Amgen 2009 Annual Report Download - page 9

Denosumab: Progress and Promise
A rare and remarkable scientifi c achievement, denosumab, a
fully human monoclonal antibody targeting RANK Ligand, is the
product of a breakthrough in the understanding of bone biology
discovered by Amgen scientists more than 15 years ago.
In 2009, Amgen received a positive opinion from the European
Medicines Agency’s Committee for Medicinal Products for Human
Use (CHMP) for denosumab in the treatment of osteoporosis in
postmenopausal women who are at increased risk of fractures,
and for treating bone loss associated with hormone ablation
treatment in men with prostate cancer who are at increased
risk of fractures. Amgen also announced a collaboration with
GlaxoSmithKline to commercialize Prolia™ (the brand name
for denosumab in postmenopausal osteoporosis, once approved)
in certain international markets. In the United States, Amgen has
completed fi ling for Prolia™ and has responded to the U.S. Food
and Drug Administration’s request for additional information.
Denosumab has also shown potential in the treatment of bone
diseases in the oncology setting. In two pivotal trials, denosumab
showed superiority against Zometa® in delaying the time to
skeletal-related events (SREs) in breast and prostate cancers.
A third trial in solid tumor/multiple myeloma also showed
denosumab was non-inferior to the standard of care in delaying
SREs. Results from these clinical trials will form the basis of
submissions to regulatory agencies for a proposed SRE indication.
“Denosumab demonstrated
superiority over the standard of
care in treating bone complications
in breast cancer, and I believe the
relative ease of the subcutaneous
administration will be important
to patients.”
—Jean-Jacques Body, M.D.,
Ph.D., professor of Internal
Medicine at Université Libre de
Bruxelles, and head, Department
of Medicine, Brugmann University
Hospital in Brussels, Belgium;
investigator in phase 3 study
evaluating denosumab versus
Zometa® for treatment of bone
metastases in patients with
advanced breast cancer
“It is important to diagnose and
treat osteoporosis promptly
because that way, we can help
prevent many fractures. The
keys to success are awareness,
a good doctor-patient relationship,
and a treatment that patients
can follow.”
—Santiago Palacios, M.D.,
director of the Palacios Institute
of Health and Medicine for Women
in Madrid, Spain; investigator in
the pivotal phase 3 study of
denosumab in postmenopausal
osteoporosis
new grants to nonprofi t groups in the Czech Republic, France,
Germany, Italy, Poland, Spain, and Switzerland.
■ The Amgen Foundation supported Massachusetts General
Hospital’s Disparities Solutions Center and the hospital's
Disparities Leadership Program. The yearlong program helps
executives from hospitals, health plans, and other healthcare
organizations across the United States implement strategies
for eliminating racial and ethnic disparities in healthcare.
■ In the aftermath of the devastating earthquake in Haiti on
January 12, 2010, Amgen and the Amgen Foundation donated
$2 million to relief efforts. Amgen staff around the globe generously
contributed their own funds, which were matched by the company
and the Amgen Foundation, resulting in nearly a half million dollars
in additional support of the relief and rebuilding efforts.
■ In 2009, Amgen set multiyear conservation targets for energy,
carbon dioxide emissions, water, fuel efficiency, and waste.
A company-wide “Shift Into Green” campaign encourages and
educates Amgen staff members about ways they can make
a difference in protecting the environment.
Global Expansion
■ Amgen and GlaxoSmithKline (GSK) agreed to collaborate on
commercialization of Prolia™ (denosumab) for postmenopausal
osteoporosis (PMO) in Europe, Australia, New Zealand, and
Mexico once the product is approved in these countries. Amgen
will market Prolia™ for PMO and oncology in the United States and
Canada without a partner. Amgen will also market denosumab for
all oncology indications in Europe and other markets specifi ed in
the agreement. GSK will register and commercialize denosumab
for all indications in countries where Amgen does not currently
market products, including China, Brazil, India, and South Korea.
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 opened commercial operations in Bulgaria, Romania,
and Mexico and a clinical development offi ce in Brazil.
Amgen 2009 Annual Report ■ 7