Prolia(TM) (denosumab) Receives Best New Drug Honor at Scrip Awards

By Amgen, PRNE
Thursday, November 4, 2010

THOUSAND OAKS, California, November 5, 2010 - Amgen (Nasdaq: AMGN) is pleased to announce that it has won the Best New
Drug award for Prolia(TM) (denosumab), a novel treatment approved in the
United States
(U.S.) for women with postmenopausal osteoporosis at high risk
for fracture, at the 2010 Scrip Awards ceremony Nov. 4 in London. Named one
of TIME's Top 10 Medical Breakthroughs of 2009, Prolia is the first treatment
specifically designed to target osteoclasts, the cells that break down bone.

In addition to its novel mechanism of action, the Scrip judges
highlighted Prolia's efficacy in reducing fractures and dosing regimen.
Prolia, the first and only RANK Ligand inhibitor approved in the U.S. and the
European Union (EU), is an every six month subcutaneous injection.

"We are honored to be recognized again by our industry peers with the
Best New Drug award," said Roger M. Perlmutter, M.D., Ph.D., executive vice
president of Research and Development at Amgen. "Only last year we were
recognized by Scrip for our robust pipeline, which at the time included
Prolia. This medicine is the result of more than a decade of work, beginning
with Amgen's discovery of a pathway that regulates bone metabolism and
culminating in this important new treatment option for patients with bone

Osteoporosis is a serious, chronic disease that affects 30 percent of
postmenopausal women in the EU.(i) In the U.S., one in two women over the age
of 50 with postmenopausal osteoporosis will experience a fracture in her
remaining lifetime.(ii) Postmenopausal women with osteoporosis who have
experienced a fracture are at increased risk for another fracture.(iii),(iv),

The annual Scrip Awards are independently judged by a panel of senior
industry experts and are given to biotechnology and pharmaceutical companies
for their contribution to the improvement of healthcare. For more
information, visit the Scrip website

About Prolia

Prolia is approved for use in the U.S., the EU, Canada, Australia and
Switzerland. In the U.S., Prolia is approved for the treatment of
postmenopausal women with osteoporosis at high risk for fracture, defined as
a history of osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available osteoporosis
therapy. In postmenopausal women with osteoporosis, Prolia reduces the
incidence of vertebral, non-vertebral and hip fractures. The U.S. prescribing
information indicates Prolia should be administered by a healthcare

The pivotal three-year Phase 3 Fracture REduction Evaluation of Denosumab
in Osteoporosis every six Months (FREEDOM) study in 7,808 women with
postmenopausal osteoporosis demonstrated that Prolia, administered as a 60mg
subcutaneous injection every six months, compared with placebo at three years
resulted in:(vi)

    -- A 68 percent reduction in vertebral fractures (4.8 percent absolute
       risk reduction). The incidence of new spine fractures was 2.3 percent
       with Prolia vs. 7.2 percent with placebo;
    -- A 40 percent reduction in hip fractures (0.3 percent absolute risk
       reduction). The incidence of hip fractures was 0.7 percent with Prolia
       vs. 1.2 percent with placebo;
    -- A 20 percent reduction in non-vertebral fractures (1.5 percent
       absolute risk reduction). The incidence of non-spine fractures was 6.5
       percent with Prolia vs. 8 percent with placebo;
    -- Significant bone density increases at all key sites measured (8.8
       percent at the lumbar spine, 6.4 percent at the total hip, and 5.2
       percent at the femoral neck).

In the EU, Prolia is approved for the treatment of osteoporosis in
postmenopausal women at increased risk of fractures, and for the treatment of
bone loss associated with hormone ablation in men with prostate cancer at
increased risk of fractures. Prolia is also the first and only product
approved in the EU for the treatment of bone loss associated with hormone
ablation in men with prostate cancer at increased risk of fractures.

Important U.S. Prolia Safety Information

Prolia is contraindicated in patients with hypocalcemia. Pre-existing
hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may
worsen, especially in patients with severe renal impairment. All patients
should be adequately supplemented with calcium and vitamin D.

In the pivotal study, serious infections leading to hospitalizations were
reported more frequently in the Prolia-treated patient group. Serious skin
infections, as well as infections of the abdomen, urinary tract and ear, were
more frequent in patients treated with Prolia. Patients should be advised to
seek prompt medical attention if they develop signs or symptoms of severe
infection, including cellulitis. Endocarditis was reported more frequently in
the Prolia-treated patient group. Epidermal and dermal adverse events such as
dermatitis, rashes, and eczema have been reported. Discontinuation of Prolia
should be considered if severe symptoms develop.

Prolia resulted in significant suppression of bone remodeling. The
significance of these findings is unknown. The long-term consequences of the
degree of suppression of bone remodeling observed with Prolia may contribute
to adverse outcomes such as osteonecrosis of the jaw (ONJ), atypical
fractures, and delayed fracture healing. ONJ has been reported in patients
with Prolia. Patients should be monitored for these adverse outcomes. The
most common adverse reactions (> 5 percent and more common than placebo) were
back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and
cystitis. Pancreatitis has also been reported with Prolia.

Important EU Safety Information

The most common adverse reactions with Prolia were urinary tract
infection, upper respiratory tract infection, sciatica, cataracts,
constipation, rash, pain in extremity. The most serious adverse reactions
were those of skin infections, predominantly cellulitis, reported more
commonly in the Prolia group compared with placebo (0.4 percent vs. 0.1
percent) in postmenopausal osteoporosis studies. In breast and prostate
cancer studies, serious adverse reactions of skin infection were similar in
the Prolia and placebo groups (0.6 percent vs. 0.6 percent). In the Phase 3
placebo-controlled clinical trial in patients with prostate cancer receiving
ADT, an imbalance in cataract adverse events was observed with Prolia
compared with placebo (4.7 percent vs. 1.2 percent placebo). No imbalance in
cataract adverse events was observed in postmenopausal women with
osteoporosis or in women undergoing aromatase inhibitor therapy for
nonmetastatic breast cancer.

Prolia is administered as a single subcutaneous injection of 60mg once
every six months. For further information on Prolia, please visit:

About Denosumab Collaborations

In July 2009, Amgen and GlaxoSmithKline (GSK) announced a collaboration
agreement to jointly commercialize Prolia for postmenopausal osteoporosis in
Europe, Australia, New Zealand and Mexico once the product is approved in
these countries. Amgen will commercialize Prolia's postmenopausal
osteoporosis and potential oncology indications in the U.S. and Canada and
for all oncology indications in Europe and in other specified markets.

In addition, GlaxoSmithKline will register and commercialize denosumab
for all indications in countries where Amgen does not currently have a
commercial presence, including China, Brazil, India and South Korea but
excluding Japan. The structure of the collaboration allows Amgen the option
of an expanded role in commercialization in both Europe and certain emerging
markets in the future.

Amgen and Daiichi-Sankyo Company Limited have a collaboration and license
agreement for the development and commercialization of denosumab in Japan.

About Amgen

Amgen discovers, develops, manufactures 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 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

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    CONTACT: Amgen, Thousand Oaks
    Sarah Reines: +1-805-447-5476 (media)
    Arvind Sood: +1-805-447-1060 (investors)

(i) International Osteoporosis Foundation. Epidemiology. Accessed at
on 28 October 2010.

(ii) National Osteoporosis Foundation. Osteoporosis Fast Facts.
Washington (DC): Accessed at on 28 October 2010.

(iii) Kanis JA et al. A Meta-Analysis of Previous Fracture and Subsequent
Fracture Risk. Bone. 2004;35(2):375-82.

(iv) Lindsay R et al. Risk of new vertebral fracture in the year
following a fracture. JAMA. 2001 Jan 17;285(3):320-3.

(v) Klotzbuecher CM et al. Patients with prior fractures have an
increased risk of future fractures: a summary of the literature and
statistical synthesis. J Bone Miner Res. 2000 Apr;15(4):721-39.

(vi) Cummings SR et al. Denosumab for Prevention of Fractures in
Postmenopausal Women with Osteoporosis. N Engl J Med. 2009; 361(8):756-65.


media, Sarah Reines, +1-805-447-5476, or investors, Arvind Sood, +1-805-447-1060, both of Amgen, Thousand Oaks

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