Waiting For Blockbusters: Osteoporosis Market Burdened With Black Box Warnings, Reimbursement Woes, And Spare Pipelines
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Actavis’ purchase of Warner Chilcott will lower the former’s overall tax rate significantly, expand its specialty pharma business to 25% of total revenues, and provide global critical mass – all necessary responses to a future that includes fewer opportunities for small molecule generics and greater pricing pressures.
New bone-targeted agents for osteoporosis must clear significant obstacles to succeed in a highly generic market, but safety concerns with established agents like bisphosphonates and calcitonin offer a foothold. Phase III anabolic candidates from Amgen and Radius Health aim to build new bone, the holy grail of osteoporosis treatment, but R&D in new anti-resorptive mechanisms to halt bone breakdown also continues.
A March 5 joint meeting of the FDA advisory committees for Reproductive Health Drugs and Drug Safety and Risk Management will consider whether the benefit of taking calcitonin salmon, a hormone that increases the amount of calcium in the bones, to treat postmenopausal osteoporosis outweighs the potential risk of cancer; in July 2012, the European Medicines Agency concluded the risk with long-term use was too great and eliminated the osteoporosis indication for calcitonins.