Amgen 2012 Annual Report Download - page 37

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30
In December 2012, we reported the results from a phase 2 adult ALL relapsed refractory study at a medical meeting. Phase
2 studies in adult patients with relapsed/refractory and minimal residual disease of ALL and a phase 2 study in adult patients with
NHL are ongoing.
Omecamtiv mecarbil
Omecamtiv mecarbil is a small molecule activator of cardiac myosin. It is being investigated for the treatment of heart
failure. We are developing this product in collaboration with Cytokinetics, Inc.
A phase 2 study of an intravenous formulation of omecamtiv mecarbil in patients with left ventricular systolic dysfunction,
who are hospitalized with acute heart failure, is ongoing.
Amgen Development of Biosimilars
As previously announced, we are collaborating with Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.) to develop and
commercialize, on a worldwide basis, several oncology antibody biosimilar medicines. The products our collaboration is pursuing
include biosimilar versions of bevacizumab (sold by Genentech/Roche under the brand name Avastin®), trastuzumab (sold by
Genentech/Roche under the brand names Herceptin®/Herclon®), rituximab (sold by Roche under the brand names Rituxan®/
Mabthera®) and cetuximab (sold by Eli Lilly/BMS under the brand name Erbitux®).
We are also working to develop biosimilar versions of adalimumab (sold by AbbVie under the brand name HUMIRA®) and
infliximab (sold by Janssen/Merck under the brand name 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.
Phase 3 Product Candidate Program Changes
As of February 10, 2012, we had 12 phase 3 programs. As of February 11, 2013, we had 14 phase 3 programs, as six programs
had advanced into phase 3 trials, three programs had concluded and all rights to one program were out-licensed. These changes
are set forth in the following table:
Molecule Disease / Condition Program Change
AMG 145 Hyperlipidemia Advanced to phase 3
Aranesp®Anemia in heart failure Concluded - failed to meet primary endpoint(s)
Brodalumab (AMG 827) Psoriasis Advanced to phase 3
Ganitumab Pancreatic cancer Concluded - failed to meet primary endpoint(s)
Prolia® (denosumab) Glucocorticoid-induced osteoporosis Advanced to phase 3
Sensipar®/Mimpara®
(cinacalcet)
Cardiovascular disease in patients with
secondary hyperparathyroidism and CKD
undergoing maintenance dialysis
Concluded - failed to meet primary endpoint(s)
Rilotumumab Gastric cancer Advanced to phase 3
Romosozumab (AMG 785) PMO Advanced to phase 3
Motesanib First-line NSCLC Licensed all rights to this program to Takeda(1)
XGEVA® (denosumab) Cancer-related bone damage (SREs) in
patients with multiple myeloma
Advanced to phase 3
(1) See Business Relationships.