Amgen 2009 Annual Report Download - page 4

The European regulatory authorities
recommended Prolia™ (denosumab) for
approval in Europe last December, and we
announced in January that we have submitted
the information the U.S. Food and Drug
Administration requested in the Complete
Response letter for Prolia™ in the treatment
of postmenopausal osteoporosis—a very
important step on the way to approval. We
expect Prolia™ approval this year in the
United States, Europe, and other regions.
In the United States, we have a world-class
sales force hired and trained; we have a
collaboration in place with GlaxoSmithKline
to commercialize Prolia™ in markets outside
the United States and Japan; and we are
ready to launch worldwide. This is exciting
for patients, and for all of us at Amgen. We
are also enthusiastic about denosumab’s
potential to help people with cancer. In several
common cancers, including prostate and
breast cancers, tumor cells may spread to
bone, causing fractures or other painful and
dangerous complications (known as skeletal-
related events, or SREs). In pivotal studies,
denosumab demonstrated superiority over
zoledronic acid, the standard of care, in
delaying SREs in breast and prostate cancer
and non-inferiority to the standard of care in
solid tumor/multiple myeloma. Data from these
studies will form the basis of our submissions
to regulatory agencies this year for an SRE
indication. This year, we also anticipate results
from an important study of denosumab’s ability
to prevent bone metastases in prostate cancer
patients. Denosumab is perhaps the most
promising product opportunity in the industry
right now, and it was included in TIME’s list of
Top 10 Medical Breakthroughs of 2009.
Delivering fi nancially and making Prolia™
available to patients are important goals we
have set this year. Another important goal is
to advance the pipeline beyond denosumab.
Late last year we were recognized by Scrip
as having the best overall pipeline in the
business. We owe it to patients everywhere
to deliver on that promise. Our pipeline
programs will continue to progress in 2010.
In addition to denosumab in oncology, we
look forward to additional data and fi lings
for Vectibix® (panitumumab) and phase 3
decisions on a number of therapeutic oncology
programs. We are also focused on earlier
programs in new therapeutic areas for Amgen
such as diabetes, asthma, and cardiovascular
disease. Over the past decade we have made
a sustained investment in research and
Access to Our Medicines
We believe people should have access
to our medicines regardless of their ability
to pay. Over the past year, Amgen has
responded to economic conditions by
increasing the scope and number of patient
access programs offered by the company.
We also streamlined our access and
patient assistance services under an
integrated program called Amgen Assist.
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