The US Food and Drug Administration (FDA) recently granted
) Prolia (denosumab) for an additional indication. Prolia can now
be used as a treatment for increasing bone mass in men with
osteoporosis at high risk for fracture.
FDA approval for Amgen's Prolia was based on data from the
multicenter, randomized, double-blind, placebo-controlled phase III
study (ADAMO ) which compared the efficacy and safety of Prolia (60
mg every six months) to placebo in males with osteoporosis. Results
showed that patients in the Prolia arm experienced significantly
greater gains at the lumbar spine compared to patients on placebo
(5.7% vs. 0.9%).
Prolia is already approved in the US 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.
Approval for the new indication should boost Prolia sales. About
2 million men in the US have osteoporosis, according to the
National Osteoporosis Foundation, with an additional 12 million at
Second quarter 2012 Prolia sales came in at $120 million, up
from first quarter 2012 sales of $88 million. Sales were driven by
increased segment share as well as growth in the overall
skeletal-related events segment. Amgen launched a DTC TV campaign
this year which should drive sales further.
Denosumab is also approved under the trade name, Xgeva, for the
prevention of skeletal-related events (SREs) in patients with bone
metastases from solid tumors.
We currently have a Neutral recommendation on Amgen, which
carries a Zacks #3 Rank (short-term 'Hold' rating). With several
key products expected to lose patent protection in the next few
years, Amgen has a lot riding on Prolia/Xgeva's successful
While we are bullish on Prolia/Xgeva, any hiccup, either with
respect to delays in gaining approval for additional indications, a
miss in any of the ongoing phase III programs, delays in the
reimbursement coverage process or safety concerns post-launch, will
weigh heavily on the shares. Other products in the osteoporosis
) Fosamax and
) Evista and Forteo.
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