Kyowa Hakko and Amgen Enter Licensing Agreement for Anti-CCR4 Humanized Monoclonal...

Kyowa Hakko and Amgen Enter Licensing Agreement for Anti-CCR4 Humanized Monoclonal Antibody

KW-0761 Studies Underway in Inflammation and Oncology
THOUSAND OAKS, Calif. & TOKYO--(Business Wire)--
Kyowa Hakko Kogyo Co., Ltd (Kyowa Hakko) (TSE: 4151) and Amgen
(NASDAQ: AMGN) today announced an agreement under which Amgen will
receive an exclusive license to develop and commercialize Kyowa
Hakko's humanized monoclonal antibody KW-0761 worldwide, except in
Japan, Korea, China and Taiwan. Kyowa Hakko will retain the
development and commercialization rights in these countries.

Under the terms of the deal, Amgen will make an upfront payment to
Kyowa Hakko of $100 million. Kyowa Hakko could receive up to $420
million in additional payments, including development, approval and
sales milestones. Kyowa Hakko will also be entitled to receive double
digit royalties on sales.

KW-0761 is currently being studied in inflammation and oncology
settings. Kyowa Hakko has completed Phase 1 studies of KW-0761 in
healthy volunteers and allergic rhinitis patients, and is currently
conducting Phase 1 studies of KW-0761 in lymphoma patients.

Amgen will initially acquire rights in all non-oncology
indications, and Kyowa Hakko will continue its development activities
in oncology until the completion of Phase 2a. At that time, Amgen may
elect to reimburse Kyowa Hakko for its oncology-related development
costs, expand its license to include oncology and assume the
development and commercialization of KW-0761 in oncology settings.

The agreement is subject to approval from the Federal Trade
Commission and will be effective immediately upon such approval.

Financial guidance previously provided on Jan. 24, 2008 by Amgen
for 2008 adjusted earnings per share will remain unchanged by this
transaction.

About CCR4 and KW-0761

CCR4 is a chemokine receptor that binds specifically to its
ligands TARC and MDC, and participates in the control of T cell
migration. CCR4 is expressed mainly on Th2-type helper T cells and
regulatory T cells in normal conditions. CCR4+ T cells are implicated
in the pathology of asthma and other inflammatory diseases and T-cell
malignancies.

KW-0761 is a humanized monoclonal antibody targeting CCR4
utilizing the POTELLIGENT(R) technology platform for the development
of antibody-dependent cell-mediated cytotoxicity- (ADCC) enhanced
antibodies.

About POTELLIGENT(R) Technology

ADCC activity is an important immune mechanism that permits immune
cells to kill targets, e.g. cancer cells. Enhancement of this activity
is one promising approach in the next generation of antibody
technologies.

The POTELLIGENT(R) technology involves the reduction of the amount
of fucose in the carbohydrate structure of an antibody. Research shows
that POTELLIGENT(R) technology significantly enhances the ADCC
activity of antibodies in vitro, thereby increasing the potential for
improved activity in vivo.

About Kyowa Hakko

Kyowa Hakko is a biotechnology-based company focused on two
businesses: pharmaceutical operations engaged in the research and
development, manufacturing, and marketing of prescription drugs; and
bio-chemical operations that handle a variety of products such as
amino acids, nucleic acids, and nutritional supplements/healthcare
products. Its pharmaceutical business places emphasis on research and
development in the fields of oncology, allergy, and the central
nervous system. In Japan, Kyowa Hakko is marketing medications for a
wide range of diseases, including allergy, hypertension, angina
pectoris, and cancer. With the aim of penetrating the global market,
Kyowa Hakko has overseas development bases in the U.S. (Kyowa
Pharmaceutical, Inc. and BioWa, Inc) and in the U.K. (Kyowa Hakko U.K.
Ltd.). In the U.S., the U.K., and China, they are pushing ahead with
the clinical development of new drug candidates as well as the
therapeutic antibody business based on Kyowa Hakko's proprietary
technology (POTELLIGENT(R)) that enhances the activity of antibodies.

Last autumn, Kyowa Hakko announced that the Kyowa Hakko group and
the Kirin group entered into an agreement to merge. Through this
merger, the two groups will endeavor to build a global leader in the
research and development-driven life sciences business based in Japan,
which is centered on pharmaceutical operations with strengths in
biotechnology. The new company "Kyowa Hakko Kirin Co., Ltd." will
start operating on Oct. 1, 2008.

For more information on Kyowa Hakko, KW-0761 and POTELLIGENT(R)
technology, visit www.kyowa.co.jp/eng/.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was one
of the first companies to realize the new science's promise by
bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, and other
serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to
dramatically improve people's lives. To learn more about our
pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statement: Amgen

This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in our Form 10-K for the year ended Dec.
31, 2007, and in our periodic reports on Form 10-Q and Form 8-K. Amgen
is providing this information as of the date of this news release and
does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new information,
future events or otherwise.

No forward-looking statement can be guaranteed and actual results
may differ materially from those Amgen projects. Discovery or
identification of new product candidates cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can
be no guarantee that any particular product candidate will be
successful and become a commercial product. Further, preclinical
results do not guarantee safe and effective performance of product
candidates in humans. The complexity of the human body cannot be
perfectly, or sometimes, even adequately modeled by computer or cell
culture systems or animal models. The length of time that it takes for
Amgen to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and Amgen expects similar
variability in the future. Amgen develops product candidates
internally and through licensing collaborations, partnerships and
joint ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be not
as effective or as safe as Amgen may have believed at the time of
entering into such relationship. Also, Amgen or others could identify
safety, side effects or manufacturing problems with Amgen's products
after they are on the market. Amgen's business may be impacted by
government investigations, litigation and products liability claims.
Amgen depends on third parties for a significant portion of its
manufacturing capacity for the supply of certain of its current and
future products and limits on supply may constrain sales of certain of
its current products and product candidate development.

In addition, sales of Amgen's products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments and
domestic and international trends toward managed care and healthcare
cost containment as well as U.S. legislation affecting pharmaceutical
pricing and reimbursement. Government and others' regulations and
reimbursement policies may affect the development, usage and pricing
of Amgen's products. In addition, Amgen competes with other companies
with respect to some of its marketed products as well as for the
discovery and development of new products. Amgen believes that some of
its newer products, product candidates or new indications for existing
products, may face competition when and as they are approved and
marketed. Amgen's products may compete against products that have
lower prices, established reimbursement, superior performance, are
easier to administer, or that are otherwise competitive with its
products. In addition, while Amgen routinely obtains patents for its
products and technology, the protection offered by its patents and
patent applications may be challenged, invalidated or circumvented by
its competitors and there can be no guarantee of Amgen's ability to
obtain or maintain patent protection for its products or product
candidates. Amgen cannot guarantee that it will be able to produce
commercially successful products or maintain the commercial success of
its existing products. Amgen's stock price may be affected by actual
or perceived market opportunity, competitive position, and success or
failure of its products or product candidates. Further, the discovery
of significant problems with a product similar to one of Amgen's
products that implicate an entire class of products could have a
material adverse effect on sales of the affected products and on
Amgen's business and results of operations.

The scientific information discussed in this news release related
to Amgen's product candidates is preliminary and investigative. Such
product candidates are not approved by the U.S. Food and Drug
Administration (FDA), and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates. Only
the FDA can determine whether the product candidates are safe and
effective for the use(s) being investigated.

Amgen, Thousand Oaks
Anne McNickle, 805-447-5890 (w) (media)
323-868-5827 (mobile)
Cory Rivera 805-447-1060 (investors)
or
Kyowa Hakko Kogyo Co., Ltd.
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan 100-8185
Tetsuro Kuga, Public Relations
Tel: +81-3-3282-1903
Fax: +81-3-3282-0990
e-Mail: info@kyowa.co.jp
URL: www.kyowa.co.jp/eng/index.htm

Copyright Business Wire 2008