Amgen 2012 Annual Report Download - page 22

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for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (e.g., corticosteroids,
immunoglobulins). In the EU, Nplate® may also be considered as second-line treatment for adult non-splenectomized ITP patients
where surgery is contraindicated.
Total Nplate® sales were as follows (in millions):
2012 2011 2010
Total Nplate®$ 368 $ 297 $ 229
Our outstanding material patents for romiplostim are described in the following table.
Territory General Subject Matter Expiration
U.S. Thrombopoietic compounds 1/19/2022
U.S. Thrombopoietic compounds 10/22/2019
Europe(1) Thrombopoietic compounds 10/22/2019
(1) This European patent is also entitled to supplemental protection in one or more countries in Europe and the length of any
such extension will vary by country. For example, supplementary protection certificates covering romiplostim have issued
in France, Italy, Spain, and the United Kingdom, and will expire in 2024.
Any products or technologies that are directly or indirectly successful in treating thrombocytopenia in splenectomized and
non-splenectomized adults with chronic ITP could negatively impact Nplate® sales.
The following table reflects companies and their currently marketed products that compete with Nplate® in the United States
and Europe and may not be exhaustive.
Territory Competitor Marketed Product Competitor
U.S. Promacta®GSK
Europe Revolade®GSK
Marketing and Distribution
We maintain sales and marketing forces primarily in the United States, Europe and Canada to support our currently marketed
products. We have also entered into agreements with third parties to assist in the commercialization and marketing of certain of
our products in specified geographic areas. (See Business Relationships.) Together with our partners, we market our products to
healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies. We also market certain
products directly to consumers through direct-to-consumer print and television advertising, as well as through the Internet. In
addition, for certain of our products, we promote programs to increase public awareness of the health risks associated with the
diseases these products treat and we provide support for various patient education and support programs in the related therapeutic
areas. See Government Regulation — FDA Regulation of Product Marketing and Promotion for a discussion of government
regulation of product marketing and promotion.
In the United States, we sell primarily to pharmaceutical wholesale distributors. We utilize those wholesale distributors as
the principal means of distributing our products to healthcare providers. In Europe, we sell principally to healthcare providers and/
or pharmaceutical wholesale distributors depending on the distribution practice in each country. We monitor the financial condition
of our larger customers, and we limit our credit exposure by setting credit limits and, for certain customers, by requiring letters
of credit.
Our product sales to three large wholesalers, AmerisourceBergen Corporation, McKesson Corporation and Cardinal Health,
Inc., each accounted for more than 10% of total revenues for each of the years ended December 31, 2012, 2011 and 2010. On a
combined basis, these wholesalers accounted for approximately 94%, 90% and 88% of our gross product sales in the United States,
respectively and approximately 76%, 72% and 71% of our total worldwide gross revenues, respectively in 2012, 2011 and 2010.
Reimbursement
Sales of all of our principal products are dependent in large part on the availability and extent of coverage and reimbursement
from third-party payers, including government and private insurance plans. Most patients receiving our products are covered by
government healthcare programs or private insurers. Governments may regulate coverage, reimbursement and/or pricing of our
products to control costs or to affect levels of use of our products; and private insurers may adopt or be influenced by government