XYOTAX Patent Allowance Provides Exclusivity in Japan Until 2018
Patent Broadens Global Market Potential for XYOTAX
SEATTLE, Oct. 10 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced that it has received notification from the Japanese Patent Office that patent coverage extending to XYOTAX(TM) (paclitaxel poliglumex) is allowable in Japan. CTI has an exclusive license to this Japanese patent property. The patent, when issued, will provide patent protection for XYOTAX in Japan until 2018. In addition to this licensed patent property in Japan, CTI has licensed issued patents in the United States and allowed coverage in Europe that encompass XYOTAX.
"This event helps to solidify our development efforts in Japan in coordination with our partner, Chugai," stated James A. Bianco, M.D., President and CEO of CTI. "This patent will complement CTI's existing licensed patent portfolio, extending XYOTAX's exclusivity to the Japanese market. This is an important step toward securing the global market potential of XYOTAX as we move forward with the approval process."
Currently, CTI plans to submit a New Drug Application (NDA) and seek approval for XYOTAX as first-line monotherapy for women with advanced non- small cell lung cancer (NSCLC) who have poor performance status (PS2). The filing in Europe will also seek use as monotherapy in first-line PS2 patients with NSCLC, but is not expected to be limited to women; however, additional input on the statistical interpretation of non-inferiority will be needed from the scientific committee of the European Medicines Agency (EMEA) prior to submitting a Marketing Authorization Application (MAA).
About XYOTAX
XYOTAX (paclitaxel poliglumex) is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit
www.cticseattle.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of CTI's products under development include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with CTI's products under development in particular including, without limitation, the potential failure of all compounds to prove safe and effective for treatment of disease, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling CTI's products under development, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, S-3 and 10-Q. CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
SOURCE Cell Therapeutics, Inc.
