Amgen 2013 Annual Report Download - page 29

Similarly, some of our products or product candidates may be used in combination with an in vitro companion diagnostic device, such as a test kit. In
some cases, our product candidates or expanded indications of our products used with in vitro companion diagnostic devices may not be approved or may be
substantially delayed in receiving regulatory approval if such devices do not gain or maintain regulatory approval or clearance. For example, the FDA has
informed us that its approval of Vectibix® for the first- and second-line mCRC indications we are seeking will be contingent upon approval of the companion
diagnostic device being developed in collaboration with QIAGEN N.V., which identifies a patient's KRAS gene status. As with drug delivery devices used with
our products, our ability to get and maintain the necessary regulatory approvals for our products or product candidates used with in vitro companion
diagnostic devices can be substantially dependent on whether the manufacturers of such devices meet their contractual responsibilities to us and/or their
obligations to regulatory authorities. Failures by these manufacturers can also result in the significant delays and added costs described above, or even result
in the removal of our product from the market.
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;
•the biosimilar product candidate fails to demonstrate the requisite biosimilarity 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. 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.
We must conduct clinical trials in humans before we can commercialize and sell any of our product candidates or existing products for new
indications.
Before we can sell any products, we must conduct clinical trials to demonstrate that our product candidates are safe and effective for use in humans.
The results of those clinical trials are used as the basis to obtain approval from regulatory authorities such as the FDA and EMA. (See Our current products
and products in development cannot be sold if we do not maintain or gain regulatory approval.) We are required to conduct clinical trials using an appropriate
number of trial sites and patients to support the product label claims. The length of time, number of trial sites and patients required for clinical trials vary
substantially and therefore, we may spend several years and incur substantial expense in completing certain clinical trials. We may have difficulty finding a
sufficient number of clinical trial sites and subjects to participate in our clinical trials, particularly if competitors are conducting similar clinical trials in
certain patient populations. Delays in planned clinical trials can result in increased development costs, delays in regulatory approvals, associated delays in
product candidates reaching the market and revisions to existing product labels.
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