THOUSAND OAKS, Calif.,
April 10, 2018 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced plans to build a new
state-of-the-art next-generation biomanufacturing plant at its
campus in West Greenwich, R.I. The
new plant, the first of its kind in the
United States (U.S.), will employ Amgen's proven
next-generation biomanufacturing capabilities and manufacture
products for the U.S. and global markets.
A next-generation biomanufacturing plant incorporates multiple
innovative technologies into a single facility, and therefore is
built in half the construction time with approximately one half of
the operating cost of a traditional plant. Next-generation
biomanufacturing plants require a smaller manufacturing footprint
and offer greater environmental benefits, including reduced
consumption of water and energy and lower levels of carbon
emissions.
"Amgen has three decades of experience in biologics
manufacturing, and we are proud of our track record of providing a
reliable supply of high-quality medicines for patients around the
world," said Esteban Santos,
executive vice president of Operations at Amgen. "We are pleased to
build the first commercial scale, next-generation biomanufacturing
plant in the U.S., leveraging Amgen's capabilities and
incorporating the latest technologies."
A comprehensive evaluation of global locations was conducted to
select the location. Following recent U.S. federal tax reform,
which provides company incentives to invest in innovation and
advanced technologies, Amgen made the decision to locate the new
plant in the U.S. Rhode Island was
selected based on the historical success of the Amgen West
Greenwich manufacturing facility, its capabilities and talented
workforce, and quality of living for staff and potential to grow.
The biomanufacturing plant will be built on the current Amgen Rhode
Island 75-acre campus and is expected to create approximately 150
additional highly-skilled manufacturing positions and approximately
200 construction and validation jobs.
"I am thrilled that Amgen is planning to expand and bring new,
highly skilled jobs to Rhode
Island and further enhance the State's life sciences
community and manufacturing expertise," said Rhode Island Governor Gina Raimondo. "We welcome Amgen's future health
care advancements for patients around the world that will come from
this new biomanufacturing plant."
Amgen opened its first next-generation biomanufacturing plant in
Singapore in 2014. This type of
plant offers a highly flexible, modular design which can be
replicated in future facilities, which enables Amgen to increase
production capabilities reliably with greater speed, productivity
and flexibility. Within the plant, the equipment is portable,
smaller and disposable, which provides greater flexibility and
speed when manufacturing different medicines simultaneously. This
eliminates costly and complex retrofitting inherent in standard
facilities and allows Amgen to respond to changing demands with
increased agility, ultimately impacting the speed at which a
medicine is available for patients.
"We are excited that Amgen Rhode Island was chosen as the
location to build the new biomanufacturing plant," said
Tia Bush, vice president of
Operations at Amgen Rhode Island. "It is a testament to our
skilled, dedicated workforce and Amgen's continued presence in
Rhode Island, which will enable
ongoing collaborations with local academic institutions and the
broader Rhode Island community."
The existing Amgen Rhode Island plant was licensed by the U.S.
Food and Drug Administration in September
2005 and houses one of the world's largest mammalian protein
manufacturing facilities. The facility manufactures commercial and
clinical bulk drug substance. Amgen has invested more than
$1.5 billion in its Rhode Island site, adding more than 500,000
square feet of manufacturing, utility, administrative and
laboratory space to the campus. There are 625 full-time staff
members employed at the Amgen Rhode Island campus.
Amgen Rhode Island has been awarded by the Providence
Business News as one of Rhode
Island's Best Places to Work more than 10 times since
2007.
Since 2004, the Amgen Foundation has committed over $4.8 million to support science education and
community programs in Rhode
Island.
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.
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 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.
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, including our
devices, 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. 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. 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. 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 acquire
other companies or products and to integrate the operations of
companies 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
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen