Amgen 2010 Annual Report Download - page 31

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Worldwide Nplate»sales for the years ended December 31, 2010, 2009 and 2008 were $229 million,
$110 million and $17 million, respectively.
Our outstanding material patents for romiplostim are described in the following table.
Territory General Subject Matter Expiration
U.S. Thrombopoietic compounds 1/19/2022
Europe(1) Thrombopoietic compounds 10/22/2019
(1) 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.
Any products or technologies that are directly or indirectly successful in treating thrombocytopenia in
splenectomized and non-splenectomized adults with chronic ITP negatively impact Nplate»sales. The following
table reflects currently marketed products that compete with Nplate»in the United States and Europe. The table
may not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. Promacta»GlaxoSmithKline plc
(“GSK”)
Europe Revolade»GSK
Prolia»/XGEVA
TM
(denosumab)
In 2010, we launched Prolia»and XGEVA
TM
, both of which contain the same active ingredient but which are
approved for different indications, patient populations, doses and frequencies of administration. We have a
collaboration agreement with Glaxo Group Limited (“Glaxo”), a wholly owned subsidiary of GSK, for the
commercialization of denosumab in certain countries. (See Business Relationships — Glaxo Group Limited.)
Prolia»
On June 1, 2010, the FDA approved Prolia»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. We estimate that the majority of potential
U.S. Prolia»patients are covered under Medicare and the remaining patients under commercial plans. (See
Reimbursement.) Future U.S. product sales for Prolia»will depend on the willingness of primary care physicians to
prescribe, the availability of reimbursement for and patient acceptance of the product.
On May 25, 2010, the EC granted marketing authorization for Prolia»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. The timing of reimbursement authority approval
of pricing in individual EU countries will vary by country, which could follow the EC approval by many months. For
example, on July 1, 2010, Prolia»received reimbursement authority in Germany. On October 27, 2010, the National
Institute for Health and Clinical Excellence (“NICE”) in the United Kingdom (“UK”) recommended Prolia»for
National Health Service (“NHS”) reimbursement as a treatment option for certain postmenopausal women who are
at increased risk of primary and secondary osteoporotic fractures if other treatments available on the publicly-
funded NHS are unsuitable.
Worldwide Prolia»sales for the year ended December 31, 2010 were $33 million.
15