THOUSAND OAKS, Calif., July 31, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the groundbreaking of its new next-generation biomanufacturing plant that will be constructed at its West Greenwich, R.I. campus. The new plant is the first-of-its-kind in the U.S. and will use Amgen's proven next-generation biomanufacturing capabilities to manufacture products for the U.S. and global markets.
"Biologics manufacturing is a complex science and has long been a competitive advantage for Amgen," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We are working to extend that advantage even further with a next-generation biomanufacturing plant in Rhode Island that will produce medicines to serve patients around the world suffering from serious illnesses."
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. Within the plant, the equipment is portable, smaller and some components are 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 for its medicines with increased agility, ultimately impacting the speed at which a medicine is available for patients.
"We are thrilled that Amgen has selected Rhode Island as the location for this plant that will be the first-of-its-kind in the United States," said Governor Gina M. Raimondo. "This is more proof that Rhode Island is now successfully competing for economic development opportunities with global companies thanks to our highly skilled workforce, robust academic institutions and exceptional quality of life. Rhode Island is proud to support Amgen in its commitment to developing innovative medicines."
Amgen expects to invest up to $200 million in the approximately 120,000 square foot next-generation manufacturing plant in Rhode Island. This plant is anticipated to create approximately 150 additional highly-skilled manufacturing positions.
"Since its inception in 2002, Amgen Rhode Island has evolved to a multi-product manufacturing facility, which is a testament to our focus on innovation, technology and great staff," said Tia Bush, vice president of Operations at Amgen Rhode Island. "Constructing this next-generation plant in Rhode Island further enhances our manufacturing capabilities within Amgen's global operations network to deliver on our mission to serve patients."
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 campus, adding more than 500,000 square feet of manufacturing, utility, administrative and laboratory space to the campus. There are approximately 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 eleven 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 amgen.com and follow us on 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 break down, 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
Kristen Davis, 805-447-3008 (media)
Tara Urban, 401-218-2538 (media)
Arvind Sood, 805-447-1060 (investors)
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