Amgen 2012 Annual Report Download - page 33

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Research and Development and Selected Product Candidates
We focus our R&D on novel human therapeutics for the treatment of grievous illness in the areas of oncology, hematology,
inflammation, bone health, nephrology, cardiovascular and general medicine, which includes neuroscience. We take a modality-
independent approach to R&D with a focus on biologics. Our discovery research programs may therefore yield targets that lead
to the development of human therapeutics delivered as large molecules, small molecules, or other combination or new modalities.
We have major R&D centers in several locations throughout the United States and in the United Kingdom, as well as smaller
research centers and development facilities globally. See Item 2. Properties.
We conduct clinical trial activities using both our internal staff and third-party contract clinical trial service providers. To
increase the number of patients available for enrollment in our clinical trials, we have opened clinical sites and will continue to
open clinical sites and to enroll patients in a number of geographic locations. See Item 1A. Risk Factors — We must conduct
clinical trials in humans before we can commercialize and sell any of our product candidates or existing products for new indications.
Some of our competitors are actively engaged in R&D in areas where we have products or where we are developing product
candidates or new indications for existing products. For example, we compete with other clinical trials for eligible patients, which
may limit the number of available patients who meet the criteria for certain clinical trials. The competitive marketplace for our
product candidates is significantly dependent on the timing of entry into the market. Early entry may have important advantages
in gaining product acceptance, thereby contributing to the product’s eventual success and profitability. Accordingly, we expect
that in some cases, the relative speed with which we can develop products, complete clinical testing, receive regulatory approval
and supply commercial quantities of the product to the market will be important to our competitive position.
In addition to product candidates and marketed products generated from our internal R&D efforts, we acquire companies,
acquire and license certain product and R&D technology rights and establish R&D arrangements with third parties to enhance our
strategic position within our industry by strengthening and diversifying our R&D capabilities, product pipeline and marketed
product base. Those licenses and arrangements generally provide for non-refundable, upfront license fees, R&D and commercial
performance milestone payments, cost sharing, royalty payments and/or profit sharing.
Various public and privately owned companies, research organizations, academic institutions and government agencies
conduct a significant amount of R&D in the biotechnology industry. In pursuing R&D arrangements and licensing or acquisition
activities, we face competition from other pharmaceutical and biotechnology companies that also seek to license or acquire
technologies, product candidates or marketed products from those entities. Accordingly, we may have difficulty entering into R&D
arrangements and licensing or acquiring technologies, product candidates and marketed products on acceptable terms.
See Government Regulation — Clinical Development for a discussion of government regulation over clinical development.
The following table is a selection of certain of our product candidates by phase of development in our therapeutic areas of
focus as of February 11, 2013, unless otherwise indicated. Each disease or condition for our product candidates in phase 3 is listed
separately. Additional product candidate (pipeline) information can be found on our website at http://www.amgen.com. (This
website address is not intended to function as a hyperlink, and the information contained on our website is not intended to be a
part of this filing.) The information in this section does not include other, non-registrational clinical trials, such as the Pegfilgrastim
and Anti-VEGF Evaluation Study (PAVES) trial evaluating Neulasta® (pegfilgrastim) use in patients receiving chemotherapy and
bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer, that we may conduct for purposes
other than for submission to regulatory agencies for their approval of a new product indication. We may conduct non-registrational
clinical trials for various reasons including to evaluate real-world outcomes or to collect additional safety information with the
use of our products. See, for example, the discussion of our ESA pharmacovigilance trials under — Marketed Products — ESAs.