THOUSAND OAKS, Calif. and
TOKYO, July
13, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo; TSE:
4568) today announced the execution of an exclusive agreement to
commercialize nine biosimilars in Japan. The deal includes several biosimilars
in late-stage development, including biosimilars of adalimumab,
bevacizumab and trastuzumab.
Under the terms of the agreement, Amgen will remain responsible
for the development and manufacturing of the biosimilars. Daiichi
Sankyo will file for marketing approval and be responsible for
distribution and commercialization in Japan, while Amgen will have a limited right
to co-promote the products.
"Amgen is excited to collaborate with Daiichi Sankyo as we seek
to drive adoption and build confidence in biosimilars as a means of
enhancing patient access to more affordable therapeutic options
worldwide," said Scott Foraker, vice
president and general manager of Biosimilars at Amgen.
Amgen will retain all additional distribution and
commercialization rights for the biosimilar programs outside of
Japan. Specific financial terms of
the agreement were not disclosed.
About Amgen Biosimilars
Amgen Biosimilars is committed
to building upon Amgen's experience in the development and
manufacturing of innovative human therapeutics to expand Amgen's
reach to patients suffering from serious illnesses. Biosimilars
offer the potential to increase patient access to vital medicines,
and Amgen is well positioned to leverage its more than 35 years of
experience in biotechnology to create high-quality biosimilars and
reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com and follow
us www.twitter.com/amgenbiosim.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us
on www.twitter.com/amgen.
About Daiichi Sankyo
Daiichi Sankyo Group is
dedicated to the creation and supply of innovative pharmaceutical
products to address diversified, unmet medical needs of patients in
both mature and emerging markets. With over 100 years of scientific
expertise and a presence in more than 20 countries, Daiichi Sankyo
and its 16,000 employees around the world draw upon a rich legacy
of innovation and a robust pipeline of promising new medicines to
help people. In addition to a strong portfolio of medicines for
hypertension and thrombotic disorders, under the Group's 2025
Vision to become a "Global Pharma Innovator with Competitive
Advantage in Oncology," Daiichi Sankyo research and development is
primarily focused on bringing forth novel therapies in oncology,
including immuno-oncology, with additional focus on new horizon
areas, such as pain management, neurodegenerative diseases, heart
and kidney diseases, and other rare diseases. For more information,
please visit: www.daiichisankyo.com.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, 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.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product 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 us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop 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 we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, 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. 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 product liability claims. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
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, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, 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 many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. The discovery of significant problems with a product
similar to one of our products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. Our stock price is volatile and may be affected by a
number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Daiichi Sankyo, Tokyo
Koji Ogiwara, +81 (3) 62251126
(Corporate Communications Department)
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SOURCE Amgen