Amgen and Daiichi Sankyo Announce Agreement for Denosumab in Japan
Amgen Grants Daiichi Sankyo Exclusive Rights to Develop and
Commercialize Denosumab in Japan
THOUSAND OAKS, Calif. & TOKYO--(BUSINESS WIRE)--July 11,
2007--Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited
(TOKYO:4568) today announced a collaboration and license agreement for
the development and commercialization of denosumab in Japan. Denosumab
is a fully human monoclonal antibody that targets RANK Ligand (an
essential mediator of cells that break down bone) and is being
investigated for its potential to treat and prevent a broad range of
bone loss conditions including osteoporosis and bone metastases.
Under the terms of the agreement, Amgen has granted Daiichi Sankyo
exclusive rights to develop and commercialize denosumab in Japan in
post-menopausal osteoporosis and oncology with the potential for
additional indications. As part of the agreement, Amgen will receive
exclusive worldwide rights to certain Daiichi Sankyo intellectual
property to the extent applicable to denosumab.
The financial terms include an upfront payment to Amgen of $20
million. In addition, Daiichi Sankyo will assume all development costs
for denosumab in Japan and will pay approximately $150 million of
expected worldwide development costs for denosumab through 2009. In
consideration of its intellectual property, Daiichi Sankyo is also
eligible to receive milestone payments dependent on the approval of
denosumab in the European Union or Japan, in two indications. In
connection with its activities under the collaboration and license
agreement, Daiichi Sankyo will pay royalties on annual net sales of
denosumab in Japan in amounts commensurate with a major late stage
product for the Japan market.
"Daiichi Sankyo is an ideal partner for denosumab," said Kevin
Sharer, chairman and CEO of Amgen. "Daiichi Sankyo is uniquely
positioned to bring this potential therapy to patients with a wide
spectrum of bone-related diseases in Japan."
"Daiichi Sankyo is thrilled to partner with a world leader in
biotechnology to gain access to this important antibody product," said
Takashi Shoda, president and CEO of Daiichi Sankyo. "We believe that
denosumab has the potential to be a first-in-class, leading product in
Japan for multiple indications within Daiichi Sankyo's therapeutic
areas of focus. Denosumab's potential applicability in oncology makes
it an important part of the foundation for our growing oncology
business." Daiichi Sankyo has a full range of commercial capabilities,
including in the primary care and hospital settings, a track record of
successful large, first-in-class product launches and the financial
strength to ensure appropriate investment in the product.
Denosumab is a fully human monoclonal antibody that targets RANK
Ligand and is being investigated for its potential to prevent and
treat a broad range of bone loss conditions including osteoporosis,
bone metastases, treatment-induced bone loss, multiple myeloma and
bone erosions in rheumatoid arthritis. Denosumab is the first
late-stage investigational therapy that specifically inhibits RANK
Ligand, an essential mediator of the cells that break down bone.
Amgen discovers, develops 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.
About Daiichi Sankyo Company, Limited
DAIICHI SANKYO COMPANY, LIMITED was established in September 2005
as the joint holding company for the DAIICHI SANKYO Group by means of
a stock transfer. Business integration has proceeded steadily since
then, and the integration process was completed in April 2007 with the
merger of Sankyo Co. Ltd. and Daiichi Pharmaceutical Co., Ltd. into
DAIICHI SANKYO. DAIICHI SANKYO is a global pharmaceutical innovator,
continuously generating innovative drugs and services and maximizing
its corporate value. For further details, please refer to the company
Web site at www.daiichisankyo.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, 2006, 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 we project. The Company's results may
be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
regulatory developments (domestic or foreign) involving current and
future products, sales growth of recently launched products,
competition from other products (domestic or foreign), difficulties or
delays in manufacturing our products. In addition, sales of our
products are affected by 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 health care 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 our products.
Furthermore, our research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. We or others could identify safety,
side effects or manufacturing problems with our products after they
are on the market. Our business may be impacted by government
investigations, litigation and products liability claims. Further,
while we routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors. We depend
on third parties for a significant portion of our manufacturing
capacity for the supply of certain of our current and future products
and limits on supply may constrain sales of certain of our current
products and product candidate development. In addition, we compete
with other companies with respect to some of our marketed products as
well as for the discovery and development of new products. 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, some raw
materials, medical devices and component parts for our products are
supplied by sole third-party suppliers.
CONTACT: Amgen, Thousand Oaks
Anne McNickle, 805-447-5890 (work) (media)
Arvind Sood, 805-447-1060 (investors)
Daiichi Sankyo, Tokyo
Masaya Tamae, +81-3-6225-1126 (office)