Merck & Co. Inc. (MRK) recently provided an unfavorable update on the development status of its cardiovascular pipeline candidate, vorapaxar. Vorapaxar, in late-stage trials, with a potential filing planned for 2011, is being studied for the reduction of cardiovascular events in patients with atherosclerotic cardiovascular disease.
Merck currently has two trials in progress for the candidate – TRACER, a study in patients with acute coronary syndrome, and TRA-2P (TIMI 50), a study in patients with prior heart attack, stroke and peripheral artery disease.
The combined Data and Safety Monitoring Board (DSMB), after reviewing the safety and efficacy data of the two trials, recommended that the TRACER study should be discontinued.
The DSMB further recommended Merck to discontinue patients in the TRA-2P trial who experienced a stroke prior to entry into the study or during the course of the study. However, patients who entered the trial with a history of a previous heart attack or peripheral arterial disease could continue with the treatment.
Merck plans to report efficacy and safety data from the TRACER trial later in 2011.
The TRACER trial was being conducted to observe the first occurrence of any component of the composite of cardiovascular death, heart attack, stroke, recurrent ischemia with re-hospitalization, and urgent coronary revascularization, compared to active control. Merck completed enrollment in this study in June 2010.
The TRA-2P trial was being conducted to observe the first occurrence of any component of the composite of cardiovascular death, myocardial infarction, stroke, and urgent coronary revascularization compared to placebo. Merck completed enrollment in this study in November 2009.
With vorapaxar, Merck was 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.
Neutral on Merck
We currently have a Neutral recommendation on Merck, which is supported by a Zacks #3 Rank (short-term Hold rating). The DSMB’s recommendation comes as a setback for the company, which is already facing issues like patent expirations of key drugs and European pricing pressure. We believe that Merck will need to make efforts to expand its portfolio through acquisitions and in-licensing deals.
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