Merck Moves Forward With Odanacatib Filing; FDA Accepts MK-3475 Filing
This article was originally published in The Pink Sheet Daily
At a May 6 investor day, Merck’s R&D head Roger Perlmutter revealed the safety issues that have been delaying the company’s late-stage osteoporosis drug and tried to renew confidence in the treatment.
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The big pharma will establish a new oncology unit focused on bringing its anti-PD-1 immunotherapy MK-3475 to market as part of a massive R&D overhaul aimed at lowering costs while driving innovation. Merck isn’t one of the industry’s leading oncology players and may not have as much R&D expertise in the area as rivals, but it might not ultimately matter – as long as MK-3475 gets to market.
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.
Merck’s delay of filing an NDA for its osteoporosis drug odanacatib surprised analysts, but Merck remained mum on its reasoning in a year-end earnings call on Feb. 1.