Cell Therapeutics (CTI) and Novartis inked an exclusive worldwide licensing agreement for the development and commercialization of Xyotax™ (poliglumex paclitaxel), an investigational agent for non-small-cell-lung cancer (NSCLC) and other cancers.
Total product registration and sales milestones for Xyotax under the agreement could reach as much as $270 million. CTI will have the option of co-detailing Xytoax in the U.S. under the direction of Novartis. Novartis also agreed to make a $15-million equity investment in CTI.
Xyotax is currently in Phase III trials to test whether single agent Xyotax improves overall survival compared to paclitaxel in women with NSCLC and poor performance status. It is a biologically enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer. Tumor tissue blood vessels are more porous than those in normal tissue to molecules like polyglutamate. Preclinical studies have shown that Xyotax is thus preferentially distributed to tumors, delivering significantly more of the dose of chemotherapy to the tumor than with standard paclitaxel. Hence, normal tissues could also be spared exposure to high levels of unbound, active chemotherapy.
Additionally, preclinical and clinical studies observed that Xyotax metabolism by lung cancer cells is influenced by estrogen. Xyotax could be demonstrated in ongoing trials to prolong survival in women with lung cancer and potentially become the first gender-specific therapy for this disease, says James A. Bianco, M.D., president and CEO of CTI.
The agreement also provides Novartis with an option to develop and commercialize pixantrone. Pixantrone is an investigational agent designed to increase antitumor activity and decrease the potential for cardiac toxicity associated with the currently marketed anthracyclines. If Novartis exercises its option on pixantrone, the company would pay CTI $7.5 million and up to $104 million in registration- and sales-related milestones.