Amgen 2007 Annual Report Download - page 48

guidelines included clinical trial guidance for certain biosimilar products including erythropoietins and G-CSFs,
which guidance recommends that applicants seeking approval of such biosimilar products conduct fairly ex-
tensive pharmacodynamic, toxicological, clinical safety studies and a pharmacovigilance program. In the United
States, there currently is no legal approval pathway for the approval of BLAs for biosimilars. A number of events
would need to occur before these products could enter the market, including passage of legislation by Congress
to create a new approval pathway and, depending on the specific provisions of any such legislation, promulgation
of associated regulations or guidance by the FDA. In 2007, several members of Congress expressed interest in
the issue, a number of bills were introduced, the House of Representatives and the Senate held hearings on bio-
similars, and the Senate Committee on HELP voted on legislation in June 2007. However, no final legislation
was passed in either chamber of Congress. Given the continuing interest of Congress in the issue, it is possible
legislation on biosimilars will also be considered in 2008. It is unknown what type of regulatory framework, what
legal provisions, and what timeframes for issuance of regulations or guidance any final legislation would contain.
Until such legislation is created, we cannot predict when biosimilars could appear in the United States.
In general, we have obtained licenses from various parties which we deem to be necessary or desirable for
the manufacture, use or sale of our products. These licenses generally require us to pay royalties to the parties on
product sales. In addition, other companies have filed patent applications or have been granted patents in areas of
interest to us. There can be no assurance any licenses required under such patents will be available for license on
acceptable terms, or at all. We are engaged in various legal proceedings relating to certain of our patents (see
Note 10, “Contingencies” to the Consolidated Financial Statements).
Trade secret protection for our unpatented confidential and proprietary information is important to us. To
protect our trade secrets, we generally require our staff members, material consultants, scientific advisors and
parties to collaboration and licensing agreements to execute confidentiality agreements upon the commencement
of employment, the consulting relationship, or the collaboration or licensing arrangement with us. However, oth-
ers could either develop independently the same or similar information or obtain access to our information.
(See “Item 1A. Risk Factors — If our intellectual property positions are challenged, invalidated, circum-
vented or expire, or if we fail to prevail in present and future intellectual property litigation, our business could
be adversely affected.” and “- Our marketed products face substantial competition and other companies may dis-
cover, develop, acquire or commercialize products before or more successfully than we do.”)
Human Resources
As of December 31, 2007, we had approximately 17,500 staff members, which includes approximately 100
part-time staff members. Of the total staff members as of December 31, 2007, approximately 7,000 were engaged
in R&D, approximately 2,950 were engaged in selling and marketing, approximately 5,600 were engaged in
commercial manufacturing activities and approximately 1,950 were engaged in other activities. There can be no
assurance that we will be able to continue attracting and retaining qualified personnel in sufficient numbers to
meet our needs. None of our staff members are covered by a collective bargaining agreement, and we have
experienced no work stoppages. We consider our staff relations to be good.
Executive Officers of the Registrant
The executive officers of the Company as of January 31, 2008 are as follows:
Mr. Kevin W. Sharer, age 59, has served as a director of the Company since November 1992. Since May
2000, Mr. Sharer has been Chief Executive Officer and President of the Company and has also been Chairman of
the Board since December 2000. From October 1992 to May 2000, Mr. Sharer served as President and Chief Op-
erating Officer of the Company. From April 1989 to October 1992, Mr. Sharer was President of the Business
Markets Division of MCI Communications Corporation (“MCI”). From February 1984 to March 1989,
Mr. Sharer held numerous executive capacities at General Electric Company (“GE”). Mr. Sharer is a director of
Chevron Corporation and Northrop Grumman Corporation.
Dr. Fabrizio Bonanni, age 61, became Executive Vice President, Operations in August 2007. He has served
as Senior Vice President, Manufacturing of the Company since 2004. Dr. Bonanni joined the Company in 1999
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