SEATTLE, Jan. 14 /PRNewswire-FirstCall/ -- In meetings held in association with the JP Morgan Healthcare Conference in San Francisco, Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) reviewed 2009 targeted milestones and 2008 accomplishments. CTI is seeking to obtain two new drug approvals in 2009 in addition to potential label expansion for Zevalin(R). In November CTI established a 50/50 joint venture with Spectrum Pharmaceuticals, Inc. (Spectrum) for Zevalin.
"With a focus on cutting-edge oncology drug products, CTI aims to complete its transition from a research-based organization to a leading commercial oncology company," said James A. Bianco, M.D., CEO of Cell Therapeutics. "In 2008 we set the stage for becoming a multi-product commercial oncology operating company, with Zevalin currently under priority review by the FDA in the U.S. for label expansion, OPAXIO(TM) under review for market authorization application approval in Europe and, based on positive Phase III data for pixantrone, we expect to file a rolling NDA in 2009. Additionally, we continue to focus on improving our capital structure, streamlining our operations and significantly reducing our cash burn rate. With potential approval of pixantrone and OPAXIO in 2009, and potential sales revenue growth due to possible Zevalin label expansion, we are on target to accomplish our goal of reaching cashflow break-even in the fourth quarter of 2009," Bianco added.
Targeted 2009 Milestones:
ZEVALIN -- First- line consolidation indication approval for Zevalin with
a target decision date by the FDA of April 2, 2009, based on a supplemental
biologics license application (sBLA) submitted on October 2, 2008 for the use
of Zevalin as consolidation therapy after remission induction in previously
untreated patients with follicular non-Hodgkin's lymphoma. CTI and Spectrum
have a joint venture for the sales, marketing and development of Z
|SOURCE Cell Therapeutics, Inc.|
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