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An Inquiry into the ImClone Cancer-Drug Story
Subcommittee on Oversight and Investigations
Dr. Harlan Waksal
Chairman Greenwood, Congressman Deutsch and Members of the Subcommittee, my name is Harlan Waksal, and I am the President and Chief Executive Officer of ImClone Systems. I have held that position for only three weeks, but I have been with the company since it was founded, 17 years ago. Thank you for this opportunity to tell you about Erbitux - a potential new treatment for cancer that attaches itself to growth factor receptors on cancer cells, depriving tumors of the ability to grow. Since we acquired the license for this compound nine years ago, ImClone has invested hundreds of millions of dollars to support its clinical program of research and testing. Our efforts reached a critical point two years ago. Over the course of the year 2000, doctors at preeminent research institutes such as the Memorial Sloan-Kettering Cancer Center reported success in using Erbitux in combination with chemotherapy to treat terminally ill patients. These doctors - and their patients - were telling us that the Erbitux combination therapy was shrinking solid tumors in patients who did not have other treatment options. As a result, we set out to make this drug available to cancer patients as quickly as possible. As this Subcommittee knows, Congress created the "Fast Track" process to encourage the expedited review of drug applications where the drug in question has the potential to address an unmet medical need related to a life-threatening illness. If ever a drug was a good candidate for "Fast Track," Erbitux was it. And in fact, the FDA granted Erbitux "Fast Track" status in January 2001. During this same period, we had multiple meetings and conversations with the FDA, to determine whether the clinical trial we had underway for colorectal cancer patients - giving Erbitux and chemotherapy in combination to patients who had failed chemotherapy alone -- could serve as the basis for regulatory approval. After the FDA reviewed our test protocol, we reached an understanding with the agency that this clinical study could be the pivotal study for our application to win approval for Erbitux. Over the next few months, we worked closely with the FDA to develop an application for approval. When the FDA asked questions, we answered them. When the FDA asked for more data, we got it for them. Such give and take is a common part of the application process. We were very pleased with the results of the clinical trial. It found that roughly 20 percent of patients responded to the treatment. These results were reported by independent physicians at preeminent cancer centers - doctors without any stake in the outcome, who saw this drug at work, first hand, in their patients. These conclusions were then confirmed by an independent review committee, commonly known as an "IRAC." The approximately 20% response rate was an impressive result, since the FDA had approved irinotecan - a chemotherapy drug - with a 13% response rate in a similar patient population. But we were not the only people excited by the potential of Erbitux. In May of 2001, doctors at the leading oncology conference - after hearing a presentation from Dr. Leonard Saltz regarding the clinical trial - reacted enthusiastically to the data. And in September of last year, after months of extensive due diligence by their top scientists, Bristol-Myers Squibb committed to investing $2 billion in ImClone and Erbitux -- a huge vote of confidence from the world's leading oncology pharmaceutical company, which clearly believed that Erbitux showed great potential. As the Subcommittee knows, despite these encouraging signs, the FDA refused to file ImClone's application for Erbitux. Today's hearing will be filled with questions as to why the FDA refused to file our application, which I am happy to answer. But in brief, let me say that with the benefit of 20/20 hindsight, we now know that we could and should have done a better job in putting together our application package. Many of our critics have suggested that our pivotal trial was too small, and that our results were not proven by the most rigorous testing standards. But, I would remind those critics that Congress explicitly created Fast Track to bring drugs to market that had not been through the rigors of a Phase III test - wisely deciding that when patients are dying, and there is a drug that demonstrates "potential" for treating those patients, the balance should be struck toward getting new drugs to those patients quickly. Notwithstanding our setbacks, ImClone and its partners continue to work closely with the FDA to move forward in the approval process. Today, Erbitux remains on the FDA's "Fast Track." We will be submitting new data as it comes in, and still hope to win accelerated approval. We also have underway a variety of other clinical tests, including large, Phase III trials. Mr. Chairman, in conclusion, I would like to make two points. First, while we had the right intentions in trying to get Erbitux through the filing process in 2001, we failed. Yes, setbacks in the regulatory process are common, and ImClone is hardly alone among drug companies in failing to win swift approval for a drug. But that does not change the fact that we let patients down, and for that, I am truly sorry. Second, as ImClone's new CEO, I am committed - absolutely committed - to getting this drug approved. I will work closely with patients and the advocacy community to see this through. And I will also work closely with the FDA, to continue the open and cooperative relationship we have had with the agency. We want to get them the information they need, as quickly as we can, so that hopefully Erbitux can be available to cancer patients in desperate need of more treatment options. I appreciate the opportunity to be here today, and will be glad to answer your questions now.
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