European Commission Approves Amgen's ARANESP for Anaemia Related to Chronic Kidney Failure; New Drug Offers Important Advantages for the Treatment of Anaemia.

Business Editors & Biotech-Industry Writers

LUCERNE, Switzerland--(BUSINESS WIRE)--June 11, 2001

Amgen (Nasdaq:AMGN) today announced that the European Commission has approved ARANESP(R) (darbepoetin alfa) for the treatment of anaemia in chronic kidney failure including patients on and not yet on dialysis.

"ARANESP represents a significant step forward in the treatment of anaemia based on its longer duration of action," said Professor Francesco Locatelli, one of Europe's foremost experts on kidney disease. "We expect patients will prefer this new treatment because it requires fewer injections than existing therapies," said Professor Locatelli, MD of the Azienda Ospedialiera di Lecco, Lecco, Italy.

ARANESP is approved for administration once a week or once every two weeks which should simplify anaemia management for healthcare providers and patients. In contrast to ARANESP, existing therapy (rHuEPO) requires three injections per week for hemodialysis and pre-dialysis patients according to its label.

"After our discovery of rHuEPO in the early `80s, we continued to look for ways to improve therapies that fight the debilitating condition of anaemia," said Kevin Sharer, Amgen's Chairman and Chief Executive Officer. "ARANESP represents the first important therapeutic advance in anaemia management in more than 10 years."

Aart Brouwer, Amgen's Vice President for European operations, added, "In the past four years ARANESP has been studied at 400 key research centers throughout Europe. Our development of ARANESP has established its safety profile and effectiveness in treating anaemia with less frequent dosing compared with rHuEPO."

Anaemia results from the shortage of oxygen-carrying red blood cells that fuel body function. Patients with impaired kidney function often suffer from anaemia because their kidneys no longer produce sufficient amounts of erythropoietin, a hormone that stimulates production of red blood cells. ARANESP(R) stimulates the bone marrow to increase the production of red blood cells resulting in the dramatic improvement of anaemia in chronic kidney failure patients.

Anaemia May Lead to Serious Health Problems

The anaemia associated with chronic kidney failure may exact a heavy toll on patients' health and well being. "Left untreated anaemia can significantly worsen patients' quality of life and may result in serious health problems, including cardiovascular disorders such as left ventricular hypertrophy, a factor in heart failure," said Dr. Iain Macdougall, Consultant Nephrologist, King's College, London. "ARANESP should help patients and their physicians overcome barriers that currently hinder anaemia treatment, notably the problem associated with multiple injections," said Dr. Macdougall.

"In developing ARANESP, we embarked on the most extensive and thorough clinical program we've ever undertaken," said Anthony Gringeri, Amgen's head of ARANESP product development. "Comparing ARANESP directly with rHuEPO, the results were clear -- ARANESP has a safety and efficacy profile comparable with rHuEPO and does offer advantages for patients and caregivers including less frequent dosing."

"Amgen remains committed to developing ARANESP in order to evaluate its use in other therapeutic indications," said Mr. Sharer.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Amgen is headquartered in Thousand Oaks, CA, USA, with European headquarters in Lucerne, Switzerland.

This news release contains forward-looking statements that 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 Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where 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.

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 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. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.

In addition, while Amgen routinely obtains patents for our products and technology, the protection offered by Amgen patents and patent applications may be challenged, invalidated or circumvented by our competitors.

Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of June 11, 2001, and does not plan to update this information until its next press release and expressly disclaims any duty to update information contained in this press release.

Note to Editors: Amgen International Press Conference: To hear more about this important announcement, and have the opportunity to interview leading experts, Amgen is hosting an international press conference during the European Dialysis and Transplantation Association meeting in Vienna on Monday 25th June, where new treatment guidelines will also be discussed. For details contact Sally Baxandall in the UK on + 44 207 318 8304.

A copy of the ARANESP(R) package insert is available upon request. An electronic version of this news release may be accessed via our web site at www.amgen.com. Visit the Corporate Center and click on Amgen News. 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 Amgen News section of the web site.