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ARLZ: Acquires U.S. and Canadian Rights to Zontivity® From Merck


Aralez Acquires U.S. and Canadian Rights to Zontivity®

On September 7, 2016, Aralez Pharmaceuticals, Inc. (ARLZ) announced the acquisition of U.S. and Canadian rights to Zontivity® from Merck. As an inhibitor of thrombin-induced platelet aggregation intended to reduce atherothrombotic events in patients with a history of heart attack, we believe Zontivity® will integrate seamlessly into the company’s burgeoning cardiovascular pipeline that includes Fibricor® and YOSPRALA®, which is pending FDA approval with a PDUFA date of September 14, 2016.

Zontivity® (vorapaxar) is an inhibitor of protease-activated receptor-1 (PAR-1), which is the primary receptor for thrombin. The drug inhibits thrombin receptor-activating peptide (TRAP)-induced platelet aggregation in a dose-dependent manner (Macauley et al., 2010), however it does not affect platelet aggregation induced by adenosine diphosphate (ADP), thromboxane A2 (TXA2), or collagen (Siller-Matula et al., 2010).

The FDA approved Zontivity® on May 5, 2014 based on data from the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P TIMI 50) Phase 3 clinical trial that enrolled 26,449 patients with a history of myocardial infarction, ischemic stroke, or peripheral artery disease (PAD) (Morrow et al., 2012). Patients were randomly assigned 1:1 to receive either vorapaxar (2.5 mg) (n=13,225) or placebo (n=13,244) once daily in addition to standard of care treatment (aspirin or clopidogrel therapy). The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, stroke, or urgent coronary revascularization.

Results from the trial showed that the primary endpoint had occurred in 1259 patients (11.2%) in the vorapaxar group compared to 1417 patients (12.4%) in the placebo group (HR=0.87, P<0.001). The rate of cardiovascular death or myocardial infarction was reduced from 8.2% to 7.3% for patients in the placebo and vorapaxar group, respectively (P=0.002). In patients with a qualifying diagnosis of myocardial infarction, treatment with vorapaxar reduced the relative risk of the primary endpoint by 20%.

Since Zontivity® is an anti-clotting...