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Abraxane meets pancreatic OS endpoint

November 10, 2012 1:54 AM UTC

Celgene Corp. (NASDAQ:CELG) reported late Friday that Abraxane nab-paclitaxel met the primary endpoint of overall survival (OS) vs. gemcitabine alone in the Phase III MPACT trial to treat metastatic pancreatic cancer in treatment-naïve patients. The Abraxis BioScience Inc. contingent value right (CVR), which trades on NASDAQ under the ticker CELGZ, jumped $2.89 (93%) to $6 in early after-hours trading on the data. Abraxis shareholders are eligible for $300 million ($7.41 per CVR) for FDA approval of Abraxane for pancreatic cancer with an OS claim on the label, and for $100 million ($2.47 per CVR) if FDA approval for pancreatic cancer is achieved before April 1, 2013. The CVRs opened at $6 on Oct. 18, 2010. Celgene acquired Abraxis in 2010 for about $2.9 billion plus the CVR. The CVR was up $0.04 to $3.11 on Friday.

The open-label, international MPACT trial enrolled 861 patients. Celgene said the data have been submitted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco in January. Based on the data, Celgene plans to submit regulatory applications in the U.S., EU and other markets for Abraxane to treat metastatic pancreatic cancer, with an sNDA submission to FDA planned for 2013. ...