Amgen 2007 Annual Report Download - page 52

marketed products other than Sensipar®. These clinical trials must be conducted by us to maintain regulatory ap-
proval and marketing authorization. For example, we have agreed with the FDA to a robust pharmacovigilance
program to continue to study the safety surrounding the use of ESAs in certain cancer indications. (See “— Re-
cent labeling updates to our ESAs and potential future labeling changes or recommendations from the upcoming
March 13, 2008 ODAC meeting may adversely impact the use, sales and reimbursement of our ESAs.” and “Item
1. Business — Postmarketing and Safety Activities.”) Additionally, the approval of VectibixTM in both the United
States and EU were conditioned on us conducting additional clinical trials of the use of VectibixTM as a therapy
in treating mCRC. If results from mandated clinical trials as part of a PMC or pharmacovigilance program are
negative or any risk management activities resulted in decreased use of our products, it could have a material ad-
verse effect on sales of the affected products and on our business and results of operations.
Substantially all of our marketed products are currently approved in the United States and most are ap-
proved in Europe and in other foreign countries for specific uses. However, later discovery of unknown problems
with our products could result in the regulatory activities described above or even the potential withdrawal of the
product in certain therapeutic areas or certain product presentations, or completely, from the market. If new
medical data suggests an unacceptable safety risk or previously unidentified side-effects, we may voluntarily
withdraw, or regulatory authorities may mandate the withdrawal of such product in certain therapeutic areas, or
completely or a recall of a product presentation from the market for some period or permanently. For example in
2006, we initiated a voluntary recall of the Neulasta®SureClick™ pre-filled pen in Europe because of the poten-
tial risk to patients of receiving an incomplete dose and we conducted a voluntary wholesaler recall of a limited
number of lots of ENBREL as a result of a small number of reports of missing, detached or loose rubber caps on
the needle-less syringe filled with diluent liquid by a third-party contract manufacturer and packaged with the vi-
als of ENBREL. Although there have been no observable adverse event trends associated with the Neulasta®
SureClick™ pre-filled pen or with the reports of missing, detached or loose rubber caps on the needle-less sy-
ringe packaged with the ENBREL vials, we may experience the same or other problems in the future resulting in
broader product recalls or adverse event trends. Additionally, if other parties (including our licensees, such as
J&J and Wyeth, or independent investigators) fail to effectively report to regulatory agencies side effects or other
safety concerns that occur from their use of our products in clinical trials or studies or from marketed use, regu-
latory approval may be withdrawn for a product for the therapeutic area in question, or completely, or other risk
management activities may be imposed by regulators.
If regulatory authorities determine that we or our licensees or partners conducting R&D activities on our be-
half have not complied with regulations in the R&D of a product candidate, new indication for an existing
product or information to support a current indication, then they may not approve the product candidate or new
indication or maintain approval of the current indication in its current form or at all, and we will not be able to
market and sell it. If we were unable to market and sell our products or product candidates, our business and re-
sults of operations would be materially and adversely affected. Additionally, safety signals or adverse events or
results from clinical trials or studies performed by us or by others (including our licensees or independent inves-
tigators) from the marketed use of our drugs that resulted in revised safety labeling or restrictions on the use of
our approved products could negatively impact healthcare provider prescribing behavior, use of our products,
regulatory or private health organization medical guidelines and reimbursement for our products all of which
would have a material adverse effect on our business and results of operations. (See “—Our sales depend on
payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is
reduced, this could negatively impact the utilization of our products.” and “— Guidelines and recommendations
published by various organizations can reduce the use of our products.”)
Recent labeling updates to our ESAs and potential future labeling changes or recommendations from the
upcoming March 13, 2008 ODAC meeting may adversely impact the use, sales and reimbursement of our
ESAs.
On March 9, 2007, based upon data from our AoC 103 Study, J&J’s CHOIR study, and preliminary data
from the third-party investigator DAHANCA 10 Study, among others, the FDA approved updated safety in-
formation, including a boxed warning, in the prescribing information for the class of ESAs, including Aranesp®
and EPOGEN®. On May 10, 2007, the ODAC held a panel meeting to discuss the safety/efficacy profile of ESA
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