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Merck surprises some with its plan to seek marketing approval for two drugs despite safety concerns

  • This year Merck (MRK -2.4%) plans to seek U.S. regulatory approval for its osteoporosis drug odanacatib and its anesthesia reversing agent sugammadex. Both products' safety record has held them up in development for years.
  • According to company research chief Roger Perlmutter, in clinical trials there was a numerically higher incidence of stroke and atrial fibrillation in patients taking odanacatib versus placebo. Also, small percentages (0.2%) of patients experienced morphea and (0.01%) femur fractures. Patients taking the cathespin K blocker did not experience disintegration of the jaw which has occurred in rare cases in patients taking bisphosphonates. It would compete with the firm's own Fosamax. Analysts believe the product would generate peak sales of $1B by 2020.
  • The FDA declined to approve the muscle relaxant reverser sugammadex in 2008 citing its association with allergic reactions and bleeding. The product is currently sold under the brand name Bridion in more than 50 countries generating $73M in sales in Q1. Merck apparently feels that it now has enough data to assuage the agency of its concerns. Analysts believe it would generate peak sales of $500M.
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