Monday, January 6, 2014

Merck's Vorapaxar Faces Moment Of Truth Before The Real Trouble Begins

The enormous rough diamond, called vorapaxar, that Merck  (NYSE: MRK  ) picked up in the Schering-Plough merger has been cut smaller and smaller during costly late-stage development. The first big setback was a pricey phase 3 trial that measured the prevention of clinical events in patients with acute coronary syndrome. In November 2011, the company announced that the drug did not meet its original endpoint. This failure basically buried the drug's chances of being a primary blood thinner for anyone at risk of heart attack.

Less than half a year later, Merck presented data from a phase 3 trial that measured vorapaxar's ability to reduce risk of cardiovascular events as a secondary prevention in patients with a previous heart attack or stroke. This trial did reach its endpoint, but there was a significant increase in intracranial hemorrhage among patients that had previously suffered a stroke. Again, the potential patient pool for vorapaxar became smaller.

Soon the Merck will go up against an FDA advisory committee to defend the blood thinner. Read the full article only at The Motley Fool, here.