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German drug maker
released long-awaited study results today for the experimental cancer drug Erbitux, showing that the drug, when combined with chemotherapy, shrank tumors in patients with late-stage colon cancer. Furthermore, the two-drug combination was more effective than when Erbitux was used alone in the patients, all of who were no longer responding to chemotherapy.
The findings were presented at the annual meeting of the American Society of Clinical Oncology.
The actual data from the Merck study is an almost exact repeat of data previously gathered by
back in 2001. The legitimacy of the earlier ImClone data -- and the way it was gathered -- was called into question by the Food and Drug Administration, which rejected ImClone's original application for Erbitux in December 2001. And as everyone remembers, this setback sent ImClone's shares tumbling, ensnaring former CEO Sam Waksal in insider trading and fraud charges that are likely to send him to jail soon.
Merck -- ImClone's European partner for Erbitux -- said Sunday that the combination of Erbitux and irinotecan shrank tumors in 22.9% of patients, compared to 10.8% of those who took Erbitux alone. The study enrolled 329 colon cancer patients whose disease was progressing after failing to respond to irinotecan. Two-thirds of the patients in the study received the combination regimen, one-third received Erbitux alone.
These numbers are very close to the ones I
reported back in May.
Recall, during the ASCO meeting of 2001, ImClone said 22.5% of colon cancer patients in similar straits receiving the Erbitux-chemo combination saw their tumors shrink. Subsequently, a small study using Erbitux alone, also sponsored by ImClone, found a tumor response rate of about 10%.
Erbitux is an engineered monoclonal antibody given by injection and a member of the closely watched class of drugs that attempts to halt the growth of cancer cells by blocking a key enzyme, epidermal growth factor receptor.
lung cancer drug, Iressa, was the first of these so-called EGFR inhibitors to be approved in the U.S. earlier this year. Biotech teams comprised of Abgenix and Amgen, and Genentech and OSI Pharmaceuticals, are working on similar drugs.
Merck has already announced plans to use this Erbitux data to seek regulatory approval for the drug in Europe this summer. Expectations are for the drug to be approved there by 2004.
The plans for ImClone and its U.S. partner
are not yet as clear. Neither company has divulged its timetable for getting Erbitux back to the FDA. But the companies might use the Merck data, combined with revised data from their original application, to refile later this year, possibly as early as this summer. That could get Erbitux approved in the U.S. by early next year, if not sooner, given the approve-drugs-faster attitude adopted by the new FDA hierarchy.
ImClone shares closed Friday at $28.50, just off a 52-week high reached intraday, as investors anticipated the results released today. ImClone shares have jumped 160% since the beginning of the year.
In other Merck-sponsored findings released today from its study, patients taking the combination of Erbitux and irinotecan showed no tumor progression for a median of 4.1 months, compared to 1.5 months for patients receiving Erbitux alone. The one-year survival rates for both groups was about 30%.
Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send