Merck’s Vytorin Litigation Saga Ends With $688 Million Securities Class Action Settlements
This article was originally published in The Pink Sheet Daily
Investors alleged they lost money from the nearly two-year delay in release of results of the Enhance trial; Merck and Schering previously paid $5.4 million to states to resolve Enhance investigation.
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For a three-year period Merck will inform a committee of its board if trial results are not reported within 12 months; the agreement resolves a shareholder derivative suit claiming Schering directors caused results of the Vytorin ENHANCE trial to be suppressed.
In settlement with state attorneys general, the companies agree to pay $5.4 million to cover investigative costs and recommit to routine oversight policies.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.