Moving molecules from laboratory to patients involves years of detailed
investigation and rigorous testing. Clinical development requires enormous
investments in time and resources. It begins with preclinical testing and
proceeds through a series of human clinical trials that establish dosage levels,
test for efficacy and side effects, and, depending on the molecule, may
ultimately seek to measure long-term patient outcomes.
Preclinical studies collect data to show that
a molecule is reasonably safe for use in initial
small-scale clinical trials.
Phase 1 clinical trials investigate safety and
proper dose ranges of a product candidate in
a small number of human subjects.
Phase 2 clinical trials investigate side effect
profiles and efficacy of a product candidate
in a large number of patients who have the
disease or condition under study.
Phase 3 clinical trials investigate the safety
and efficacy of a product candidate in a large
number of patients who have the disease or
condition under study.
These tables are current as of February 3, 2005, and show the status of
selected clinical and preclinical molecules in Amgen's product pipeline.
Amgen's product pipeline will change over time as molecules move through
the drug development process, including progressing to market or failing
in clinical trials, due to the nature of the development process. These
tables contain forward-looking statements that involve significant risks
and uncertainties, including those discussed in Amgen's most recent Form
10-K and in Amgen's periodic reports on Form 10-Q and Form 8-K, and
actual results may vary materially. Amgen is providing this information
as of the date above and does not undertake any obligation to update
any forward-looking statements contained in this table as a result of new
information, future events or otherwise.
For more information on Amgen's product pipeline,
please visit www.amgen.com.
For important safety information about Amgen's
marketed products, please visit www.amgen.com for
links to the product Web sites.
