Amgen 2007 Annual Report Download - page 54

on the market” and “— Our sales depend on payment and reimbursement from third-party payers, and, to the ex-
tent that reimbursement for our products is reduced, this could negatively impact the utilization of our
products.”)
Further, on October 29, 2007, the EMEA issued a press release about upcoming changes to product in-
formation for ESAs stipulating a uniform target Hb range for all ESAs of 10 g/dL to 12 g/dL with a warning not
to exceed a concentration of 12 g/dL. We continue to be in discussions with the EMEA to finalize updates to
ESA labels. If recommendations from the March 13, 2008 ODAC meeting were to influence the EMEA to add
additional safety labeling to the class of ESAs, the reimbursement, use and sales of Aranesp®in Europe could be
materially adversely affected.
Before we commercialize and sell any of our product candidates, we must conduct clinical trials in humans;
if we fail to adequately manage these trials we may not be able to sell future products and our sales could
be adversely affected.
Before we can sell any products, we must conduct clinical trials which demonstrate that our product candi-
dates are safe and effective for use in humans for the indications sought or our existing products are safe and
effective for use in humans in new indications sought. Additionally, we may be required to conduct additional
trials as a condition of the approval of our label or as a result of perceived or existing safety concerns. The results
of these clinical trials are used as the basis to obtain regulatory approval from regulatory authorities such as the
FDA. Clinical trials are experiments conducted using our product candidates in human patients having the dis-
eases or medical conditions we are trying to address. Conducting clinical trials is a complex, time-consuming and
expensive process. We are required to conduct clinical trials using an appropriate number of trial sites and pa-
tients to support the product label claims we are seeking or to support our existing label. The length of time,
number of trial sites and patients required for clinical trials vary substantially according to the type, complexity,
novelty and intended use of the product candidate or the extent of the safety concerns, postmarketing issues and/
or exposure to patients and therefore, we may spend several years and incur substantial expense in completing
certain trials. Our ability to complete our clinical trials in a timely fashion depends in large part on a number of
key factors including protocol design, regulatory and institutional review board approval and the rate of patient
enrollment in clinical trials. Patient enrollment is a function of several factors, including the size and location of
the patient population, enrollment criteria and competition with other clinical trials for eligible patients. As such,
there may be limited availability of patients who meet the criteria for certain clinical trials. Delays in planned
clinical trials can result in increased development costs, delays in regulatory approvals, associated delays in
product candidates reaching the market and revisions to existing product labels. In addition, in order to increase
the number of patients available for enrollment for our clinical trials, we have and will continue to open clinical
sites and enroll patients in a number of new geographic locations where our experience conducting clinical trials
is more limited, including Russia, China, India and some Central and South American countries either through
utilization of third-party contract clinical trial providers entirely or in combination with local staff. Conducting
clinical trials in locations where we have limited experience requires substantial time and resources to identify
and understand the unique regulatory environments of individual countries. If we fail to adequately manage the
design, execution and regulatory aspects of our large, complex and regulatory diverse clinical trials, our clinical
trials and corresponding regulatory approvals may be delayed or we may fail to gain approval for our product
candidates altogether or could lose our ability to market existing products in certain therapeutic areas or alto-
gether. If we are unable to market and sell our product candidates or are unable to obtain approvals in the
timeframe needed to execute our product strategies, our business and results of operations would be materially
adversely affected. Additional information on our clinical trials 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 con-
tained on our website is not intended to be a part of this filing.)
Patients may also suffer adverse medical events or side effects in the course of our, our licensees, partners or
independent investigator’s clinical trials of our products that may delay the clinical program, require additional or
longer trials to gain approval, prohibit regulatory approval of our product candidates or additional indications for
our currently approved products, or may render the product candidate commercially infeasible or limit our ability
to market existing products in certain therapeutic areas or at all. For example, as a result of observing an in-
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