Merck will not file an application for regulatory approval of rolofylline in 2009 as initially planned because a pivotal study of the adenosine A1 receptor antagonist failed to meet its primary or secondary efficacy endpoints. Merck had thought the drug had potential to be the first major acute heart failure therapy that preserves renal function and improves outcomes after an earlier pilot study showed an overall trend toward efficacy (1Start-Up, September 2007). Merck said June 5 that rolofylline did no better than placebo in the 2,033-patient PROTECT study in improving symptoms of acute heart failure, nor did it reduce the risk of death or cardiovascular or renal re-hospitalization versus placebo by 60 days after treatment. Merck plans to present more explicit results at a meeting later this year. Rolofylline was not expected to be a big seller, but the loss of yet another Phase III compound, particularly a cardiovascular drug, is a blow for Merck - and drives home the rationale for its merger with Schering-Plough (2"The Pink Sheet," March 16, 2009, p. 18)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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