North American net sales of Erbitux (cetuximab) rose 17 percent to $187.5 million in the first quarter on positive clinical data and increased promotional efforts with co-marketing partner Bristol-Myers Squibb, ImClone reported April 24.

"Our significant commercial efforts have established Erbitux as a standard of care in refractory colorectal cancer," ImClone Senior VP-Clinical Operations Michael Bailey said during a same-day earnings call.

The company will "continue to leverage strong Erbitux clinical evidence to expand our markets with supplemental regulatory approvals," he added.

The firm plans to submit two sBLAs this year for Erbitux: one for first-line head and neck cancer in mid-year and another for first-line non-small cell lung cancer in the fourth quarter.

In June, ImClone is set to present data from its Phase III FLEX trial, which will support the lung cancer sBLA, at the American Society of Clinical Oncology annual meeting.

In 2007, the firm reported that FLEX met its primary endpoint of increasing overall survival compared with chemotherapy alone. ImClone will seek approval of Erbitux in combination with platinum-based chemotherapy in NSCLC.

Another study of Erbitux in lung cancer, BMS-099, did not meet its primary endpoint of progression-free survival last year; however, there is speculation regarding a possible survival benefit. ImClone and Bristol will report overall survival data later in 2008.

ImClone will also present the results of its Phase III CRYSTAL trial in first-line colorectal cancer at ASCO. The firm announced the study met its primary endpoint of progression-free survival in 2007.

The company has submitted voluntary genomic data to FDA in hopes of paving a clearer path to review; the firm anticipates a pre-sBLA meeting with the agency on the colorectal cancer indication in the second half of the year.

However, ImClone is not taking a stance of over-confidence on the potential for that indication. "It should be emphasized that the overall regulatory dynamics in the first-line metastatic colorectal cancer setting are complex," Chief Medical Officer Eric Rowinsky noted.

After a year of sales in 2007 characterized by some analysts as "flat," Erbitux seems to be rebounding. Global net revenues in the first quarter jumped 36 percent over the prior year period to $417.3 million.

ImClone recorded royalty revenues of $95 million, up 24 percent, comprising 39 percent of Bristol's Erbitux net sales of $187.5 million and 9.5 percent of international partner Merck KGaA's net sales of $229.8 million. Bristol also reported first-quarter results April 24 (¹ Also see "Lilly’s Prasugrel No Match For Clots Compared To Plavix, Bristol Says" - Pink Sheet, 24 April, 2008.).

ImClone reported a net loss of $55.9 million compared to the first quarter of 2007, in which it recorded net income of $28.8 million. The company recorded a net loss of $19.9 million for the fourth quarter of 2007, which included a $60 million charge related to settlement of Erbitux patent litigation with Yeda and Sanofi-Aventis (² Also see "ImClone, Sanofi-Aventis Settle Erbitux Patent Dispute" - Pink Sheet, 7 December, 2007.).

In addition to its emphasis on growing Erbitux, its only marketed product, ImClone has been working on growing its proprietary pipeline. The company announced April 22 it is moving anti-vascular endothelial growth factor receptor-2 monoclonal antibody IMC-1121B into Phase III for breast cancer (³ Also see "ImClone Metastatic Breast Cancer Candidate Moves Into Phase III In Third Quarter" - Pink Sheet, 22 April, 2008.).

Also in April, the company began a Phase II trial of anti-insulin-like growth factor-1 receptor IMC-A12 in head and neck cancer. ImClone additionally is enrolling patients in Phase II prostate and colorectal cancer trials.

-Brooke McManus (b.mcmanus@elsevier.com)

North American Erbitux Sales Up 17 Percent In First Quarter

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