Company is in Discussions with FDA About U.S. Prescribing Information for Erythropoiesis-Stimulating Agents
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Feb. 28, 2007--Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has invited the Company to participate at an upcoming meeting of the Oncologic Drugs Advisory Committee (ODAC). The Company's understanding is that the ODAC will review progress made by Amgen and other sponsors in delineating the effects of erythropoiesis-stimulating agents (ESAs) on survival and tumor progression in cancer patients. The ODAC meeting is scheduled for May 10, 2007.
"We look forward to providing an update to the ODAC on the Aranesp(R) (darbepoetin alfa) 103 trial involving cancer patients with anemia not due to chemotherapy. We have recently posted a detailed synopsis of the study results on public Web sites, including clinicalstudyresults.org and clinicaltrials.gov," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of research and development for Amgen.
"The upcoming ODAC meeting will also provide a forum for the review of our ongoing Aranesp pharmacovigilance program," Dr. Perlmutter continued, "which we undertook following the May 2004 ODAC meeting, including a review of data then available from the Aranesp 145 trial involving patients with previously untreated small cell lung cancer." Dr. Perlmutter noted that the Aranesp 145 trial has reached its pre-specified number of events. Amgen is now collecting data from the trial and expects to announce topline results from this study in May.
Additionally, Amgen is in discussions with the FDA with the goal of updating patient safety information on all ESA labels that will take the form of a boxed warning and will apply to both nephrology and oncology indications for the class of approved ESAs. While Amgen's interactions with the FDA are ongoing and exact language for the updated prescribing information is not final, the company is committed to providing timely and appropriate communications to patients and physicians. When the updated prescribing information is final, Amgen will inform healthcare professionals about the revisions to the U.S. prescribing information through a "Dear Healthcare Professional" letter and will post the letter and updated prescribing information on Amgen's web site, www.amgen.com.
Amgen's top priority is patient safety. Aranesp is indicated for the treatment of chemotherapy-induced anemia and anemia associated with chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. EPOGEN(R) (Epoetin alfa) is indicated for the treatment of anemia associated with CKD, for patients on dialysis. The dosing instructions recommend targeting hemoglobin levels not to exceed 12 g/dL. Amgen always recommends that physicians and other prescribers carefully follow FDA-approved prescribing instructions.
Amgen has also reconfirmed its 2007 financial guidance.
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 Dec. 31, 2006 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 third 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 U.S. 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 third party suppliers.
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, 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 deep and broad 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.
David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)