Cell Therapeutics Inc. Announces Worldwide License and Co-Development Agreement for Development and Commercialization of XYOTAX(TM), an Investigational Agent for Treatment of Women with Non-small Cell Lung Cancer and Other Cancers
Monday September 18, 6:00 am ET
Deal Worth Up to $285 million Can Help Fuel Future Growth at CTI
SEATTLE, Sept. 18 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) today announced an exclusive worldwide licensing agreement with Novartis for the development and commercialization of XYOTAX(TM) (poliglumex paclitaxel), an investigational agent in Phase III for the treatment of 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. Novartis has also agreed to make a $15 million equity investment in CTI. CTI will have the option of co- detailing XYOTAX in the United States under the direction of Novartis, under an agreement to be entered into if CTI exercises the option. The closing of the transaction is subject to antitrust regulatory clearance and certain other closing conditions.
XYOTAX(TM) (Zi-o-taks) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, resulting in a new chemical entity. The investigational medicine is currently in phase III clinical trials to test whether single agent XYOTAX(TM) provides improved overall survival compared to paclitaxel in women with NSCLC and poor performance status.
The agreement also provides Novartis with an option to develop and commercialize pixantrone based on agreed terms. Pixantrone is an investigational agent designed to potentially increase anti-tumor activity and decrease the potential for cardiac toxicity associated with the currently marketed anthracyclines. If Novartis exercises its option on pixantrone under certain conditions, Novartis would pay CTI a $7.5M fee and up to $104M in registration and sales related milestones.
"This agreement brings the strength of one of the most innovative leaders in oncology to the development and commercialization of XYOTAX, an agent that 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," said James A. Bianco, M.D., President and CEO of CTI. "It also provides pixantrone with potential access to a market leader in blood related cancer therapeutics to fully maximize its commercial potential."
Bianco added: "This collaboration takes CTI one step closer to rebuilding its commercial presence in the United States and its goal of becoming a profitable cancer focused company. It also allows us to continue our growth through an acquisition strategy looking for other novel targeted agents to add to our development pipeline and into our future commercial infrastructure."
CTI had also announced in June that they have agreed on pathways for regulatory approvals for XYOTAX in recent meetings with the U.S. Food and Drug Administration (FDA) and the European Medicine Agency's Scientific Advice Working Party (SAWP). Lung cancer continues to be a major killer of men and women on both continents. In the United States, lung cancer is now the number one cancer killer of women.
The common stock to be issued to Novartis has not been registered under the Securities Act of 1933, as amended, or any state securities laws. The common stock may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state laws. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of this common stock. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful. |
