Amgen 2009 Annual Report Download - page 60

We may not be able to develop commercial products.
Successful product development in the biotechnology industry is highly uncertain, and very few R&D proj-
ects produce a commercial product. We intend to continue to make significant R&D investments. Product
candidates or new indications for existing products (collectively, “product candidates”) that appear promising in
the early phases of development may fail to reach the market for a number of reasons, such as:
• the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated
positive preclinical trial results
• the product candidate was not effective or more effective than currently available therapies in treating a
specified condition or illness
• the product candidate is not cost effective in light of existing therapeutics
• the product candidate had harmful side effects in humans or animals
• the necessary regulatory bodies, such as the FDA, did not approve our product candidate for an intended
use
• the product candidate was not economical for us to manufacture and commercialize
• other parties have or may have proprietary rights relating to our product candidate, such as patent rights,
and will not let us sell it on reasonable terms, or at all
• we and certain of our licensees, partners or independent investigators may fail to effectively conduct clin-
ical development or clinical manufacturing activities
• the regulatory pathway to approval for product candidates is uncertain or not well-defined
For example, after discussions with the FDA we have decided not to file for approval of motesanib in re-
fractory thyroid cancer until there is more clarity on what would constitute an appropriate regulatory filing
package for that indication. Further, several of our product candidates have failed or been discontinued at various
stages in the product development process. For example, in June 2004, we announced that the phase 2 study of
Glial Cell Lined-Derived Neurotrophic Factor (“GDNF”) for the treatment of advanced Parkinson’s disease did
not meet the primary study endpoint upon completion of nine months of the double-blind treatment phase of the
study. The conclusion was reached even though a small phase 1 pilot investigator-initiated open-label study over
a three-year period appeared to result in improvements for advanced Parkinson’s disease patients. Subsequently,
we discontinued clinical development of GDNF in patients with advanced Parkinson’s disease.
Our business may be affected by litigation and government investigations.
We and certain of our subsidiaries are involved in legal proceedings. Civil and criminal litigation is in-
herently unpredictable, and the outcome can result in excessive verdicts, fines, penalties and/or injunctive relief
that affect how we operate our business. Defense of litigation claims can be expensive, time-consuming and dis-
tracting and it is possible that we could incur judgments or enter into settlements of claims for monetary damages
or change the way we operate our business, which could have a material adverse effect on our results of oper-
ations, financial position or cash flows. In addition, product liability is a major risk in testing and marketing
biotechnology and pharmaceutical products. We may face substantial product liability exposure in human clinical
trials and for products that we sell after regulatory approval. Product liability claims, regardless of their merits,
could be costly and divert management’s attention, and adversely affect our reputation and the demand for our
products. Amgen and Immunex have previously been named as defendants in product liability actions for certain
of our products.
We are also involved in government investigations that arise in the ordinary course of our business. We
have received subpoenas from a number of government entities, including the U.S. Attorney’s Offices for the
Eastern District of New York and the Western District of Washington, as well as the Attorneys General of New
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