Amgen 2013 Annual Report Download - page 23

In September 2013, we announced results of a phase 2 study of an intravenous formulation of omecamtiv mecarbil in patients with left ventricular
systolic dysfunction who were hospitalized with acute heart failure. A phase 2 dose escalation study to select and evaluate an oral modified release formulation
of omecamtiv mecarbil in subjects with heart failure and left ventricular systolic dysfunction is ongoing.
Onyx Pharmaceuticals
Kyprolis®
Kyprolis® is a novel proteasome inhibitor. It is being investigated as a treatment for patients with multiple myeloma and small-cell lung cancer.
Phase 3 studies in combination with lenalidomide and dexamethasone compared to lenalidomide and dexamethasone in relapsed multiple myeloma; as
monotherapy compared to best supportive care in relapsed and refractory multiple myeloma; in combination with dexamethasone compared to bortezomib in
combination with dexamethasone in relapsed multiple myeloma; and in combination with melphalan and prednisone compared to bortezomib, melphalan and
prednisone in newly diagnosed multiple myeloma are ongoing.
Oprozomib
Oprozomib is an oral proteasome inhibitor. It is being investigated for the treatment of hematologic malignancies including multiple myeloma, with phase
1b/2 studies ongoing.
Amgen Development of Biosimilars
As previously announced, we are collaborating with Actavis, Inc. to develop and commercialize, on a worldwide basis, four oncology antibody
biosimilar medicines. The products our collaboration is pursuing include biosimilar versions of bevacizumab (Avastin ®), trastuzumab (Herceptin®),
rituximab (Rituxan®/Mabthera®) and cetuximab (Erbitux®).
We are also working to develop biosimilar versions of adalimumab (HUMIRA ®) and infliximab (REMICADE®).
Our biosimilar product candidates are in varying stages of regulatory development. We expect that any revenue contribution from these biosimilar
programs, if successful, would not occur for a number of years. We have biosimilar product candidates of bevacizumab, adalimumab and trastuzumab, that
have pivotal studies ongoing, each of which commenced in 2013.
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From time to time, we enter into business relationships, including joint ventures and collaborative arrangements, for the R&D, manufacture and/or
commercialization of products and/or product candidates. In addition, we also acquire product and R&D technology rights and establish R&D collaborations
with third parties to enhance our strategic position within our industry by strengthening and diversifying our R&D capabilities, product pipeline and
marketed product base. These arrangements generally provide for non-refundable, upfront license fees; development and commercial performance milestone
payments; cost sharing; royalty payments and/or profit sharing. The activities under these collaboration agreements are performed with no guarantee of either
technological or commercial success, and each is unique in nature.
Trade secret protection for our unpatented confidential and proprietary information is important to us. To protect our trade secrets, we generally require
counterparties to execute confidentiality agreements upon the commencement of the business relationship with us. However, others could either develop
independently the same or similar information or unlawfully obtain access to our information.
Kirin-Amgen, Inc.
Kirin-Amgen, Inc. (K-A) is a 50-50 joint venture with Kirin Holdings Company, Limited (Kirin). K-A develops and then out-licenses to third parties
certain product rights which have been transferred to this joint venture from Amgen and Kirin.
K-A has given us exclusive licenses to manufacture and market: (i) G-CSF and pegfilgrastim in the United States, Europe, Canada and Australia; (ii)
darbepoetin alfa, romiplostim and brodalumab in the United States, Europe, Canada, Australia, New Zealand, Mexico, all Central and South American
countries and certain countries in Central Asia, Africa and the Middle East; and (iii) recombinant human erythropoietin in the United States. We currently
market pegfilgrastim, G-CSF, darbepoetin alfa, recombinant human erythropoietin and romiplostim under the brand names Neulasta ®,
NEUPOGEN®/GRANULOKINE®, Aranesp®, EPOGEN® and Nplate®, respectively. Under these agreements, we pay K-A royalties based on product sales.
In addition, we also receive payments from K-A for milestones earned and for conducting certain R&D activities on its behalf. See Note 7, Related party
transactions, to the Consolidated Financial Statements.
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