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Amgen Announces FDA Licensure of Two New Manufacturing Facilities; Company Continues to Meet Increased Demand for Its Novel Therapeutics
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 6, 2005--Amgen (Nasdaq:AMGN), the world's largest biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's new manufacturing facilities in West Greenwich, Rhode Island, and Juncos, Puerto Rico for the production of Amgen's therapeutics.
The new manufacturing plant at Amgen's Rhode Island facility has received FDA approval for the production of Enbrel® (etanercept), the company's leading inflammation biologic used in the treatment of diseases such as moderate to severe rheumatoid arthritis, psoriatic arthritis and moderate to severe plaque psoriasis. Amgen's original ENBREL facility in Rhode Island received licensure in December 2002, five months after the plant was acquired by the company. Amgen has invested more than $1.1 billion to add more than 500,000 square feet to its Rhode Island campus, which now houses one of the world's largest biotechnology manufacturing facilities in terms of capacity and square footage.
Amgen's Puerto Rico facility has been licensed for commercial bulk manufacturing of NEUPOGEN® (Filgrastim), the company's product used to decrease the incidence of many types of chemotherapy-related infections and Neulasta® (pegfilgrastim), Amgen's product for decreasing the incidence of neutropenic infections associated with many types of cancer chemotherapy treatments. Amgen is investing $1.2 billion to expand its Puerto Rico site, first operational in 1993. In addition to the new manufacturing facility for NEUPOGEN and Neulasta, Amgen is building a second Puerto Rico facility for the production of EPOGEN® (Epoetin alfa), Amgen's anemia therapy for patients with chronic renal failure on dialysis and Aranesp® (darbepoetin alfa), Amgen's latest product for the treatment of anemia associated with chronic kidney disease and chemotherapy-related anemia. The complete planned expansion at Amgen's Puerto Rico campus will double the square footage of the facility - from 500,000 to one million square feet.
"We are very pleased with the approvals of our two new manufacturing facilities intended to support Amgen's short- and long-term manufacturing capacity planning and meet the increased demand for our marketed therapeutics," said Dennis Fenton, executive vice president, Operations. "Our manufacturing success is grounded in exceptional science and an exceptional team of people who are deeply committed to advancing our ability to serve every patient, every time."
Since Amgen's founding in 1980, the company has been a pioneer in biologics manufacturing, developing some of the first - and most successful - processes for large-scale protein production. The company has built one of the industry's largest manufacturing operations with major production facilities in California, Colorado, Rhode Island, Puerto Rico and Washington state as well as a network of contract manufacturing partners around the world. Currently, Amgen produces more than a third of the world's recombinant protein therapeutics, excluding vaccines and insulin, and is investing billions of dollars to further expand its manufacturing capabilities.
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 broad and deep 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.
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 December 31, 2004, 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, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement policies imposed by first party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible US legislation affecting pharmaceutical pricing and reimbursement. Government 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 side effects or manufacturing problems with our products after they are on the market. 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. In addition, 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. Further, some raw materials, medical devices, and component parts for our products are supplied by sole first party suppliers.
EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.
CONTACT: Amgen, Thousand Oaks Mary Klem, 805-447-4587 (media) Arvind Sood, 805-447-1060 (investors) SOURCE: Amgen