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16
Phase 3 clinical trials investigate the safety and efficacy of a product candidate in a large number of patients who have the disease or condition under study;
typically performed with registrational intent.
Phase 2 clinical trials investigate side effect profiles and efficacy of a product candidate in a large number of patients who have the disease or condition
under study.
Phase 1 clinical trials investigate safety and proper dose ranges of a product candidate in a small number of human subjects.
Phase 3 Product Candidate Program Changes
As of February 12, 2015, we had 15 phase 3 programs. As of February 15, 2016, we had 15 phase 3 programs, as three
programs initiated or advanced to phase 3 trials, and three programs were terminated or concluded. These changes are set forth
in the following table:
Molecule Disease / Condition Program Change
AMG 334 Episodic migraine Advanced to phase 3
Brodalumab Psoriasis; Terminated our participation
Psoriatic arthritis Terminated our participation
ENBREL Psoriatic arthritis; Initiated phase 3 study
Rheumatoid arthritis remission Initiated phase 3 study
Trebananib First-line ovarian cancer Terminated
Phase 3 Product Candidate Patent Information
The following table describes our outstanding composition of matter patents that have issued thus far for our product
candidates in phase 3 development that have yet to be approved for any indication. Patents for products already approved for one
or more indications but currently undergoing phase 3 clinical trials for additional indications are previously described. See
Marketing, Distribution and Selected Marketed Products—Patents.
Molecule Territory General Subject Matter Estimated Expiration*
AMG 334 U.S. Polypeptides 2031
Parsabiv™U.S. Compound 2030
Romosozumab U.S. Polypeptides 2026
Europe Polypeptides 2026
* Patent expiration estimates are based on issued patents, which may be challenged, invalidated, or circumvented by
competitors. The patent expiration estimates do not include any term adjustments, extensions or supplemental protection
certificates that may be obtained in the future and extend these dates. Corresponding patent applications are pending in other
jurisdictions. Additional patents may be filed or issued and may provide additional exclusivity for the product candidate or
its use.
Phase 3 and 2 Program Descriptions
The following text provides additional information about selected product candidates that have advanced into human clinical
trials.
AMG 334
AMG 334 is a human monoclonal antibody that inhibits the receptor for calcitonin gene-related peptide. It is being evaluated
for the prophylaxis of migraine. AMG 334 is being jointly developed with Novartis.
Phase 3 studies in episodic migraine are ongoing, and a phase 2 study in chronic migraine is ongoing.
Aranesp®
Aranesp® is a recombinant human protein agonist of the erythropoietin receptor.
In February 2016, we announced that the randomized, double-blind, placebo-controlled phase 3 ARCADE trial met its
primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk
MDS.