) recently received approval from the US Food and Drug
Administration (FDA) for an additional indication for Xgeva
(denosumab). The FDA approved Xgeva for the treatment of giant
cell tumor of bone (GCTB) that cannot be treated with surgery.
Approval was granted for use in adults and skeletally mature
Amgen had submitted its regulatory application in the US as
well as the EU in Dec 2012. FDA approval was granted after a
priority review was conducted.
Xgeva is currently approved for the prevention of
skeletal-related events (SREs) in patients with bone metastases
from solid tumors. Xgeva sales came in at $748 million in 2012.
Amgen has been working on expanding Xgeva's label into additional
Xgeva is currently in phase III studies for the delay or
prevention of bone metastases in patients with adjuvant breast
cancer and prevention of SRE in patients with multiple myeloma.
Last year, Amgen had received a complete response letter (CRL)
from the FDA for its supplemental biologics license application
s(BLA) for Xgeva for the delay of bone metastases in prostate
Denosumab is also approved under the trade name, Prolia, for
the treatment of osteoporosis in postmenopausal women at
increased risk of fractures or patients who have failed or are
intolerant to other osteoporosis treatments.
Prolia is also approved for increasing bone mass in women at
high risk for fracture receiving adjuvant aromatase inhibitor
therapy for breast cancer and increasing bone mass in men at high
risk for fracture receiving androgen deprivation therapy for
non-metastatic prostate cancer. In Sep 2012, Prolia gained FDA
approval as a treatment for increasing bone mass in men with
osteoporosis at high risk for fracture.
Prolia is approved in the EU for the treatment of osteoporosis
in postmenopausal women at higher risk of fractures and the
treatment of bone loss associated with hormone ablation in men
with prostate cancer at higher risk of fractures. Prolia sales
were $472 million in 2012.
While approval for the GCTB indication is a positive for the
company, we believe the main potential for boosting Xgeva sales
lies in gaining approval for the prevention of bone metastases in
prostate and breast cancer patients.
Amgen currently carries a Zacks Rank #3 (Hold). Amgen should
be able to deliver on its long-term strategy based on expansion
in key markets, launch of new manufacturing technologies, and
pipeline development. However, nearer-term, we remain concerned
about the performance of existing products. We expect 2013 and
2014 to be important years for Amgen with results on several key
Companies that currently look well-positioned include
). While Biogen and Anika are Rank #1 (Strong Buy) stocks,
Alexion is a Rank #2 (Buy) stock.
ALEXION PHARMA (ALXN): Free Stock Analysis
AMGEN INC (AMGN): Free Stock Analysis Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
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