Merck & Co gets all clear to continue Vytorin study; FDA warns on Pfizer's Zithromax

US pharma giant Merck & Co (NYSE: MRK) said yesterday that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT trial has completed its much awaited planned review of study data and recommended that the study continue.

Merck’s shares jumped 3.5% to $45.19 in early trading, as the news eased investors concerns. The study is looking at whether Vytorin (ezetimibe and simvastatin), with annual sales of $1.75 billion, can significantly reduce heart attacks, strokes and heart-related deaths compared with Merck’s older, Zocor (simvastatin), which has lost patent protection. Analysts at Credit Suisse put a net present value for Vytorin of $1.82 per share, 4% of total, for Merck.

The study design calls for the collection of 5,250 clinical endpoints. Merck remains blinded to the actual results of this analysis and to other IMPROVE-IT safety and efficacy data. Questions about the combination drug’s safety and efficacy were first raised about five years ago. IMPROVE-IT is an 18,141 patient event-driven trial, and based on the targeted number of clinical endpoints and the rate at which events are being reported, the trial is projected to conclude in September 2014. The IMPROVE-IT Executive Committee and Merck will continue to monitor the progress of the study, and Merck will update the study timeline if appropriate. No additional interim analyses are planned.