Amgen 2012 Annual Report Download - page 51

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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.
Further, we rely on unaffiliated third-party vendors to perform certain aspects of our clinical trial operations. 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.
Safety signals, trends, adverse events or results from clinical trials or studies performed by us or by others (including our
licensees or independent investigators) or from the marketed use of our drugs or similar products that result in revised safety-
related labeling or restrictions on the use of our approved products could negatively impact healthcare provider prescribing behavior,
use and sales of our products, regulatory or private health organization medical guidelines and reimbursement for our products,
all of which could have a material adverse effect on our business and results of operations.
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 an out of date standard of medical care, 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. Further, clinical trials conducted
by others, including our licensees, partners or independent investigators, may result in unfavorable clinical trials results that may
call into question the safety of our products in off-label or on label uses that may result in label restrictions and/or additional trials.
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, we initiated Study '782 as part of
our Aranesp® oncology pharmacovigilance program. (See Our ESAs continue to be under review and receive scrutiny by regulatory
authorities.) 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.
We expect to face increasing competition from biosimilars.
We currently face competition in Europe from biosimilars, and we expect to face increasing competition from biosimilars
in the future. In 2010, lawmakers in the United States enacted healthcare reform legislation which included an abbreviated regulatory
pathway for the approval of biosimilars. The EU is already approving biosimilars under such a regulatory pathway. To the extent
that governments adopt more permissive approval frameworks and competitors are able to obtain broader marketing approval for
biosimilars, our products will become subject to increased competition. Expiration or successful challenge of applicable patent
rights could trigger such competition, and we could face more litigation regarding the validity and/or scope of our patents. Our