THOUSAND OAKS, Calif.,
Jan. 2, 2020 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced the successful closing of the
transaction to enter into a strategic collaboration with BeiGene
that will significantly accelerate Amgen's plans to expand its
oncology presence in China, the
world's second-largest pharmaceutical market. BeiGene is a
commercial-stage research-based oncology company with an
established and highly experienced team in China, including an approximately 900-person
commercial organization and an approximately 600-person clinical
development organization.
"There continues to be substantial unmet medical need in
China, particularly for patients
with cancer," said Robert A.
Bradway, Amgen's chairman and chief executive officer.
"We have been impressed with what BeiGene has accomplished,
particularly in research, clinical development and
commercialization, and we look forward to working together to
advance new oncology therapeutics for patients in China and around the world."
As previously announced, the terms of the collaboration are:
- Amgen has acquired a 20.5% stake in BeiGene for approximately
$2.8 billion in cash. This represents
a purchase price of $174.85 per
BeiGene American Depositary Share on NASDAQ, a 36% premium to
BeiGene's 30-day volume-weighted average share price as of
Oct. 30, 2019, the day prior to the
signing of the agreements. In addition, Anthony C. Hooper, former executive vice
president of Global Commercial Operations at Amgen, has been
elected to BeiGene's board of directors, effective today.
- BeiGene will commercialize XGEVA® (denosumab),
KYPROLIS® (carfilzomib) and BLINCYTO®
(blinatumomab) in China, during
which time the parties will equally share profits and losses. Two
of these products will revert to Amgen, one after five years and
one after seven years. Following the commercialization period,
BeiGene will have the right to retain one product and will be
entitled to receive royalties on sales in China for an additional five years on the
products returned to Amgen. XGEVA was launched in China in September
2019; New Drug Applications for KYPROLIS and BLINCYTO have
been filed in China.
- Amgen and BeiGene will collaborate to advance 20 medicines from
Amgen's innovative oncology pipeline in China and globally. BeiGene will share global
research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen
will pay royalties to BeiGene on the sales of these products
outside of China, with the
exception of AMG 510, Amgen's first-in-class
KRASG12C inhibitor that is being studied as a
potential treatment for solid tumors. Amgen anticipates utilizing
data from clinical trials conducted in China to advance the development of its
oncology portfolio globally.
- Of the 20 oncology medicines in development, BeiGene will
assume commercial rights in China
for seven years after launch for those that receive approval in
China, including AMG 510. After
this time, BeiGene will retain rights to up to six of these
products in China, excluding AMG
510, while rights on remaining products revert to Amgen. Amgen and
BeiGene will share profits in China equally on these products until the
rights revert to Amgen, after which Amgen will pay royalties to
BeiGene on sales in China for a
period of five years after reversion.
- Amgen will continue to commercialize its non-oncology product
portfolio in China. Last year,
Amgen launched its first-ever product in China, Repatha® (evolocumab), an
LDL cholesterol-lowering treatment proven to reduce the risk of
heart attacks and stroke. Amgen expects to launch a number of
other non-oncology medicines in China over the next several years, including
Prolia® (denosumab), which reduces the risk of fracture
in postmenopausal women with osteoporosis.
- XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in
Amgen's oncology pipeline, will be manufactured at Amgen's existing
facilities.
Since 2011, Amgen has expanded its geographic presence from
approximately 50 to 100 countries, enabling the company to play a
growing role in serving the rapidly increasing demand for better
healthcare around the world. The pharmaceutical market in
China is expected to grow briskly
as access to new medicines continues to improve. With approximately
four million people diagnosed with cancer annually and 2.3 million
deaths from the disease each year, the need for new oncology
treatments in China is
particularly acute and the oncology market is one of the
fastest-growing segments of the overall pharmaceutical market
there.
For more information about Amgen's products, including important
safety information, please visit www.xgeva.com, www.kyprolis.com,
www.blincyto.com, www.repatha.com, and www.prolia.com.
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 biologics manufacturing 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 the world's
largest independent biotechnology company, 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.
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 any statements on the
outcome, benefits and synergies of the BeiGene strategic
collaboration, including the impact on non-GAAP EPS, as well as
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 current reports on 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. 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, including our devices, 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,
including in Puerto Rico, 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. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. 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. 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, some raw materials, medical
devices and component parts for our products are supplied by sole
third-party suppliers. Certain of our distributors, customers and
payers have substantial purchasing leverage in their dealings with
us. 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 collaborate with or acquire other companies or products and to
integrate the operations of companies or in support of products we
have acquired may not be successful. A breakdown, cyberattack or
information security breach could compromise the confidentiality,
integrity and availability of our systems and our data. 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. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen