Amgen 2013 Annual Report Download - page 30

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, India, China, South
Korea, the Philippines, Singapore 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. Further, we must ensure the timely production, distribution and delivery
of the clinical supply of our product candidates to the numerous and varied clinical trial sites. If we fail to adequately manage the design, execution and
regulatory aspects of our large, complex and regulatorily diverse clinical trials or manage the production or distribution of our clinical supply, corresponding
regulatory approvals may be delayed or we may fail to gain approval for our product candidates or could lose our ability to market existing products in certain
therapeutic areas or altogether. 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 could be materially and adversely affected.
We rely on independent third-party clinical investigators to recruit subjects and conduct clinical trials in accordance with the applicable study protocols
and laws and regulations. Further, we rely on unaffiliated third-party vendors to perform certain aspects of our clinical trial operations. We also may acquire
companies that have ongoing clinical trials. These trials may not be conducted to the same standards as ours; however, once an acquisition has been
completed we assume responsibility for the conduct of the trial, including any potential risks and liabilities associated with the past and prospective conduct
of those trials. If regulatory authorities determine that we or others, including our licensees or the independent investigators selected by us or by a company we
have acquired, have not complied with regulations in the R&D of a product candidate, a new indication for an existing product or information to support a
current indication, they may refuse to accept trial data from the site, not approve the product candidate or new indication or maintain approval of the current
indication in its current form or at all, and we would not be able to market and sell it. If we were unable to market and sell our products or product candidates,
our business and results of operations could be materially and adversely affected.
In addition, some of our clinical trials involve drugs manufactured and marketed by other pharmaceutical companies. These drugs may be administered
in a clinical trial in combination with one of our product candidates or in a head-to-head study comparing the products' relative efficacy and safety. In the event
that any of these vendors or pharmaceutical companies have unforeseen issues that negatively impact the quality of their work or creates a shortage of supply,
our ability to complete our applicable clinical trials and/or evaluate clinical results may also be negatively impacted. As a result, this could adversely affect our
ability to file for, gain or maintain regulatory approvals worldwide on a timely basis, if at all.
Patients may also suffer adverse medical events or side effects in the course of our, our licensees, partners or independent investigators' clinical trials
which could:
•delay the clinical trial program;
•require additional or longer trials to gain approval;
•prohibit regulatory approval of our product candidates or new indications for existing products; and
•render the product candidate commercially unfeasible or limit our ability to market existing products completely or in certain therapeutic areas.
Clinical trials must be designed based on the current standard of medical care. However in certain diseases, such as cancer, the standard of care is
evolving rapidly. In these diseases, the duration of time needed to complete certain clinical trials may result in the design of such clinical trials being based on
standards of medical care that are no longer the current standards when such trials are completed, limiting the utility and application of such trials. We may
not obtain favorable clinical trial results and may not be able to obtain regulatory approval for new product candidates, new indications for existing products
or maintenance of our current labels on this basis.
Even after a product is on the market, safety concerns may require additional or more extensive clinical trials as part of a pharmacovigilance program of
our product or for approval of a new indication. For example, in connection with the June 2011 ESA label changes, we also agreed to conduct additional
clinical trials examining the use of ESAs in CKD. Additional clinical trials we initiate, including those required by the FDA, could result in substantial
additional expense and the outcomes could result in additional label restrictions or the loss of regulatory approval for an approved indication, each of which
could have a material adverse effect on the sales of our products, our business and results of operations. Additionally, any negative results from such trials
could materially affect the extent of approvals, the use, reimbursement and sales of our products.
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