Amgen 2015 Annual Report Download - page 27

19
Amgen Development of Biosimilars
We continue to collaborate with Allergan 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®), in addition
to three other biosimilar molecules. Our biosimilar product candidates are in varying stages of clinical development as described
in the following table:
Biosimilar Status
adalimumab (HUMIRA®) BLA accepted by FDA for review
MAA submitted to EMA
bevacizumab (Avastin®) Phase 3 NSCLC study met primary and key secondary endpoints
trastuzumab (Herceptin®) Phase 3 breast cancer study ongoing
infliximab (REMICADE®) Phase 1 completed
Business Relationships
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, Australia, New Zealand, all Central American, South American, Middle Eastern and African countries and certain countries
in Asia; (ii) darbepoetin alfa and romiplostim 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 Part IV—Note 8, Related party transactions,
to the Consolidated Financial Statements.
K-A has also given Kirin exclusive licenses to manufacture and market: (i) G-CSF and pegfilgrastim in Japan, Taiwan and
South Korea; (ii) darbepoetin alfa, romiplostim and brodalumab in Japan, China, Taiwan, South Korea and in certain other countries
and/or regions in Asia; and (iii) recombinant human erythropoietin in Japan. K-A also gave Kirin and Amgen co-exclusive licenses
to manufacture and market G-CSF, pegfilgrastim and recombinant human erythropoietin in China, which Amgen subsequently
assigned to Kirin, and as a result, Kirin now exclusively manufactures and markets G-CSF and recombinant human erythropoietin
in China. Kirin markets G-CSF, pegfilgrastim, darbepoetin alfa, romiplostim and recombinant human erythropoietin under the
brand names GRAN®/Grasin®, Peglasta®/Neulasta®/G-Lasta®, NESP®/Aranesp®, ROMIPLATE® and ESPO®, respectively. Under
these agreements, Kirin pays K-A royalties based on product sales. In addition, Kirin also receives payments from K-A for
conducting certain R&D activities on its behalf.
K-A has also given J&J exclusive licenses to manufacture and market recombinant human erythropoietin for all geographic
areas of the world outside the United States, China and Japan. Under this agreement, J&J pays royalties to K-A based on product
sales.