Denosumab was a biologic product that treated osteoporosis disease. Its Prolia brand was the first and only RANK ligand inhibitor that reduced the breakdown of bones, and its Xgeva brand was a unique drug that treated bone metastases. Patents for both were scheduled to expire between 2017 and 2023. Alternative Treatments
* Exercise(preventive care not a treatment)
* Dietary supplements(preventive care not a treatment)
* Bisphosphonates drugs such as alendronate,risdronate,ibandronate, zolendronic acid(moderate side effects, absence of readily visible benefits, low compliance,rebound effects; * Raloxifene drugs(clots and strokes side effects),
* Teriparatide drugs(increased bone growth, cancer side effects). Total global sales from osteoporosis treatments in 2008 were 7.8B (4.29B in USA). By 2010 about 5.6M of people in US were receiving the treatment. Competitive Brands
Fosamax, Actonel, Boniva, Reclast, Evista, Forteo, generic
The drug was administered by a healthcare professional. It reduced new vertebral fractures by 68%, new nonvertebral fractures by 20%,hip fractures by 40%; increased BMD more than alendronate. 65% more patients preferred demosumab’s twice a year injection to Fosamax’s weekly pills. Users
People older than 50, primarily women
Convenience of use
Amgen estimated that 30.7M in US had osteoporosis or osteopenia with 15.5M diagnosed and a portion (5.6M) receiving treatment. Prolias price per dose was $825 totaling $1,650 per year. Potential Sales are (15.5-5.6M)x$1,650= Aprx.$16.5B Patent advantage. Company’s own research team.
The drug was administered by oncologists or urologists . Found to be superior to Zometa in delaying SREs in patients with advanced breast and prostate cancer. Also found to be superior to placebo, improving metastatic-free survival by 4.2 months and lengthening the time to the...
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