Cell Genesys and Takeda Announce Global Alliance for the Development and Commercialization...

Cell Genesys and Takeda Announce Global Alliance for the Development and Commercialization of GVAX Immunotherapy for Prostate Cancer

SOUTH SAN FRANCISCO, Calif. & OSAKA, Japan--(Business Wire)--
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 Takeda's
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 world's leading prostate cancer drug,
Lupron(R), 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(TM)
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 company's 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 company's 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.

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

Copyright Business Wire 2008