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Press Release Source: Cell Therapeutics, Inc.
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.
ADVERTISEMENT
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.
About XYOTAX
XYOTAX(TM) (paclitaxel poliglumex) is a biologically-enhanced
chemotherapeutic that links paclitaxel, the active ingredient in
Taxol®, to a biodegradable polyglutamate polymer, which results in
a new chemical entity. When bound to the polymer, the chemotherapy
is rendered inactive, potentially sparing normal tissue's exposure
to high levels of unbound, active chemotherapy and its associated
toxicities. 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
distributed to tumors due to their leaky blood vessels and trapped
in the tumor bed allowing significantly more of the dose of
chemotherapy to localize in the tumor than with standard
paclitaxel. Once inside the tumor cell, enzymes metabolize the
protein polymer, releasing the paclitaxel chemotherapy. Preclinical
and clinical studies support that XYOTAX metabolism by lung cancer
cells may be influenced by estrogen, which could lead to enhanced
release of paclitaxel and efficacy in women with lung cancer
compared to standard therapies.
About Pixantrone
Pixantrone is an investigational agent under development for the
potential treatment of various hematological malignancies, solid
tumors and immunological disorders. It was developed to improve the
activity and safety of the anthracycline family of anti-cancer
agents. Anthracyclines have been shown to be very active clinically
in a number of tumor types. However, they are usually associated
with cumulative heart damage that prevents them from being used in
a large proportion of patients. Pixantrone has been designed to
reduce the potential for these severe cardiotoxicities, as well as
to potentially increase activity and simplified administration
compared to the currently marketed anthracyclines.
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.
Conference Call
A conference call will be held on September 18, 2006 at 8:30 am
(ET) to discuss the agreement. The domestic call-in number is
1-800-240-7305 and the international number is 1-303-205-0033. The
call will be webcast live and archived after the call for replay
and may include forward-looking information.
This press release includes and the conference call may include
forward- looking statements that involve a number of risks and
uncertainties, the outcome of which could materially and/or
adversely affect actual future results. These forward looking
statements include statements regarding the conditions to
effectiveness of the agreements being satisfied, the achievement of
any product registration and sales milestones under the agreement
and the amount of any such milestones, the development and
commercialization of XYOTAX and pixantrone and CTI's future
operations and plans. The risks and uncertainties that could affect
the achievement or amount of any product registration and sales
milestones include risks associated with Novartis choosing to
exercise its rights under the license agreement, the achievement of
the product and sales milestones set forth in the license agreement
and Novartis' ability to terminate the license agreement. The risks
and uncertainties that could affect the development of XYOTAX and
pixantrone include risks associated with preclinical and clinical
developments in the biopharmaceutical industry in general and with
XYOTAX and pixantrone in particular including, without limitation,
the potential failure of XYOTAX to prove safe and effective for
treatment of lung and ovarian cancers and pixantrone to prove safe
and effective for treatment of non-Hodgkin's lymphoma,
determinations by regulatory, patent and administrative
governmental authorities, competitive factors, technological
developments, costs of developing, producing and selling XYOTAX and
pixantrone, and the risk factors listed or described from time to
time in CTI's filings with the Securities and Exchange Commission
including, without limitation, CTI's most recent filings on Forms
10-K, 8-K, 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.
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