Amgen 2011 Annual Report Download - page 50

bone mass in men with osteoporosis at high risk for fracture. We also plan to initiate a phase 3 study of Prolia®
for the treatment of Glucocorticoid-Induced Osteoporosis in 2012.
XGEVA®(denosumab)
In April 2011, we announced that we plan to file for the treatment of giant cell tumor of the bone. On
June 27, 2011, we announced the submission of an sBLA to the FDA to expand the indication for XGEVA®to
treat men with castration-resistant prostate cancer to reduce the risk of developing bone metastases. On
February 8, 2012, the FDA convened the ODAC to discuss the sBLA filing. The ODAC panel voted 12 to 1 that
the overall magnitude of benefit demonstrated with early treatment with XGEVA®to delay bone metastases was
not sufficient to conclude a positive risk-benefit ratio in the absence of additional measures impacting quality of
life or other disease outcomes. The FDA has targeted a PDUFA action date of April 26, 2012. A phase 3 study
for the delay or prevention of bone metastases in patients with adjuvant breast cancer is ongoing. We are
planning an additional phase 3 SRE study in patients with multiple myeloma.
Sensipar®/Mimpara®(cinacalcet)
Sensipar®/Mimpara®is an orally-administered small molecule that lowers PTH levels in blood by signaling
through the calcium-sensing receptor in parathyroid tissue to inhibit PTH secretion. It also lowers blood calcium
and phosphorous levels.
The phase 3 E.V.O.L.V.E™ trial, initiated in 2006, is a large (3,800 patient), multi-center, international,
randomized, double-blind study to assess the effects of Sensipar®/Mimpara®on mortality and cardiovascular
morbidity in patients with CKD undergoing maintenance dialysis. The E.V.O.L.V.E™ study completed
enrollment in January 2008 and we anticipate data from the study in 2012.
Sensipar®/Mimpara®is also being evaluated in post renal transplant patients.
Talimogene laherparepvec (formerly known as OncoVEXGM-CSF)
Talimogene laherparepvec is an oncolytic immunotherapy derived from HSV-1. It is being investigated as a
cancer treatment.
On March 4, 2011, we acquired BioVex, a privately held biotechnology company developing treatments for
cancer and the prevention of infectious disease, including talimogene laherparepvec, then in phase 3 clinical
development for the treatment of malignant melanoma and head and neck cancer. On July 29, 2011, we
announced our decision to terminate the phase 3 trial in patients with head and neck cancer. The phase 3 study
for the treatment of malignant melanoma is ongoing.
Vectibix®(panitumumab)
Vectibix®is a monoclonal antibody antagonist of the EGFr pathway. It is being investigated as a cancer
treatment.
In July 2011, we announced that we received Complete Response Letters from the FDA on the first- and
second-line line mCRC sBLAs requesting additional information from the ‘181 and ‘203 studies. A phase 2 study
for the treatment of locally advanced head and neck cancer is ongoing.
AMG 145
AMG 145 is a fully human monoclonal antibody to Proprotein Convertase Subtilisin/Kexin Type 9
(PCSK9), a negative regulator of low-density lipoprotein receptor. AMG 145 is being investigated for the
treatment of hypercholesterolemia.
Phase 1 single and multiple ascending dose studies have been completed. Results of the phase 1 single dose
study were presented at a medical conference in November 2011. In 2011, phase 2 studies of AMG 145 for the
treatment of hypercholesterolemia were initiated.
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