Disappointing results were recently presented on Merck’s (MRK) anti-clotting candidate, vorapaxar, at the American Heart Association. Results from the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study showed that vorapaxar failed to meet its primary endpoint.
Results were presented from the TRACER study which compared vorapaxar plus standard of care to placebo plus standard of care in 12,944 patients with acute coronary syndrome (ACS).
Besides failing to achieve its primary endpoint, a higher rate of bleeding was observed in the vorapaxar treatment arm compared to the standard of care. There was also a three-fold increase in intracranial hemorrhage (bleeding within the brain).
Vorapaxar is being developed by Merck for the prevention of thrombosis and the reduction of cardiovascular events. Besides the TRACER study, vorapaxar is currently in another study – TRA-2P [a prevention study in patients who have experienced a previous heart attack or ischemic stoke or who have documented peripheral artery disease (PAD)].
The TRACER study results did not come as a major surprise as earlier this year, Merck had announced that an increase in intracranial hemorrhage was associated with the candidate in patients with a history of stroke.
Merck had also announced that a Data and Safety Monitoring Board (DSMB), after reviewing the safety and efficacy data of the two trials, had recommended that the TRACER study should be discontinued.
Merck is currently awaiting results from the TRA-2P study. Once results are out in early 2012, the company will decide on the regulatory path for vorapaxar.
Neutral on Merck
We currently have a Neutral recommendation on Merck, which carries a Zacks #3 Rank (short-term ). With vorapaxar, Merck is looking to carve a position in a market which is dominated by players like Bristol-Myers Squibb Co.’s (BMY) Plavix, Eli Lily & Co.’s (LLY) Effient and AstraZeneca plc’s (AZN) Brilinta. However, the increase in bleeding associated with vorapaxar could make it challenging for the candidate to take share once approved.
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