Amgen 2010 Annual Report Download - page 45

ganitumab (AMG 479) which is expected to enter into a phase 3 trial in the United States for first-line metastatic
pancreatic cancer in 2011. We have the right to participate in the promotion of the products in Japan. In addition, we
entered into a collaboration agreement with Takeda for the worldwide development and commercialization of our
product candidate motesanib in the oncology area. Each party has the right to participate in the commercialization
of motesanib in the other party’s territory.
Daiichi Sankyo Company, Limited
In July 2007, we entered into a collaboration and license agreement with Daiichi Sankyo, which provides
Daiichi Sankyo the exclusive rights to develop and commercialize denosumab in Japan in postmenopausal
osteoporosis (“PMO”), oncology and certain other indications. As part of the agreement, Amgen received exclusive
worldwide rights to certain Daiichi Sankyo intellectual property to the extent applicable to denosumab.
Fresenius Medical Care North America
In October 2006, we entered into a five-year sole sourcing and supply agreement with an affiliate of Fresenius
Medical Care North America (“Fresenius North America”) (a wholly owned subsidiary of Fresenius Medical Care),
on its behalf and on behalf of certain of its affiliates, whereby Fresenius North America agreed to purchase, and we
have agreed to supply, all of Fresenius North America’s commercial requirements for ESAs for use in managing the
anemia of its hemodialysis patients in the United States and Puerto Rico, based on forecasts provided by Fresenius
and subject to the terms and conditions of the agreement.
Government Regulation
Regulation by government authorities in the United States and other countries is a significant factor in the
production and marketing of our products and our ongoing R&D activities.
In order to clinically test, manufacture and market products for therapeutic use, we must satisfy mandatory
procedures and safety and effectiveness standards established by various regulatory bodies. In the United States, the
Public Health Service Act, the Federal Food, Drug and Cosmetic Act (“FDCA”) and the regulations promulgated
thereunder, as well as other federal and state statutes and regulations govern, among other things, the raw materials
and components used in the production, research, development, testing, manufacture, quality control, labeling,
storage, record keeping, approval, advertising and promotion, and distribution of our products. Failure to comply
with the applicable regulatory requirements may subject us to a variety of administrative and/or judicially imposed
sanctions. The sanctions could include the FDA’s refusal to approve pending applications, withdrawals of
approvals, delay or suspension of clinical trials, warning letters, product recalls, product seizures, total or partial
suspension of our operations, injunctions, fines, civil penalties and/or criminal prosecution.
Clinical Development. We must conduct extensive clinical trials designed to establish the safety and efficacy
of product candidates in order to file for regulatory approval to market a product. Product development and approval
within that regulatory framework takes a number of years and involves our expenditure of substantial resources, and
any approval we obtain remains costly for us to maintain. After laboratory analysis and preclinical testing in
animals, we file an investigational new drug application (“IND”) with the FDA to begin human testing. The IND
automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions. In
such a case, we and the FDA must resolve any outstanding concerns before the clinical trial can begin.
Typically, we undertake a three-phase human clinical testing program. In phase 1, we conduct small clinical
trials to investigate the safety and proper dose ranges of our product candidates in a small number of human
subjects. In phase 2, we conduct clinical trials to investigate side effect profiles and the efficacy of our product
candidates in a larger number of patients who have the disease or condition under study. In phase 3, we conduct
clinical trials to investigate the safety and efficacy of our product candidates in a large number of patients who have
the disease or condition under study. The time and expense required for us to perform this clinical testing is
substantial and may vary by product. For example, the clinical trials for the BLA for Prolia»/XGEVA
TM
were large
and required substantial time and resources to recruit patients and significant expense to execute. Historically, our
products have required smaller, shorter trials. Foreign studies performed under an IND must meet the same
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