Amgen 2012 Annual Report Download - page 53

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46
• the product candidate did not demonstrate acceptable clinical trial results even though it demonstrated positive preclinical
trial results, for reasons that could include changes in the standard of care of medicine;
• 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 or EMA, did not approve our product candidate for an intended use;
• the product candidate was not economical for us to manufacture and commercialize;
• the biosimilar product candidate fails to demonstrate the requisite bioequivalence to the applicable reference product,
or is otherwise determined to be unacceptable for purposes of safety or efficacy, to gain approval under the biosimilar
pathway;
• 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 clinical development
or clinical manufacturing activities; and
• the regulatory pathway to approval for product candidates is uncertain or not well-defined.
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.
Inability to bring a product to market or a significant delay in the expected approval and related launch date of a new product
for any of the reasons discussed could potentially have a negative impact on our net sales and earnings and could result in a
significant impairment of in-process research and development (IPR&D) or other intangible assets.
Our marketed products face substantial competition.
We operate in a highly competitive environment. Our products compete with other products or treatments for diseases for
which our products may be indicated. Our competitors market products or are actively engaged in R&D in areas where we have
products, where we are developing product candidates or new indications for existing products. In the future, we expect that our
products will compete with new drugs currently in development, drugs currently approved for other indications that may later be
approved for the same indications as those of our products and drugs approved for other indications that are used off-label. Large
pharmaceutical companies and generics manufacturers of pharmaceutical products are expanding into the biotechnology field
with increasing frequency, and some pharmaceutical companies and generics manufacturers have formed partnerships to pursue
biosimilars. In addition, some of our competitors may have technical, competitive or other advantages over us for the development
of technologies and processes. These advantages may make it difficult for us to compete with them to successfully discover,
develop and market new products and for our current products to compete with new products or new product indications that these
competitors may bring to market. As a result, our products may compete against products that have lower prices (including new
generics or biosimilars that come to market as branded products that compete with our products lose patent protection), equivalent
or superior performance, better safety profile, are easier to administer, achieve earlier entry into the market or that are otherwise
competitive with our products.
Concentration of sales at certain of our wholesaler distributors and consolidation of free-standing dialysis clinic businesses
may negatively impact our bargaining power and profit margins.
The substantial majority of our U.S. product sales are made to three pharmaceutical product wholesaler distributors,
AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson Corporation. These distributors, in turn, sell our products