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SAN FRANCISCO — Shareholders aren’t the only ones upset by ImClone Systems Inc.’s dwindling stock price and its troubles with the Food and Drug Administration and an angry corporate partner. 

Desperately ill cancer patients fear their lives are being cut short because ImClone botched its FDA application for the approval of the drug Erbitux, which had been eagerly expected for this year. 

“Many patients had hoped for this drug and there was a lot of excitement,” said cancer survivor Pamela McAllister of the Colorectal Cancer Network, a patient-support and lobbying organization. “I, too, had hope for it. Now I don’t know.” 

Erbitux is a new breed of drug, a “smart bomb” that attacks bad cells while leaving good ones alone. It’s so precisely aimed that in limited human tests, it appeared to have few side effects except for some facial acne. 

Most cancer drugs now on the market indiscriminately attack all rapidly growing tissue in the body in the hope they will kill more bad cells than good. Those chemotherapy treatments often produce severe side effects such as fatigue and nausea. 

“I certainly would have a better quality of life without the side effects,” said colorectal cancer patient Vee Kumar, a 47-year-old school psychologist in Kirkland, Wash. “It’s extremely frustrating to realize this drug isn’t available because of incomplete paperwork.” 

No doctors expected Erbitux to be a miracle cure. Still, it came highly touted because results from human tests showed promise in fighting colorectal, pancreatic and head-and-neck cancers, among others. 

The FDA last year granted the drug “fast-track” approval status for treating colorectal cancer, which kills 56,000 people a year in the United States, where about 133,000 people are diagnosed with it each year. 

Erbitux, a molecule that blocks cancer’s ability to fuel its own growth, was seen as a good, last-hope treatment for patients who proved resistant to chemotherapy. 

“The bottom line is that the drug works in some people,” said Dr. Robert Mayer, director of gastrointestinal oncology at the Dana-Farber Cancer Institute in Boston. “Many of us have been very enthusiastic about this drug.” 

The drug’s reputation grew dramatically in May, when ImClone released data at the American Society of Clinical Oncology’s annual meeting in San Francisco showing that cancer tumors shrank in 22.5 percent of the 120 patients in a clinical trial. That’s a good response for a cancer drug. 

Even before that announcement, online cancer chat rooms had been buzzing and the company’s stock skyrocketed on a steady stream of good publicity. 

Patients badgered their doctors and the company for access to the drug. 

ImClone CEO Sam Waksal told a congressional panel examining “compassionate use” of experimental, unapproved drugs last year that his company received 8,500 requests for Erbitux between May 2000 and January 2001. 

Usually, patients needing unapproved treatments are enrolled in clinical trials meant to gather data for FDA approval. Needy patients not involved in the trials can still obtain experimental drugs through “compassionate use” and “expanded access” programs allowed by the FDA. 

Waksal told the committee the company could offer compassionate use to only 30 patients because of production limitations at ImClone, a small New York City-based company. 

“We know we let people down, but we tried our best,” Waksal said. “Our feeling has been and continues to be that the best and most compassionate thing we can do now is to concentrate on getting the drug approved as expeditiously and as broadly as possible, so that all the patients in need can get this drug.” 

Waksal had hoped the drug would be approved by now. So did Bristol-Myers Squibb Co., which sealed the drug’s sterling reputation in September when it paid $1.2 billion and pledged $800 million more to partner with ImClone and share Erbitux profits. 

Since the FDA refused on Dec. 28 to even review the Erbitux application without more documentation, Bristol-Myers has had write off $735 million from the deal. 

The openly feuding partners plan to meet with the FDA next Tuesday to discuss reworking the application. But even the most bullish ImClone analysts now say Erbitux will be on the market no earlier than late 2003. 

ImClone — which faces three federal investigations and at least a dozen class-action shareholder lawsuits — also has temporarily shelved a plan to petition the FDA to give to Erbitux to more needy patients pending approval, three cancer patient advocates said. 

“We were very close to announcing the expanded access,” said patient advocate Frank Burroughs. “That’s been stopped dead in the tracks.” 

Burroughs, whose 21-year-old daughter died of head-and-neck cancer in May, was among those negotiating with ImClone late last year for expanded access to Erbitux when ImClone got its bad news. 

The advocates said ImClone executives told them they want to await next week’s meeting before resuming their efforts. 

“It’s a shame that it’s not out there,” said Fred Santino of Arlington, Mass., whose wife died in May of colorectal cancer while unsuccessfully seeking Erbitux. “Cancer is bad enough without all of this other stuff going on.” 

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On the Net: 

ImClone: http://www.imclone.com 

Colorectal Cancer Network: http://www.colorectal-cancer.net 

FDA: http://www.fda.gov