For the Treatment of Osteoporosis, Patent Expiries of Key Agents Will Trigger a Further Decline in Sales for the Bisphosphonates Drug Class Through 2021

For the Treatment of Osteoporosis, Patent Expiries of Key Agents Will Trigger a Further Decline in Sales for the Bisphosphonates Drug Class Through 2021

Decision Resources

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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that bisphosphonates will continue to dominate current and future prescriptions for osteoporosis. However, patent expiries of risedronate (Warner Chilcott/Eisai’s Actonel/Atelvia, Takeda’s Benet, generics), zoledronate (Novartis’s Reclast/Aclasta, generics) and ibandronate (Roche/GlaxoSmithKline’s Boniva/Bonviva, generics) will mean that the decline in sales of this drug class, which started following the loss of market exclusivity for alendronate (Merck’s Fosamax/Teijin’s Bonalon, generics), will persist through 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

The Pharmacor advisory service entitled also finds that sales of denosumab (Amgen/GlaxoSmithKline/Daiichi Sankyo’s Prolia) have not been as robust as many key opinion leaders had expected. Prolia sales will continue to be constrained by competition from less expensive generic agents and physician perception that denosumab-treated patients are at risk of many of the same rare but severe side effects seen with bisphosphonates, due to denosumab’s antiresorptive mechanism of action.

Interviewed thought leaders consider Merck’s cathepsin K inhibitor odanacatib and the sclerostin inhibitors (most notably Amgen/UCB’s AMG-785/CDP-7851, the most advanced agent in this drug class) among the most exciting agents that will emerge over the next ten years, based on their potential to stimulate healthy bone formation.

“The early closure of the Phase III fracture trial of odanacatib due to robust efficacy is very promising for this agent. If—as experts anticipate—the full data for odanacatib demonstrates fracture protection and a robust safety profile, this drug will win blockbuster status for Merck,” said Decision Resources Analyst Matthew Scutcher, Ph.D. “And, with regard to the sclerostin inhibitors, despite their likely premium pricing and requirement for injections, relatively infrequent administration and strong anabolic efficacy will yield significant sales.”

The launch of daily teriparatide (Eli Lilly’s Forteo/Forsteo) and once-weekly teriparatide (Asahi Kasei’s Teribone) in Japan gives patients in that market their first access to anabolic agents. Similarly, the approval of monthly minodronate (Ono/Astellas’s Recalbon/Bonoteo) gives Japanese patients their first access to an oral bisphosphonate dosed less often than weekly. These agents are likely to drive significant growth in the Japanese market over the forecast period.

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