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Why Amgen’s Prolia is considered a breakthrough and a blockbuster?

Prohost Biotech - Thursday, June 03, 2010
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 revenues?

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. 

History 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. 

Current 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.

It 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?
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