European Regulatory Agency Supports Opaxio Brand Name for Cell Therapeutics' Lung Cancer Drug

Cell Therapeutics, Inc. (CTI) today announced that it received a positive opinion from the European Medicines Agency (EMEA) for the brand name Opaxio(TM) (paclitaxel poliglumex), which replaces Xyotax(TM) as the brand name.

"We are pleased the EMEA has provided a favorable review of the OPAXIO brand name, which tested well in market research. This is a key step toward commercialization as we prepare for the potential introduction of this novel biologically enhanced chemotherapeutic in Europe, to establish OPAXIO as the global brand name for paclitaxel poliglumex," noted Jim Fong, Vice President of Commercial Operations at CTI.

In April, the EMEA accepted for review CTI's Marketing Authorization Application (MAA) for OPAXIO (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The EMEA's review process generally takes 15 to 18 months; if the MAA is approved by the EMEA at the end of its review, CTI will be authorized to begin selling OPAXIO in the European Union.

Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.