Washington Editor

ImClone Systems Inc. released a rather tame statement Friday saying it was pleased about news out of Germany that partner Merck KGaA believes the cancer drug Erbitux is on track for regulatory filing in Europe in mid-2003.

Specifically, Merck, of Darmstadt, Germany, released a brief statement saying, "Following an external review of data from its European pivotal clinical trial of Erbitux (cetuximab, C225), the company continues to be confident that the drug meets regulatory requirements for application to the European Agency for the Evaluation of Medicinal Products."

The statement said European approval is expected in 2004 (European reviews generally take 12 to 14 months).

Merck spokeswoman Phyllis Carter told BioWorld Today the company would not release details of the trial until the meeting of the American Society of Clinical Oncology June 1 in Chicago.

But the mere hint of good news pushed ImClone's stock (NASDAQ:IMCL) up 98 cents Friday to close at $18.36.

David Pitts, spokesman for ImClone, of New York, read BioWorld Today a prepared company statement saying, "We are pleased that Merck KGaA remains optimistic about meeting its European regulatory requirements for an Erbitux marketing application in mid-2003 and we look forward to supporting them in these efforts."

Meanwhile, a spokeswoman from Bristol-Myers Squibb Co., ImClone's U.S. partner, told BioWorld Today the company did not plan to comment on the announcement.

Reviewed in Europe by an independent radiologic assessment committee, Merck's Phase II trial of 330 patients with irinotecan-refractory colorectal cancer has been watched carefully by ImClone and BMS. The trial's design has been criticized because patients in the control arm received Erbitux. (See BioWorld Today, Nov. 4, 2002.)

Erbitux is a monoclonal antibody designed to target and block the epidermal growth factor receptor. The receptor is expressed on the surface of certain cancer cells in multiple tumor types.

After the FDA rejected the Erbitux rolling biologics license application (BLA) in December 2001, ImClone and BMS scrambled to solve problems with the application amid a scandal surrounding business practices of ImClone's former CEO, Samuel Waksal, who resigned his position. Harlan Waksal, Samuel's brother, is the current CEO. (See BioWorld Today, Feb. 28, 2002; Jan. 27, 2002; and Jan. 3, 2002.)

At one point, ImClone was hoping Merck would alter its Phase II trial to help ImClone's case, but the Germany-based company rejected that proposal. (See BioWorld Today, May 17, 2002.)

Subsequently, ImClone and BMS submitted two protocols to the FDA for randomized Phase III trials for second-line metastatic colorectal cancer. On Friday, Pitts characterized the Phase III studies as "pending."

Also, Pitts said a Phase II single-arm study remains "open," with data expected later this year.

Pitts would not release any information about ImClone's plan to refile its BLA.

Meanwhile, Samuel Waksal, who pleaded guilty to certain insider trading-related criminal charges, will be sentenced May 29. Waksal signed a deal on civil charges, agreeing to never work as an officer in a public company and to pay an $800,000 fine.