Washington Editor

Despite Celgene Corp.'s low expectations regarding Revlimid's ability as a monotherapy in the difficult indication of metastatic malignant melanoma patients who already had failed two lines of therapy, the firm's stock dipped on stopping a Phase III trial in that indication.

Celgene's stock (NASDAQ:CELG) fell 11.1 percent Wednesday, or $6.46, to close at $51.78. The trial in question was a pivotal study that enrolled 560 to 570 patients. Celgene halted it based on the verbal recommendation from the Data Monitoring Committee, which un-blinded the trial and found interim data that suggested Revlimid would not demonstrate a statistically significant treatment effect, the company said.

Brian Gill, Celgene's director of investor relations and public relations, told BioWorld Today it is unclear when final data will be ready for publication.

Revlimid (formerly Revimid, or CC-5013) is a derivative of the firm's flagship commercial product, Thalomid (thalidomide), an approved treatment for cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) in leprosy and for maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence.

Like Thalomid, Revlimid is believed to have an impact on other cancers, leading company officials to evaluate it in a number of indications. The firm decided to pursue metastatic malignant melanoma after a UK-based Phase I trial suggested an opportunity in the disease, Gill said, adding that Celgene had always "managed expectations down" in the indication. Meanwhile, Celgene continues to have high hopes for the drug, which is expected to make it to market in at least one indication by late 2005, Gill said. The company is sponsoring a Phase III program evaluating Revlimid in combination with chemotherapy in multiple myeloma patients. The program includes a 302-patient trial in both the UK and U.S.

Celgene expects the Phase III program to be fully enrolled by early June. The primary endpoints are time to tumor progression and overall survival in the double-blinded studies. Beyond the Phase III, Revlimid is the subject of three accelerated Phase II studies in multiple myeloma, myelodysplastic syndromes (MDS) and a subset of MDS. The targeted enrollment in each of those trials has been met.

Additional guidance on the MDS studies is expected in the third quarter while guidance on the myeloma trial should be ready in the fourth quarter. If data from the Phase II trials are compelling and approvable, Gill said it's possible that Revlimid could make it to market prior to the late 2005 guidance.