Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the launch and uptake of Amgen/GlaxoSmithKline's Prolia will drive this agent to garner sales of more than $500 million in 2019 for postmenopausal osteoporosis in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Additional sales of Prolia will come from a number of oncology-related indications, which await regulatory approval.
The Pharmacor 2010 findings from the topic entitled Osteoporosis reveal that uptake of Prolia will be driven by its twice yearly, subcutaneous delivery, which interviewed experts believe will foster better patient compliance than other agents in the market such as generic alendronate and sanofi-aventis/Warner Chilcott's Actonel. Interviewed experts regard Prolia's subcutaneous delivery as more convenient than that of alendronate and Actonel. However, Prolia's uptake in the mature osteoporosis drug market will be constrained by the increasing availability of generic versions of established agents, safety concerns, and its premium price when compared to existing treatments.
"A number of safety issues related to long-term use of bisphosphonates concern both physicians and patients," said Decision Resources Analyst Matthew Scutcher, Ph.D. "Experts we interviewed believe that Prolia is likely to cause many of the same adverse effects as those of the bisphosphonates, thereby negating any safety advantage that would have propelled Prolia to blockbuster status."
The Pharmacor 2010 findings also reveal that the recent withdrawal for marketing authorization (MA) in Europe of Pfizer's selective estrogen receptor modulator (SERM) bazedoxifene is a significant setback for the agent's development in osteoporosis. The withdrawal of bazedoxifene's MA application also casts doubt about the future of new members of the SERM drug class that are in development for osteoporosis and osteopenia.
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