Amgen 2009 Annual Report Download - page 28

the time to the first-and-subsequent SREs). These three studies will form the basis of the clinical evidence pack-
age for denosumab in advanced cancer, which will be submitted to regulatory authorities later in 2010. For more
information, see “Research and Development and Selected Product Candidates.”
Patents and Competition
Our outstanding material patents for denosumab are described in the table below.
Territory General Subject Matter Expiration(1)
U.S. RANKL antibodies 12/22/2017
U.S. Methods of treatment 11/11/2018
U.S. RANKL antibodies 11/28/2023
Europe RANKL antibodies 12/22/2017
Europe Methods of treatment 4/15/2018
Europe RANKL antibodies 2/23/2021
(1) The expiration dates may be subject to change if delays in regulatory approval lead to extensions of patent
terms in the United States and/or supplemental protection in Europe.
The following table and discussion reflect other companies and their currently marketed products that will
compete with denosumab, if approved. This table and discussion of competitor marketed products and potential
competitor products may not be exhaustive. Merck’s patent covering the use of FOSAMAX®to treat bone loss
expired in the United States in February 2008. Following the patent expiry, generic alendronate (“ALN”) became
available from Teva and other companies, which competes with FOSAMAX®.
Therapeutic Area Competitor Marketed Product Potential Competitor
PMO FOSAMAX®Merck
PMO Actonel®Warner Chilcott/Aventis
PMO Boniva®/Bonviva®Roche/GSK
PMO Evista®Eli Lilly
PMO Forteo®/Forsteo™Eli Lilly
PMO Miacalcin®Novartis AG (“Novartis”)
PMO Aclasta®/Reclast®Novartis
PMO Conbriza®Pfizer
PMO Fablyn®Pfizer
Oncology Zometa®Novartis
Oncology Aredia®Novartis
Marketing and Distribution
We maintain sales and marketing forces primarily in the United States, Europe and Canada to support our
currently marketed products and in preparation of the launch of Prolia™. 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, and also 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, as well as providing support to various patient education
and support programs in the related therapeutic areas.
In the United States, we sell primarily to wholesale distributors of pharmaceutical products. We utilize these
wholesale distributors as the principal means of distributing our products to healthcare providers. In early 2008,
ENBREL’s distribution model was converted from primarily being shipped directly to pharmacies to a wholesale
distribution model similar to our other products. In Europe, Aranesp®, Neulasta®and NEUPOGEN®are princi-
pally sold to healthcare providers and/or wholesalers depending upon the distribution practice in each country.
We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits,
requiring letters of credit and obtaining credit insurance, as we deem appropriate.
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