In a surprising move, the FDA approved Amgen’s (AMGN) osteoporosis drug
Prolia (denosumab) two months earlier than the scheduled date, after it
had caused several months delay in the drug’s marketing. The question
is, why scientists label Prolia a breakthrough and why most analysts
expect it to become a blockbuster, generating billions of dollars in
Assessment of breakthrough drugs entails many
intellectual practices that require knowledge of history that would
confirm the absence of precedents in the same category and science that
enables evaluating the drug’s structure and understanding the
physiological and pathological pathways of the body system targeted for
treatment. These are usually followed by a hypothetical assumption of
efficacy based on the results collected from all the above studies.
Confirmation of the degree of both safety and efficacy, however, comes
only with the results of well-planned clinical trials.
confirms that being a fully human monoclonal antibody, Prolia becomes
the first biological drug to be developed for osteoporosis. To
understand Prolia’s action and effect, one has to know first that two
kinds of cells control bone formation: The osteoclasts, which remove
bone tissue mineralized matrix and break up the organic bone in a
process known as bone resorption and the osteoblasts that are involved
in bone formation. So, while osteoclasts resorb bone, osteoblasts make
bone. These antagonistic actions enable the two cells to be in control
of bone formation.
Amgen’s drug Prolia binds to and inhibits the
action of the receptor activator of nuclear factor kappa B ligand,
(RANKL), the principal mediator of osteoclastic bone resorption. This
inhibition favors bone building by osteoblasts over bone resorption by
the osteoclasts. In addition, it is known that aberrant activation of
nuclear factor kappa B is observed in many cancers. The suppression of
the same nuclear factor by Prolia would limit the proliferation of
cancer cells, making the drug a potential therapeutic for cancer.
Moreover, the same nuclear factor is also a key player in the
inflammatory response. Prolia’s could also be a potential therapeutic
candidate for inflammatory diseases, which are many and affect a large
number of patients who are at the age of developing osteoporosis. As a
matter of fact, results of clinical studies with Prolia, while
confirming its efficacy and safety in treating postmenopausal
osteoporosis have also demonstrated positive results in bone metastasis,
rheumatoid arthritis, multiple myeloma and, giant cell tumor of bone.
Confirming these results, which Amgen is in the process of doing through
conducting more clinical trials, would be huge positive news for the
patients, the company and for Amgen’s shareholders.
good news for the sufferers of osteoporosis who are vulnerable to bone
fractures is that the drug will be available within the next two weeks.
Good news for investors is that the cost of the drug will be $825 per
60-milligram injection based on wholesale acquisition cost. Considering
the fact that the drug will be administered only twice a year, the
annual cost becomes less than that of conventional drugs. In case the
drug will be used for cancer or debilitating inflammatory conditions, or
other life-threatening conditions, the annual cost of the drug would
become much higher, as the drug will have to be used more frequently.
seems that many analysts estimate the product could generate for Amgen
$3.3 billion in annual global sales in 2014. Some of those analysts
believe that the sales will be around $700 Millions in the first year,
and climb higher and higher slowly in the beginning until they reach
between $3B-$4B in 2014. In case the drug will be approved for cancer
and inflammatory diseases, the sales, some estimate, would reach over
$7B-$8B a year.
That’s not bad. No? More...