarker to increase your probability of success, that's huge in our business," Mr. Johnson says. When drugs work, he adds, patients stay on them longer, offsetting the impact of a smaller market.
Other biomarker papers are on ASCO's agenda. The enduring news out of this meeting may be less about new drugs than about how to use current drugs better.
Write to Ron Winslow at ron.winslow@wsj.com
