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Agensys and Merck Announce Agreement to Co-Develop and
Commercialize a Novel Antibody for Cancer Therapy
SANTA MONICA, CA and WHITEHOUSE
STATION, NJ, Oct. 17, 2005 – Agensys,
Inc., a cancer biotechnology company, and Merck & Co., Inc. today
announced that they have formed a global alliance to jointly develop and
commercialize AGS-PSCA, Agensys' fully human monoclonal antibody (MAb) to
Prostate Stem Cell Antigen (PSCA).
The agreement grants Merck worldwide
rights to AGS-PSCA and an exclusive license to PSCA,
a proprietary Agensys target, as well as rights to other therapeutic and
diagnostic products developed under the alliance. Under the terms of the agreement, Merck
will make an initial cash payment to Agensys of $17.5 million and, subject
to the achievement of certain events, further payments of $11.5 million
over the following 12 months. The
successful development and launch of AGS-PSCA would
trigger milestone payments of $95.0 million that could increase to more
than $170 million if multiple oncology indications are successfully
developed and approved. Agensys
would also receive royalties on worldwide sales. Further financial terms were not
disclosed.
"AGS-PSCA is the
first antibody product from our pipeline and developing this novel and potentially
important cancer therapy with Merck fulfills one of our major strategic
goals," said Dr. Donald B.
Rice, Chairman, President and CEO of Agensys. "In preclinical studies of human
prostate, pancreatic and bladder cancers, AGS-PSCA has
consistently demonstrated significant inhibition of tumor growth and
metastases leading to increases in survival.
"Merck's outstanding research and
clinical development capabilities, dedication to oncology, and commitment
to partnering made them a persuasive choice of co-development partner for
Agensys," Dr. Rice added.
Merck and Agensys will co-develop and
jointly fund AGS-PSCA for
prostate cancer and other indications through Phase II. Agensys has initiated a Phase I clinical
trial of AGS-PSCA in patients with advanced
prostate cancer at Memorial Sloan-Kettering Cancer Center and Johns Hopkins Kimmel Cancer Center. Agensys manufactured the clinical trial
supplies used in this study and will continue to manufacture AGS-PSCA until
production can be transferred to Merck.
Merck will lead the future worldwide clinical development program
with significant participation by Agensys.
Merck has primary responsibility for both commercialization and
commercial manufacture. Agensys has
an option to participate in Phase III development and commercialization in
the United States.
“We are excited about joining
with Agensys to develop AGS-PSCA for
prostate and other cancers, which represent major unmet medical needs that
we are hoping to address through Merck’s oncology franchise,”
said Dr. Stephen H. Friend, Executive Vice President, Advanced Technology
and Oncology, Merck Research Laboratories.
“Agensys’ innovative approaches have provided an
excellent opportunity to evaluate this important mechanism, and we look
forward to a productive alliance.”
About AGS-PSCA
AGS-PSCA is a high
affinity, fully human IgG1k MAb directed to PSCA, generated using
XenoMouse® technology. PSCA is
expressed at significant levels on tumor cells from a majority of patients
with all stages of prostate, pancreatic and bladder cancers. Efficacy studies utilizing human
specimens of these tumors in xenograft mouse models have consistently
demonstrated that AGS-PSCA
significantly inhibits both tumor growth and metastases. Pre-clinical animal toxicology and
pharmacokinetic studies have indicated that all administered doses of AGS-PSCA were well
tolerated and demonstrated a long serum half-life.
About Agensys
Agensys, Inc. is a privately held
biotechnology company that is developing a pipeline of therapeutic
monoclonal antibodies to treat solid tumor cancers. These antibodies, many of which are fully
human, are being generated to a diverse portfolio of proprietary,
clinically relevant cancer targets that encompass 14 types of solid
tumors. The Company has the
capabilities to generate, develop and manufacture and move into clinical
trials antibody products and, through a partnership with Abgenix, has
access to the XenoMouse® technology to generate fully human antibodies to
multiple targets. Agensys is
progressing a pipeline of preclinical MAb candidates with potential as
naked or payload-conjugated therapeutic products, directed at a variety of
cancer indications, including prostate, kidney, bladder, pancreas, lung,
colon, ovary, breast, and skin.
Agensys has initiated clinical trials with AGS-PSCA, a fully
human MAb to Prostate Stem Cell Antigen (PSCA), a novel target which is
expressed in the majority of prostate, pancreatic and bladder cancers. AGS-PSCA has
demonstrated significant in vivo efficacy in a variety of human xenograft
models and a benign safety profile in pre-clinical toxicology studies. In parallel to developing certain
antibody products, Agensys has established partnerships to develop and
commercialize selected antibody products and other product applications for
its proprietary targets. The
Company's laboratories, GMP manufacturing
facility and offices are located in Santa Monica, California. For further information about Agensys,
please visit http://www.agensys.com.
About Merck
Merck & Co., Inc. is a global
research-driven pharmaceutical company dedicated to putting patients
first. Established in 1891, Merck
discovers, develops, manufactures and markets vaccines and medicines in
more than 20 therapeutic categories.
The company devotes extensive efforts to increase access to
medicines through far-reaching programs that not only donate Merck
medicines but help deliver them to the people who need them. Merck also publishes unbiased health
information as a not-for-profit service.
For more information, visit www.merck.com.
Merck Forward-Looking Statement
This press release contains
"forward-looking statements" as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements involve risks and
uncertainties, which may cause results to differ materially from those set
forth in the statements. The
forward-looking statements may include statements regarding product
development, product potential or financial performance. No forward-looking statement can be
guaranteed, and actual results may differ materially from those
projected. Merck undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise. Forward-looking statements in this press
release should be evaluated together with the many uncertainties that
affect Merck's business, particularly those mentioned in the cautionary
statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004,
and in its periodic reports on Form 10-Q and Form 8-K, which the company
incorporates by reference.
Contacts
Donald B. Rice, Ph. D.
President and CEO
drice@agensys.com
Aya Jakobovits, Ph.D.
Senior Vice President and CSO
ajakobovits@agensys.com
Merck & Co.,
Inc
Press
Contact: Investor Contact:
Janet Skidmore Graeme
Bell
(908) 423-3046 (908)
423-5185
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