PIXANTRONE -- Based on preliminary results from its phase III extend trial for Pixantrone reported on November 11, 2008 and a forthcoming FDA meeting later this quarter, CTI currently plans to submit a rolling NDA filing for pixantrone with potential Q4- 2009 approval and launch in U.S. which could result in upfront and approval payment and milestones to CTI should Novartis elect to exercise their option to enter into an exclusive worldwide license to develop and commercialize pixantrone.
OPAXIO -- Potential Marketing Authorization Application approval by the European Medicines Agency or EMEA for OPAXIO for first-line treatment of patients with non-small cell lung cancer (NSCLC). If Novartis elects to commercialize OPAXIO in Europe based on EMEA acceptance of the MAA filing CTI could earn additional cash reimbursement payments and royalties on sales from OPAXIO.
Continued improvement of our capital structure through a comprehensive recapitalization plan intended to help CTI regain compliance with the Nasdaq listing standards, and which may include additional equity or debt offerings, and the reduction of our outstanding indebtedness, through the previously announced potential tender offer for a portion of our outstanding convertible notes or otherwise as disclosed on December 5, 2008.
Review of 2008 Key Accomplishments:
Entered into an agreement with Bayer Schering Pharma to gain access to its positive phase III Zevalin First-line Indolent Trial (FIT) data for submission to the FDA in connection with the Zevalin sBLA.
Successful pre-sBLA meeting with FDA and submission of sBLA for expansion
of the label for Zevalin for use in first-line consolidation treatment for
non-Hodgkin's lymphoma. FDA has granted the sBLA priority re
|SOURCE Cell Therapeutics, Inc.|
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