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Cell
Genesys Snags Up to $320M in Cancer-Therapy Pact with Takeda |
Summary:
Cell Genesys and Takeda have formed a global alliance for the
development and commercialization of GVAX immunotherapy for prostate
cancer, Cell Genesys lead product candidate currently in Phase
III clinical development. Takeda will pay Cell Genesys an upfront
payment of $50 million and additional milestone payments totaling up
to $270 million. See full
press release below.
March
31, 2008--Cell Genesys, Inc.
(Cell Genesys)
(Nasdaq:CEGE) and Takeda Pharmaceutical Company Limited (Takeda)
(TOKYO:4502) today announced that the companies have formed a global
alliance for the development and commercialization of GVAX
immunotherapy for prostate cancer, Cell Genesys' lead product
candidate currently in Phase 3 clinical development.
Under the agreement, in exchange for
exclusive worldwide commercial rights to GVAX immunotherapy for
prostate cancer, Takeda will pay Cell Genesys an upfront payment of
$50 million and additional milestone payments totaling up to $270
million relating to regulatory approval and commercialization of
GVAX immunotherapy for prostate cancer in the United States,
European Union and Japan. Takeda will pay Cell Genesys tiered,
double-digit royalties based on net sales of GVAX immunotherapy for
prostate cancer in the United States and flat double-digit royalties
based on net sales of the product in all other regions. From this
point forward, Takeda will pay for all external development costs
associated with the ongoing Phase 3 clinical development of GVAX
immunotherapy for prostate cancer and will also pay for all
additional development costs and all commercialization costs. Cell
Genesys will maintain responsibility for the worldwide manufacture
and supply of the product and will retain rights to co-promote GVAX
immunotherapy for prostate cancer in the United States.
We are
very pleased to have entered into this agreement with Takeda for the
development and commercialization of GVAX immunotherapy for prostate
cancer and look forward to benefiting from Takedas
impressive record of success as a global pharmaceutical business and
clear commitment to become a leader in the field of oncology,
stated Stephen A. Sherwin, M.D., chairman and chief executive
officer of Cell Genesys. In particular,
we are very glad to have the opportunity to work with the company
that pioneered the global development and commercialization of the
worlds leading prostate cancer drug,
Lupronฎ, and
hope to build on that success with GVAX immunotherapy for prostate
cancer, a potential new treatment option for men with this disease.
"We are excited to have added
GVAX immunotherapy for prostate cancer to our growing oncology
pipeline and are eager to do all that we can to ensure its
commercial success in the United States and globally,
said Yasuchika Hasegawa, president of Takeda. Our
extensive experience in the prostate cancer market, coupled with our
global infrastructure of development and marketing makes us
well-suited to work in partnership with Cell Genesys in the effort
to make GVAX immunotherapy for prostate cancer a reality for
patients in need."
GVAX immunotherapy for prostate
cancer is currently being evaluated in two Phase 3 clinical trials,
VITAL-1 and VITAL-2, in patients with advanced prostate cancer. The
U.S. Food and Drug Administration has granted Cell Genesys Fast
Track status for the GVAX prostate cancer program and both trials
have completed Special Protocol Assessment agreements. In 2007, the
VITAL-1 trial completed enrollment with 626 patients and in January
2008, Cell Genesys announced that the Independent Data Monitoring
Committee (IDMC) had completed a pre-planned interim analysis for
VITAL-1 and recommended that the study continue. The IDMC provided
no information to the company other than the recommendation to
continue the trial. The company currently estimates that there will
be sufficient events to trigger the final analysis for VITAL-1 in
the second half of 2009. Patients are continuing to be enrolled in
the VITAL-2 trial at approximately 100 clinical trial sites located
in North America and Europe. Cell Genesys is targeting the
completion of enrollment for VITAL-2 with approximately 600 patients
in the first half of 2009 and expects that there will be sufficient
events to trigger the pre-planned interim analysis in the same time
frame.
About GVAX Immunotherapy for
Prostate Cancer
Cell Genesys' GVAX cancer
immunotherapies are whole-cell products that are designed to present
the immune system with a broad spectrum of tumor antigens and
stimulate an immune response against the patient's tumor. GVAX
immunotherapy for prostate cancer is comprised of two prostate tumor
cell lines that have been modified to secrete GM-CSF
(granulocyte-macrophage colony stimulating factor), an immune
stimulatory hormone that plays a key role in stimulating the body's
immune response, and then irradiated for safety. GVAX for prostate
cancer is being developed as a non patient-specific,
"off-the-shelf" pharmaceutical product. The company is
currently manufacturing the product in its bioreactor manufacturing
facility in Hayward, California, a facility that is also capable of
producing the product for commercialization.
About Cell Genesys
Cell Genesys is focused on the
development and commercialization of novel biological therapies for
patients with cancer. The company is currently pursuing two clinical
stage product platforms GVAX
cancer immunotherapies and oncolytic virus therapies. Ongoing
clinical trials include Phase 3 trials of GVAX immunotherapy for
prostate cancer, Phase 2 trials of GVAX immunotherapies for
pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070
oncolytic virus therapy for bladder cancer. Cell Genesys continues
to hold an equity interest in its former subsidiary, Ceregene, Inc.,
which is developing gene therapies for neurodegenerative disorders.
Cell Genesys is headquartered in South San Francisco, CA and has its
principal manufacturing operation in Hayward, CA. For additional
information, please visit the companys
website at www.cellgenesys.com.
About Takeda
Located in Osaka, Japan, Takeda
(TOKYO:4502) is a research-based global company with its main focus
on pharmaceuticals. As the largest pharmaceutical company in Japan
and one of the global leaders of the industry, Takeda is committed
to striving toward better health for individuals and progress in
medicine by developing superior pharmaceutical products. Additional
information about Takeda is available through its corporate website,
www.takeda.com.
Forward-Looking Statement for Cell
Genesys
Statements made herein about the
company, other than statements of historical fact, including
statements about the expectations regarding the agreement with
Takeda, the company's progress, results, analysis, enrollment and
timing of VITAL-1 and VITAL-2 and other clinical trials and
preclinical programs and the nature of product pipelines are
forward-looking statements and are subject to a number of
uncertainties that could cause actual results to differ materially
from the statements made, including risks associated with the
success of clinical trials and research and development programs,
regulatory requirements and the regulatory approval process for
clinical trials, manufacture and commercialization of the companys
products, competitive technologies and products, patents, the need
for and reliance on partnerships with third parties and the risks
inherent in partnership with third parties, and the need for
additional financings. For information about these and other
risks which may affect Cell Genesys, please see the company's
reports on Form 10-Q, 10-K, and 8-K and other reports filed from
time to time with the Securities and Exchange Commission. The
company assumes no obligation to update the forward-looking
information in this press release.
Forward-Looking Statement for
Takeda
This press release contains
forward-looking statements regarding the Company's plans, outlook,
strategies and results for the future. All forward-looking
statements are based on judgments derived from the information
available to the Company at this time.
Certain risks and uncertainties
could cause the Company's actual results to differ materially from
any projections presented in this press release. These risks
and uncertainties include, but are not limited to, the economic
circumstances surrounding the Company's business; competitive
pressure; relative laws and regulations; product development
programs; and changes in exchange rates.
We assume no obligation to update
or reverse any forward-looking statements or other information
contained in this press release, whether as a result of new
information, future events, or otherwise.
Contacts
Cell
Genesys
Susan Ferris, 650-266-3200
Investor Relations
IR@cellgenesys.com
or
Takeda
Seizo Masuda, +81-3-3278-2037
Media/Investor Relations
Masuda_Seizo@takeda.co.jp

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