Amgen 2009 Annual Report Download - page 26

also be considered as second-line treatment for adult non-splenectomized ITP patients where surgery is contra-
indicated.
Worldwide Nplate®sales for the years ended December 31, 2009 and 2008 were $110 million and $17 mil-
lion, respectively.
Our outstanding material patents for romiplostim are described in the table below.
Territory General Subject Matter Expiration
U.S.(1) Thrombopoietic compounds 10/22/2019
Europe(2) Thrombopoietic compounds 10/22/2019
(1) An application for patent term extension has been submitted and is currently pending in the United States.
(2) In some cases, this European patent may also be entitled to supplemental protection in one or more countries
in Europe and the length of any such extension will vary by country.
We currently have an approved REMS for Nplate®, which includes a medication guide, a healthcare pro-
vider communication plan and certain elements to ensure safe use (including restricted distribution, registry and
healthcare provider and patient enrollment).
Promacta®, GlaxoSmithKline plc’s (“GSK”) registered trademark in the United States, is indicated for the
treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to cortico-
steroids, immunoglobulins, or splenectomy, and competes with Nplate®. In December 2009, Revolade®, GSK’s
proposed registered trademark in Europe, received a positive opinion from the CHMP for marketing author-
ization for the treatment of adult chronic ITP splenectomized patients who are refractory to other treatments, and
may compete with Nplate®in the EU, if approved by the European Commission.
Product candidates
We are currently studying new product candidates, including denosumab, and currently marketed products
for new indications, which, if approved, we expect will enter into highly competitive markets. If successful, these
product candidates will face substantial competition from products currently marketed as well as those under de-
velopment by other biotechnology and pharmaceutical companies.
Denosumab Developments
Denosumab is a fully human monoclonal antibody that specifically targets a ligand known as RANKL (that
binds to a receptor known as RANK) which is an essential regulator of osteoclasts. Denosumab is under regu-
latory review and is being studied across a range of conditions, including osteoporosis, treatment-induced bone
loss, bone metastases, multiple myeloma and RA.
The following is a summary of certain key developments that occurred in 2009 and early 2010 with respect
to denosumab:
Prolia™(denosumab) for the Prevention and Treatment of PMO and the Prevention and Treatment
of Bone Loss in Patients Undergoing HALT for either Prostate Cancer or Breast Cancer
In late 2008, we submitted the BLA to the FDA for Prolia™in the treatment and prevention of PMO in
women and bone loss in patients undergoing HALT for either prostate or breast cancer.
On August 13, 2009, we announced the results of our meeting with the FDA’s Advisory Committee for Re-
productive Health Drugs (“ACRHD”) to review the potential use of Prolia™for the treatment and prevention of
PMO in women and the treatment and prevention of bone loss in patients undergoing HALT for either prostate
cancer or breast cancer. The Committee recommended approval of Prolia™for the treatment of PMO and for the
treatment of bone loss in patients undergoing HALT for prostate cancer. The Committee recommended against
approval of Prolia™to treat or prevent bone loss in women with breast cancer undergoing HALT until additional
data are available. The Committee also recommended against approval of Prolia™to prevent bone loss in
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