Amgen 2010 Annual Report Download - page 66

biosimilar products and downward pressure on our product prices, sales and revenues, subject to our ability to
enforce our patents. Further, biosimilar manufacturers with approved products in Europe may seek to quickly obtain
U.S. approval now that the regulatory pathway for biosimilars has been enacted. In addition, critics of the 12-year
exclusivity period in the biosimilar pathway law will likely seek to shorten the data exclusivity period. President
Obama’s proposed 2012 budget includes a proposal to lower the data exclusivity period to seven years, but this
would require new legislation be passed by the Congress. Critics may also encourage the FDA to interpret narrowly
the law’s provisions regarding which new products receive data exclusivity.
We may not be able to develop commercial products.
Successful product development in the biotechnology industry is highly uncertain, and very few R&D projects
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, 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
• 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
• 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 refractory
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 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 generic
manufacturers of pharmaceutical products are expanding into the biotechnology field with increasing frequency.
These companies may have greater resources than we do. In addition, some of our competitors may have technical
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