Two-Year Trial Results of Amgen Investigational Therapy for Bone Loss, Denosumab, Show Increased Bone Mineral Density with Twice-Yearly Dosing

Amgen (NASDAQ:AMGN), the world's largest biotechnology company,today announced that twice-yearly subcutaneous injections of denosumab(60 mg) (previously referred to as AMG 162) increased bone mineraldensity (BMD) in the lumbar spine, total hip, distal 1/3 radius andtotal body compared to placebo at 24 months. The study also includedan open label FOSAMAX(R)(1) (alendronate) arm. Investigators reportedon a pre-planned exploratory analysis at the American College ofRheumatology Annual Scientific Meeting in San Diego, California.

The ongoing, multi-center, Phase 2 dose-ranging trial includesresults from 337 healthy postmenopausal women with low BMD whocompleted two years of study. Researchers reported denosumab 60mgincreased BMD of the lumbar spine by 7.4 percent in women administeredthe therapy twice yearly and 6.2 percent for FOSAMAX(R) 70mg weekly.Across all doses and dosing intervals, denosumab increased the BMD ofthe lumbar spine by 4.3 to 9.0 percent over baseline.

"The two-year results showed the continued effect of denosumab inincreasing bone mineral density in postmenopausal patients with lowbone mass," said Michael Lewiecki, M.D., clinical assistant professorof medicine, University of New Mexico School of Medicine, Albuquerque,NM. "These data suggest denosumab, when administered twice a year, mayoffer a promising alternative for the prevention and treatment ofosteoporosis."

Denosumab is designed to target RANK Ligand, a protein that actsas the primary signal to promote bone removal. In many bone lossconditions, RANK Ligand overwhelms the body's natural defense againstbone destruction.

Preclinical models have demonstrated that inhibiting RANK Ligandleads to significant improvements in cortical and trabecular bonedensity, volume and strength.

Denosumab is currently being studied for its potential in a broadrange of bone loss conditions including osteoporosis,treatment-induced bone loss, bone metastases, multiple myeloma andrheumatoid arthritis.

"Because denosumab targets RANK Ligand, it functions in a way thatis entirely different than other bone loss treatments," said WillardDere, M.D., senior vice president of global development and chiefmedical officer, Amgen. "We believe its unique, targeted approach toregulating bone loss may have the ability to transform how we treatthese conditions."

Researchers also reported twice-yearly injections of denosumab (60mg) increased total hip BMD by 5.1 percent after 24 months. FOSAMAX(R)70 mg weekly produced a 3.4 percent increase during the same timeperiod. Denosumab, at all doses and dosing intervals studied,increased total hip BMD from 2.8 to 5.1 percent. Across all doses anddosing intervals, distal 1/3 radius BMD increased from 0.6 to 2.5percent, and total body BMD increased from 0.9 to 4.5 percent.

Occurrence of adverse events was similar among the denosumab,placebo, and FOSAMAX(R) groups and showed no new pattern of events inthe second year of treatment. No neutralizing antibodies to denosumabwere observed throughout the two years.

Denosumab (AMG 162) Study Design

Investigators randomized 412 postmenopausal women, average age 63,with low BMD to receive denosumab, placebo or FOSAMAX(R). The purposeof the study was to determine the safety and efficacy of denosumab onlumbar spine BMD compared with placebo at 12 months. The doses ofdenosumab evaluated included 6, 14 or 30 mg every three months or 14,60, 100 or 210 mg every six months. The researchers administered alldoses of denosumab via subcutaneous injection. Patients receivingFOSAMAX(R) followed the approved indication and oral dosinginstructions of 70 mg once weekly.

At entry, the women averaged -2.1 on their T-scores, adensitometric rating of BMD in which scores between -1.0 and -2.5indicate osteopenia (thinning bone) and below -2.5 indicateosteoporosis, according to the World Health Organization (WHO).

The Need for Bone Loss Treatments

Osteoporosis

Bone loss represents a significant clinical and economic burden.Osteoporosis is a major public health threat for an estimated 44million Americans, or 55 percent of the people 50 years of age andolder. In the U.S. today, 10 million individuals are estimated toalready have the disease and almost 34 million more are estimated tohave low bone mass, placing them at increased risk for osteoporosis.

Of the 10 million Americans estimated to have osteoporosis, eightmillion are women and two million are men. In addition, one in twowomen and one in four men over age 50 will have anosteoporosis-related fracture in their remaining lifetime.

In Europe, recent estimates have stated that approximately 3.8million people have experienced bone fractures related toosteoporosis.

About Amgen

Amgen discovers, develops and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of thefirst companies to realize the new science's promise by bringing safeand effective medicines from lab, to manufacturing plant, to patient.Amgen therapeutics have changed the practice of medicine, helpingmillions 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, Amgenremains committed to advancing science to dramatically improvepeople's lives. To learn more about our pioneering science and ourvital medicines, visit www.amgen.com.

Forward-Looking Statement

This news release contains forward-looking statements that involvesignificant risks and uncertainties, including those discussed belowand others that can be found in Amgen's Form 10-K for the year endedDecember 31, 2004, and in Amgen's periodic reports on Form 10-Q andForm 8-K. Amgen is providing this information as of the date of thisnews release and does not undertake any obligation to update anyforward-looking statements contained in this document as a result ofnew information, future events or otherwise.

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(1) FOSAMAX(R) is a registered trademark of Merck & Co., Inc.