Treatment With Prolia(R) (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate

Thousand Oaks, California (ots/PRNewswire) - Amgen
today announced new data that showed postmenopausal women with
osteoporosis had significantly greater adherence, compliance, and
persistence during Prolia(R) (denosumab) treatment than during
alendronate treatment, an oral bisphosphonate commonly used to treat
osteoporosis.

Adherence to treatment, which includes both compliance (a measure
of how well patients follow directions for taking medication) and
persistence (a measure of whether patients continue with treatment),
was measured over two years.

Results from the DAPS (Denosumab Adherence Preference and
Satisfaction) study presented at the annual European Congress on
Osteoporosis and Osteoarthritis (ECCEO11-IOF) in Valencia, Spain,
also found that more than 90 percent of patients preferred Prolia as
a treatment option over alendronate. In addition, significantly more
patients were satisfied with denosumab injection compared with
alendronate tablet (mean score of 4.5 vs. 3.2; score scale of 1-5,
higher score, higher satisfaction, p<0.0001).

"Despite the availability of several treatment options, many
postmenopausal women with osteoporosis are not taking their
medication as prescribed and therefore remain at risk for fractures,"
said Professor Nick Freemantle, University of Birmingham, Birmingham,
UK. "Prolia is an important treatment option for patients not only
because of its efficacy and safety, but also because, as this study
suggests, women may be more likely to stay on treatment compared to
weekly oral alendronate."

DAPS Study Results

DAPS was a two-year, multicenter, open-label, crossover study of
250 postmenopausal women with a bone mineral density (BMD) T-score of
less than or equal to -2.0 to greater than or equal to -4.0 at the
lumbar spine, total hip, or femoral neck and no prior bisphosphonate
treatment. Patients were randomized (1:1) to receive either Prolia
every six months in year 1 followed by weekly oral alendronate in
year 2, or receive alendronate in year 1 followed by Prolia in year
2.

In the study, 92.4 percent of the patients preferred Prolia over
alendronate versus 7.6 percent who preferred alendronate (p<0.0001).
Additionally, 91.2 percent preferred Prolia as a treatment option
versus 8.8 percent for alendronate (p<0.0001), and overall
significantly more patients were more satisfied with treatment with
Prolia compared to treatment with oral alendronate.

In patients who received Prolia in the second year of the study,
treatment with Prolia compared to alendronate was associated with
significantly greater:

- adherence (92.5 percent vs. 63.5 percent, p<0.0001),
- compliance (93.4 percent vs. 67.8 percent, p<0.0001), and
- persistence (97.2 percent vs. 71.3 percent, p<0.0001) with treatment.

Patients were considered adherent to treatment if they received
two Prolia injections within 6 months (plus or minus 4 weeks) apart,
or took greater than or equal to 80 percent weekly oral alendronate
and at least two alendronate tablets in the last month, and returned
for the final study visit within an allotted time.

The incidence and types of adverse events (AEs) and serious
adverse events (SAEs) were generally similar between the Prolia and
alendronate patient groups. SAEs were reported in 3.5 percent and 3.9
percent of patients receiving Prolia and alendronate, respectively.

Osteoporosis: Impact, Prevalence and the Role of Adherence

Referred to as a "silent epidemic" by the International
Osteoporosis Foundation (IOF), osteoporosis is a global problem that
is increasing in significance as the population of the world both
increases and ages. The World Health Organization has officially
declared osteoporosis a public health crisis, and the IOF is urging
governments worldwide to make osteoporosis a healthcare priority.

Osteoporosis-associated fractures are a significant cause of
mortality and morbidity. In 2000, the number of osteoporotic
fractures in Europe was estimated at 3.79 million, of which 890,000
were hip fractures.(1) Since 2001, the incidence of hip fractures in
European countries has risen significantly.(2) In the United States
(U.S.), the number of fractures due to osteoporosis is expected to
rise to more than three million by 2025.(3)

The direct medical cost of osteoporotic fractures in Europe is
expected to rise from euro 31.7 billion in 2000 to euro 76.7 billion
in 2050.(4) In 2005, osteoporosis-related fractures were responsible
for an estimated $19 billion in cost in the U.S., and this cost is
expected to rise to approximately $25 billion by 2025.(5)

Postmenopausal women with osteoporosis who have experienced a
fracture are at increased risk for another fracture.(6),(7),(8) Poor
adherence can increase fracture risk and has been associated with
more fracture-related hospitalizations.(9) Yet globally, adherence to
osteoporosis treatments remains low.

- An analysis of data combined over multiple U.S. health plans showed
that approximately 50 percent of patients discontinue oral
bisphosphonate therapy within the first year.(10)
- Data from the UK Health Improvement Network and General Practice
Research Database showed that less than 50 percent of women in the UK
continue osteoporosis therapy after six months.(11)
- In Germany, the IMS(R) Disease Analyser database showed that compliance
with medication helped reduce the risk for fracture, yet only one third
of women in the database were still on treatment after one year.(12)

About Prolia

Prolia is the first approved therapy that specifically targets
RANK Ligand, an essential regulator of osteoclasts (the cells that
break down bone).

Prolia is approved in the European Union (EU) 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 approved in the U.S. 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.

Prolia is available in 12 European countries, the U.S., Canada
and Australia. Applications in the rest of the world are pending.

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

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 may lead to hypocalcaemia. Hypocalcaemia must be corrected
by adequate intake of calcium and vitamin D before initiating
therapy. Osteonecrosis of the jaw (ONJ) has been reported rarely in
clinical studies in patients receiving denosumab at a dose of 60 mg
every 6 months for osteoporosis.

Important U.S. 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 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.

Denosumab Commercialization Collaborations

In July 2009, Amgen and GlaxoSmithKline 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, 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, bone disease, 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 vital medicines, visit http://www.amgen.com.

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CONTACT:
Amgen, Thousand Oaks
Ashleigh Koss: +1-805-313-6151 (media)
Wendy Woods Williams: +41(41)3692-542 (E.U. media)
Arvind Sood: +1-805-447-1060 (investors)

(1) "Facts and statistics about osteoporosis and its impact."
International Osteoporosis Foundation. Accessed at http://www.iofbone
health.org/facts-and-statistics.html#factsheet-category-22 on 4
February 2011

(2) "Osteoporosis in the European Union in 2008: Ten years of
progress and ongoing challenges." Accessed at http://www.iofbonehealt
h.org/publications/eu-policy-report-of-2008.html on 4 February 2011

(3) Burge R, et al. Incidence and economic burden of
osteoporosis-related fractures in the United States, 2005-2025. J
Bone Miner Res. 2007: 22::465-475

(4) "Facts and statistics about osteoporosis and its impact."
International Osteoporosis Foundation. Accessed at
http://www.iofbonehealth.org/facts-and-statistics.html on 4 February
2011

(5) "Fast Facts" National Osteoporosis Foundation. Accessed at
http://www.nof.org/node/40 on 4 February 2011

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

(7) Lindsay R et al. Risk of new vertebral fracture in the year
following a fracture. JAMA. 2001 Jan 17;285(3):320-33.

(8) 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.

(9) Siris ES et al. Adherence to bisphosphonate therapy and
fracture rates in osteoporotic women: relationship to vertebral and
nonvertebral fractures from 2 US claims databases. Mayo Clin Proc.
2006 Aug;81(8):1013-22.

(10) Weycker D. et al. Compliance with drug therapy for
postmenopausal osteoporosis. Osteoporos Int. 2006;17(11):1645-52.
Epub 2006 Jul 22.

(11) Li L, Roddam A, Gitlin M, Taylor A, Shepherd S, Jick S.
Retrospective Analysis of Persistence to Anti-Osteoporosis
Medications in the UK General Practice Research Database (GPRD).
Poster P606. Presented at IOF WCO-ECCEO 2010

(12) Hadji P, Claus V, Steinle T, Kostev K, Intorcia M.
Non-adherence in women with osteoporosis treated with oral
bisphosphonates: German Retrospective cohort Analysis on
Non-aDherence (GRAND). Poster P604. Presented at IOF WCO-ECCEO 2010

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Contact:
Media: Ashleigh Koss, +1-805-313--6151; E.U. Media: Wendy
WoodWilliams, +41(41)3692-542; Investors: Arvind Sood,
+1-805-447-1060