Amgen 2007 Annual Report Download - page 23

naling and is over-expressed in many human cancers. Vectibix™ is an entirely human IgG2 monoclonal antibody
that binds with high affinity to EGF receptors and interferes with signals that might otherwise stimulate growth
and survival of the cancer cell. The goal of developing entirely human monoclonal antibodies is to offer effective
targeted therapies with lessened risk of immune response against these agents. Vectibix™ received FDA appro-
val in late September 2006 and became commercially available in the United States in October 2006.
On October 24, 2007, we announced changes to the U.S. prescribing information for Vectibix™ based on
the results of the PACCE trial. On December 5, 2007, the European Commission granted a conditional marketing
authorization for Vectibix™ as a monotherapy for the treatment of patients with EGFr expressing mCRC with
non-mutated (wild-type) KRAS genes after failure of standard chemotherapy regimens. (See “Key Develop-
ments” for further discussion.)
We acquired full ownership of Vectibix™ as part of our acquisition of Abgenix, Inc. (“Abgenix”) in April
2006.
Vectibix™ sales for the year ended December 31, 2007 and 2006 were $170 million and $39 million, re-
spectively.
Postmarketing and Safety Activities
We must conduct extensive clinical trials designed to establish the safety and efficacy of our product candi-
dates in order to file for regulatory approval to market a product. After we have obtained approval to market our
products, we monitor adverse events from the use of our products and report these events to regulatory agencies,
along with information from postmarketing surveillance or studies. We may utilize other research approaches to
learn or confirm information about our marketed products, including observational studies and patient registries,
and may engage in risk minimization activities such as physician education initiatives and patient and patient ad-
vocacy group initiatives. We may also conduct or be required by regulatory agencies to conduct further clinical
trials to provide additional information on our marketed products’ safety and efficacy. These additional trials
may include, among other things, studying different doses or schedules of administration that were used in pre-
vious studies, use in other patient populations or other stages of the disease or use over a longer period of time.
Additional trials of this nature are sometimes required by regulatory agencies as a condition of their approval to
market our products; such trials are sometimes referred to as PMCs. Regulatory agencies may also request or re-
quire that we conduct specific studies in order to identify or assess possible safety risks of our marketed products
that are observed or suggested by available scientific data.
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