Merck & Co. Inc. (MRK:NYSE)

Merck & Co. Inc. announced that it is confident in the safety and efficacy profiles of ZETIA(R) (ezetimibe) and VYTORIN(R) (ezetimibe/simvastatin), and issued the following comment in response to misinterpretation of results from a small 200-patient imaging study called ARBITER 6. The results of the small ARBITER 6 study do not, in any way, change its view of ZETIA and VYTORIN as effective medicines for fighting high LDL cholesterol. ZETIA and VYTORIN, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol. The results of ARBITER 6 were widely predicted because the study design favored niacin as the patient population selected had well-controlled LDL cholesterol and relatively low HDL cholesterol. Also, it is important to remember that ARBITER 6 is not an outcomes study, and does not have the rigor or size to provide meaningful insight into the effect of either niacin or ezetimibe on clinical outcomes. Merck has reviewed the data from 43 completed shorter-term clinical trials involving approximately 2,400 patients who received ezetimibe alone and 13,600 patients who received ezetimibe with statins, as well as two longer-term studies, and is confident that the data support the safety profiles of ZETIA and VYTORIN as described in their labels.

Merck & Co. Inc. announced the completion of patient enrollment in the TRA 2 P-TIMI 50 clinical trial, a Phase III, randomized, double-blind, placebo-controlled, multinational study of SCH 530348, the company's investigational antiplatelet protease activated receptor-1 (PAR-1) inhibitor. The study, conducted by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, reached its target of more than 26,000 patients. The trial will assess the ability of SCH 530348, a thrombin receptor antagonist, or PAR-1 inhibitor, to prevent major cardiovascular events when added to current antiplatelet regimens (aspirin or aspirin +ADP inhibitor) in patients who have previously experienced a heart attack or stroke or who have peripheral arterial disease. SCH 530348 is also being studied in the treatment of patients with acute coronary syndrome (ACS) in the ongoing Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA-CER) trial, led by Duke Clinical Research Institute. Approximately 7.2 million people worldwide die each year from coronary heart disease, the most common cause of death in Europe and the United States. In spite of advances in antiplatelet and other preventive treatments, there remains a residual risk for further cardiovascular events in patients with established vascular disease.

Richard Clark, the CEO of Merck & Co. said the company is "actively looking" to acquire biotechnology companies in the "single-digit" billions of dollars, but another major acquisition of the size of Schering-Plough is "off the table right now." In an interview, Mr. Clark said Merck is interested in either acquiring outright biotech companies with promising therapies or technologies, or opportunities to partner with them or license rights from them. "A large merger is off the table right now," Mr. Clark said. "There is so much potential and upside with the Merck and Schering-Plough combination, we need to concentrate on that, but certainly" buying a biotech company is a possibility, he said. Among the potential biotech targets for Merck are Incyte Corp. and AMAG Pharmaceuticals Inc., according to Seamus Fernandez, a Leerink Swann analyst.